<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/NCT02183714</url>
  </required_header>
  <id_info>
    <org_study_id>582.1</org_study_id>
    <nct_id>NCT02183714</nct_id>
  </id_info>
  <brief_title>The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances</brief_title>
  <official_title>The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to&#xD;
      placebo in patients with mild to moderate insomnia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 1998</start_date>
  <primary_completion_date type="Actual">December 1998</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in sleep quality on a 100 mm visual analogue scale (VAS)</measure>
    <time_frame>baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feeling refreshed score (six point rating scale)</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to concentrate and perform well score (six point rating scale)</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Night-time total sleeping time</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty in falling asleep (five point rating scale)</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of awakenings during the night</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical and mental health state by short form (SF-36) questionnaire</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety by State-Trait Anxiety Inventory</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global clinical impression on insomnia by short questionnaire</measure>
    <time_frame>up to week 5</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <arm_group>
    <arm_group_label>Songha Night ®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Songha Night ®</intervention_name>
    <arm_group_label>Songha Night ®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Psychophysiologic insomnia&#xD;
&#xD;
          -  Severity: mild to moderate&#xD;
&#xD;
          -  Duration: subacute to chronic&#xD;
&#xD;
          -  Subjects age &gt; 18 and &lt; 65, men or women&#xD;
&#xD;
          -  Subject had to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Regular use of psycho-active drugs&#xD;
&#xD;
          -  Work in shifts&#xD;
&#xD;
          -  Use of psychoactive drugs during the past 30 days&#xD;
&#xD;
          -  Any treatment that might interfere with his/her participation in this study and the&#xD;
             evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency,&#xD;
             hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder,&#xD;
             myasthenia gravis, delirious state, etc.)&#xD;
&#xD;
          -  known hypersensitivity to any of the ingredients of the study drug&#xD;
&#xD;
          -  Pregnancy, lactation, women of childbearing potential not using an established&#xD;
             contraceptive&#xD;
&#xD;
          -  Drug and alcohol abuse&#xD;
&#xD;
          -  Participation in another trial within the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/582/582.1_U00-0003.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 7, 2014</last_update_submitted>
  <last_update_submitted_qc>July 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</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>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02183714
org study id: 582.1
nct id: NCT02183714
lead sponsor: 
To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to
      placebo in patients with mild to moderate insomnia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Change in sleep quality on a 100 mm visual analogue scale (VAS)
time frame: baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment
measure: Feeling refreshed score (six point rating scale)
time frame: up to week 5
measure: Ability to concentrate and perform well score (six point rating scale)
time frame: up to week 5
measure: Night-time total sleeping time
time frame: up to week 5
measure: Difficulty in falling asleep (five point rating scale)
time frame: up to week 5
measure: Number of awakenings during the night
time frame: up to week 5
measure: Physical and mental health state by short form (SF-36) questionnaire
time frame: up to week 5
measure: Anxiety by State-Trait Anxiety Inventory
time frame: up to week 5
measure: Frequency of adverse events
time frame: up to week 5
measure: Global clinical impression on insomnia by short questionnaire
time frame: up to week 5
arm group label: Songha Night ®
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Songha Night ®
arm group label: Songha Night ®
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/582/582.1_U00-0003.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Sleep Initiation and Maintenance Disorders