<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03307005</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00142395</org_study_id>
    <nct_id>NCT03307005</nct_id>
  </id_info>
  <brief_title>Improving Sleep Quality in Heart Failure</brief_title>
  <official_title>Improving Sleep Quality in Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Poor sleep quality is common in patients with heart failure. The limited available evidence&#xD;
      intimates that improving sleep quality in patients with heart failure may improve morbidity&#xD;
      and quality of life in this patient population. However, there is a paucity of evidence&#xD;
      assessing the use of effective pharmacologic therapies in heart failure. The&#xD;
      nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable&#xD;
      benefits over traditional benzodiazepines as a soporific medication. The investigators&#xD;
      hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">January 25, 2019</completion_date>
  <primary_completion_date type="Actual">January 25, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single-site, randomized, parallel, placebo controlled, double blind study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Latency</measure>
    <time_frame>1 week</time_frame>
    <description>Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Sleep Time</measure>
    <time_frame>1 week</time_frame>
    <description>Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Efficiency</measure>
    <time_frame>1 week</time_frame>
    <description>Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>1 week</time_frame>
    <description>a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores &gt;=15 are signify the presence of insomnia</description>
  </other_outcome>
  <other_outcome>
    <measure>Kansas City Cardiomyopathy Questionnaire</measure>
    <time_frame>1 week</time_frame>
    <description>a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Epworth Sleepiness Scale</measure>
    <time_frame>1 week</time_frame>
    <description>a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>1 week</time_frame>
    <description>a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Sleep Disturbance</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zolpidem Tartrate</intervention_name>
    <description>Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>Placebo capsule one per night taken for 7 nights</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21-79 years old&#xD;
&#xD;
          -  HFrEF, EF ≤ 45% (by echocardiography)&#xD;
&#xD;
          -  NYHA functional class I to III&#xD;
&#xD;
          -  Able to give written consent&#xD;
&#xD;
          -  On goal-directed medical therapy for HF, with stable dosing of HF medications for 2&#xD;
             weeks prior to enrollment&#xD;
&#xD;
          -  No hospitalizations for HF within the past month&#xD;
&#xD;
          -  Positive response to experiencing any of the following sleep-related symptoms at least&#xD;
             once a week:&#xD;
&#xD;
          -  Difficulty falling asleep&#xD;
&#xD;
          -  Waking up during the night and having difficulty getting back to sleep&#xD;
&#xD;
          -  Waking up too early in the morning and being unable to get back to sleep.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of sedative-hypnotics, anxiolytic, or benzodiazepines within the previous 2 weeks&#xD;
&#xD;
          -  Current treatment with other sedating medications such as opioids&#xD;
&#xD;
          -  On therapy for pharmacological therapy for depression&#xD;
&#xD;
          -  History of alcohol/drug dependence&#xD;
&#xD;
          -  History of liver disease, HIV, or severe COPD&#xD;
&#xD;
          -  On Thorazine&#xD;
&#xD;
          -  Current use of ketoconazole&#xD;
&#xD;
          -  Current use of tricyclic antidepressants&#xD;
&#xD;
          -  Current use of macrolide antibiotics&#xD;
&#xD;
          -  Current use of anticonvulsant medications&#xD;
&#xD;
          -  Pregnancy. A urine pregnancy test will be performed to exclude pregnancy in potential&#xD;
             subjects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rashmi Aurora, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Campus, Asthma and Allergy Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <results_first_submitted>January 23, 2020</results_first_submitted>
  <results_first_submitted_qc>February 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 11, 2020</results_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zolpidem</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT03307005/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Zolpidem Tartrate</title>
          <description>Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo oral capsule: Placebo capsule one per night taken for 7 nights</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Persons with heart failure and insomnia</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Participants received seven nights of zolpidem 5 mg</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Participants received seven nights of placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.3" lower_limit="43" upper_limit="75"/>
                    <measurement group_id="B2" value="67.5" lower_limit="65" upper_limit="70"/>
                    <measurement group_id="B3" value="63.2" lower_limit="43" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sleep Latency</title>
        <description>Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Participants received seven nights of zolpidem 5 mg</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Participants received seven nights of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Latency</title>
          <description>Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-73.3" lower_limit="-143" upper_limit="0.2"/>
                    <measurement group_id="O2" value="21.9" lower_limit="-5.5" upper_limit="49.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Sleep Time</title>
        <description>Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Placebo oral capsule: Placebo capsule one per night taken for 7 nights</description>
          </group>
        </group_list>
        <measure>
          <title>Total Sleep Time</title>
          <description>Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.8" lower_limit="36.5" upper_limit="125.3"/>
                    <measurement group_id="O2" value="-87.3" lower_limit="-184.5" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sleep Efficiency</title>
        <description>Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Placebo oral capsule: Placebo capsule one per night taken for 7 nights</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Efficiency</title>
          <description>Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.</description>
