<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/NCT03290014</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)365/2015</org_study_id>
    <nct_id>NCT03290014</nct_id>
  </id_info>
  <brief_title>Sleep Quality in (COPD) Patients (COPD: Chronic Obstructive Pulmonary Disease)</brief_title>
  <acronym>COPD</acronym>
  <official_title>Sleep Quality in COPD Patients. A Clinical and Polysomnographic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with COPD, in addition to daytime symptoms, may suffer from nocturnal disturbances.&#xD;
      The frequency of nocturnal problems has been reported to be higher in COPD than in the&#xD;
      general population and it currently affects up to 50% of patients.&#xD;
&#xD;
      The CASIS questionnaire includes 7 questions and it has been recently validated as an&#xD;
      objective tool to evaluate nocturnal symptoms in patients with asthma and COPD. The present&#xD;
      study aims to study the validity of the CASIS questionnaire as a predictor of sleep quality&#xD;
      measured by objective polysomnographic parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep efficiency</measure>
    <time_frame>One night at the sleep unit</time_frame>
    <description>Sleep time/Time in bed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total sleep time</measure>
    <time_frame>One night at the sleep unit</time_frame>
    <description>Total sleep time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arousal index</measure>
    <time_frame>One night at the sleep unit</time_frame>
    <description>number of arousals/hour of sleep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep architecture</measure>
    <time_frame>One night at the sleep unit</time_frame>
    <description>percentage of the different sleep phases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osler test error index</measure>
    <time_frame>Next morning after polysomnography (8a.m.--4 p.m.)</time_frame>
    <description>number of errors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>One week previous to polysomnography</time_frame>
    <description>Monitoring of rest/activity cycles</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">58</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Good sleepers</arm_group_label>
    <description>COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bad sleepers</arm_group_label>
    <description>COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>polysomnography</intervention_name>
    <description>Monitoring of brain activity and respiratory variables during sleep</description>
    <arm_group_label>Bad sleepers</arm_group_label>
    <arm_group_label>Good sleepers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Actigraphy</intervention_name>
    <description>monitoring daily physical activity for 7 days</description>
    <arm_group_label>Bad sleepers</arm_group_label>
    <arm_group_label>Good sleepers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Osler test</intervention_name>
    <description>Evaluation of subjects´ ability to remain awake</description>
    <arm_group_label>Bad sleepers</arm_group_label>
    <arm_group_label>Good sleepers</arm_group_label>
    <other_name>Oxford sleep resistance test</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients aged 40-80 years, smokers or exsmokers of at least 10 pack-years,&#xD;
        diagnosed with moderate-to-severe COPD (post bronchodilator FEV1% &lt; 70% and FEV1 ≥ 30 but &lt;&#xD;
        80% of predicted in a spirometry performed within 6 months prior to inclusion into the&#xD;
        study)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Patients with written inform consent to participate in the study and all the following&#xD;
        criteria will be selected:&#xD;
&#xD;
          -  Age 40-80 years&#xD;
&#xD;
          -  Smokers or exsmokers of at least 10 pack-years&#xD;
&#xD;
          -  Moderate-to-severe COPD&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Non-stable COPD. Stability is defined as being exacerbation free and without treatment&#xD;
             changes for at least 4 weeks prior to baseline evaluation. The presence of a COPD&#xD;
             exacerbation previous to the sleep studies (polysomnography, actigraphy, OSLER test)&#xD;
             will lead to an early discontinuation of the patient´s participation in the study.&#xD;
&#xD;
          -  Heart failure, asthma, cancer or other major medical illness with known effects on&#xD;
             sleep quality.&#xD;
&#xD;
          -  Unable to understanding the questionnaires administered in the study.&#xD;
&#xD;
          -  Known Obstructive Sleep Apnea, other sleep disorder (narcolepsy, periodic limb&#xD;
             movements) or shift work.&#xD;
&#xD;
          -  Chronic respiratory failure (PaO2 &lt;60 mmHg).&#xD;
&#xD;
          -  Treatment with sedatives or antidepressants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Miravitlles, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vall d´Hebron Institut de Recerca</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gabriel Sampol, PhD</last_name>
    <phone>+34932746083</phone>
    <email>gsampol@vhebron.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jaume Ferrer, PhD</last_name>
    <phone>+34932746083</phone>
    <email>jjferrer@vhebron.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitari Vall d´Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriel Sampol, PhD</last_name>
      <phone>+34932746083</phone>
      <email>gsampol@vhebron.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Pokrzywinski RF, Meads DM, McKenna SP, Glendenning GA, Revicki DA. Development and psychometric assessment of the COPD and Asthma Sleep Impact Scale (CASIS). Health Qual Life Outcomes. 2009 Dec 7;7:98. doi: 10.1186/1477-7525-7-98.</citation>
    <PMID>19968881</PMID>
  </reference>
  <reference>
    <citation>Miravitlles M, Iriberri M, Barrueco M, Lleonart M, Villarrubia E, Galera J. Usefulness of the LCOPD, CAFS and CASIS scales in understanding the impact of COPD on patients. Respiration. 2013;86(3):190-200. doi: 10.1159/000341175. Epub 2012 Oct 2.</citation>
    <PMID>23037958</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 17, 2017</last_update_submitted>
  <last_update_submitted_qc>September 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 10, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03290014/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03290014
org study id: PR(AG)365/2015
nct id: NCT03290014
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Patients with COPD, in addition to daytime symptoms, may suffer from nocturnal disturbances.
      The frequency of nocturnal problems has been reported to be higher in COPD than in the
      general population and it currently affects up to 50% of patients.

      The CASIS questionnaire includes 7 questions and it has been recently validated as an
      objective tool to evaluate nocturnal symptoms in patients with asthma and COPD. The present
      study aims to study the validity of the CASIS questionnaire as a predictor of sleep quality
      measured by objective polysomnographic parameters.
observational model: Cohort
time perspective: Prospective
measure: Sleep efficiency
time frame: One night at the sleep unit
description: Sleep time/Time in bed
measure: Total sleep time
time frame: One night at the sleep unit
description: Total sleep time
measure: Arousal index
time frame: One night at the sleep unit
description: number of arousals/hour of sleep
measure: sleep architecture
time frame: One night at the sleep unit
description: percentage of the different sleep phases
measure: Osler test error index
time frame: Next morning after polysomnography (8a.m.--4 p.m.)
description: number of errors
measure: Actigraphy
time frame: One week previous to polysomnography
description: Monitoring of rest/activity cycles
arm group label: Good sleepers
description: COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
arm group label: Bad sleepers
description: COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
intervention type: Diagnostic Test
intervention name: polysomnography
description: Monitoring of brain activity and respiratory variables during sleep
arm group label: Bad sleepers
arm group label: Good sleepers
intervention type: Diagnostic Test
intervention name: Actigraphy
description: monitoring daily physical activity for 7 days
arm group label: Bad sleepers
arm group label: Good sleepers
intervention type: Diagnostic Test
intervention name: Osler test
description: Evaluation of subjects´ ability to remain awake
arm group label: Bad sleepers
arm group label: Good sleepers
other name: Oxford sleep resistance test
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Marc Miravitlles, PhD
role: Study Chair
affiliation: Vall d´Hebron Institut de Recerca
last name: Gabriel Sampol, PhD
phone: +34932746083
email: gsampol@vhebron.net
last name: Jaume Ferrer, PhD
phone: +34932746083
email: jjferrer@vhebron.net
facility: 
status: Recruiting
contact: 
country: Spain
citation: Pokrzywinski RF, Meads DM, McKenna SP, Glendenning GA, Revicki DA. Development and psychometric assessment of the COPD and Asthma Sleep Impact Scale (CASIS). Health Qual Life Outcomes. 2009 Dec 7;7:98. doi: 10.1186/1477-7525-7-98.
PMID: 19968881
citation: Miravitlles M, Iriberri M, Barrueco M, Lleonart M, Villarrubia E, Galera J. Usefulness of the LCOPD, CAFS and CASIS scales in understanding the impact of COPD on patients. Respiration. 2013;86(3):190-200. doi: 10.1159/000341175. Epub 2012 Oct 2.
PMID: 23037958
responsible party type: Sponsor
provided document: 