          <units>sleep efficiency percentage</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" lower_limit="0" upper_limit="17"/>
                    <measurement group_id="O2" value="-5.5" lower_limit="-33" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Insomnia Severity Index</title>
        <description>a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores &gt;=15 are signify the presence of insomnia</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Placebo oral capsule: Placebo capsule one per night taken for 7 nights</description>
          </group>
        </group_list>
        <measure>
          <title>Insomnia Severity Index</title>
          <description>a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores &gt;=15 are signify the presence of insomnia</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline ISI score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="11" upper_limit="24"/>
                    <measurement group_id="O2" value="14" lower_limit="12" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final ISI score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="4" upper_limit="23"/>
                    <measurement group_id="O2" value="13.5" lower_limit="11" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Kansas City Cardiomyopathy Questionnaire</title>
        <description>a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Placebo oral capsule: Placebo capsule one per night taken for 7 nights</description>
          </group>
        </group_list>
        <measure>
          <title>Kansas City Cardiomyopathy Questionnaire</title>
          <description>a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline KCCQ-23 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.7" lower_limit="77" upper_limit="120"/>
                    <measurement group_id="O2" value="99" lower_limit="85" upper_limit="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final KCCQ-23 Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="80" upper_limit="117"/>
                    <measurement group_id="O2" value="100" lower_limit="95" upper_limit="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Epworth Sleepiness Scale</title>
        <description>a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Placebo oral capsule: Placebo capsule one per night taken for 7 nights</description>
          </group>
        </group_list>
        <measure>
          <title>Epworth Sleepiness Scale</title>
          <description>a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline ESS score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="5" upper_limit="16"/>
                    <measurement group_id="O2" value="12.5" lower_limit="8" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final ESS score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="1" upper_limit="16"/>
                    <measurement group_id="O2" value="13" lower_limit="7" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pittsburgh Sleep Quality Index</title>
        <description>a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality</description>
        <time_frame>1 week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Placebo oral capsule: Placebo capsule one per night taken for 7 nights</description>
          </group>
        </group_list>
        <measure>
          <title>Pittsburgh Sleep Quality Index</title>
          <description>a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline PSQI score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="8" upper_limit="14"/>
                    <measurement group_id="O2" value="12" lower_limit="10" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Final PSQI score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" lower_limit="9" upper_limit="15"/>
                    <measurement group_id="O2" value="11" lower_limit="10" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>15 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Zolpidem Tartrate: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Placebo oral capsule: Placebo capsule one per night taken for 7 nights</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rashmi Nisha Aurora, MD, MHS</name_or_title>
      <organization>Johns Hopkins University</organization>
      <phone>443-513-6535</phone>
      <email>rnaurora@jhmi.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03307005
org study id: IRB00142395
nct id: NCT03307005
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Poor sleep quality is common in patients with heart failure. The limited available evidence
      intimates that improving sleep quality in patients with heart failure may improve morbidity
      and quality of life in this patient population. However, there is a paucity of evidence
      assessing the use of effective pharmacologic therapies in heart failure. The
      nonbenzodiazepine, GABA receptor agonist, zolpidem, has been found to have considerable
      benefits over traditional benzodiazepines as a soporific medication. The investigators
      hypothesize that zolpidem will safely improve sleep quality in patients with heart failure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-site, randomized, parallel, placebo controlled, double blind study
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Sleep Latency
time frame: 1 week
description: Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.
measure: Total Sleep Time
time frame: 1 week
description: Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.
measure: Sleep Efficiency
time frame: 1 week
description: Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.
measure: Insomnia Severity Index
time frame: 1 week
description: a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores >=15 are signify the presence of insomnia
measure: Kansas City Cardiomyopathy Questionnaire
time frame: 1 week
description: a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.
measure: Epworth Sleepiness Scale
time frame: 1 week
description: a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.
measure: Pittsburgh Sleep Quality Index
time frame: 1 week
description: a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality
arm group label: Intervention
arm group type: Experimental
arm group label: Control
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Zolpidem Tartrate
description: Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
arm group label: Intervention
intervention type: Drug
intervention name: Placebo oral capsule
description: Placebo capsule one per night taken for 7 nights
arm group label: Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: 79 Years
healthy volunteers: No
last name: Rashmi Aurora, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Heart Failure
mesh term: Zolpidem
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 