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Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder

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ClinicalTrials.gov Identifier: NCT03056053
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Idorsia Pharmaceuticals Ltd.

Brief Summary:
The main study objective is to assess the content validity and the psychometric characteristics of the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™).

Condition or disease Intervention/treatment Phase
Insomnia Disorder Drug: Zolpidem Phase 2

Detailed Description:

Zolpidem will be used as an active intervention to assess the sensitivity to change of IDSIQ™ in patients suffering from insomnia disorder.

IDSIQ™ will be administered during the screening period (within 14 days before enrollment in the study) and the treatment period (from Day 1 to Day 14). End of study (phone call) will take place 30-37 days after the end-of-treatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multi-center, Single-arm, Open-label Study in Patients With Insomnia Disorder to Validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : April 21, 2017
Actual Study Completion Date : May 5, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Zolpidem
Commercially available zolpidem (5 or 10 mg) will be administered orally once daily during the treatment period (Day 1 to Day 14) following prescribing information from each country participating in this study
Drug: Zolpidem
Commercially available tablets of zolpidem (5 or 10 mg) for oral use
Other Names:
  • Ambien
  • Zolpidem generics
  • Stilnox




Primary Outcome Measures :
  1. Content validity of the IDSIQ™: scoring of items into domains [ Time Frame: During the screening period, i.e. within 14 days before Day 1 ]
    Content validity will be based on the combination of qualitative and statistical methods in order to generate a scoring algorithm


Secondary Outcome Measures :
  1. Psychometric validitiy of the IDSIQ™: Internal reliability [ Time Frame: During the screening period, i.e. within 14 days before Day 1 ]
    Internal consistency reliability assesses the extent to which the items correlate which each other within their domain and it is evaluated by correlation scores

  2. Psychometric validitiy of the IDSIQ™: Test-retest reliability [ Time Frame: During the screening period, i.e. within 14 days before Day 1 ]
    Test-retest reliability assesses the reproducibility of the domain scores during a specific time period of stable condition and it is evaluated by intraclass correlation coefficients

  3. Psychometric validitiy of the IDSIQ™: sensitivity to change [ Time Frame: At Week 1 and Week 2 ]
    Changes in the IDSIQ domain scores after 2 weeks of treatment with zolpidem compared to baseline (before zolpidem administration)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure;
  • Male or female aged ≥ 18 years;
  • Body mass index (BMI): 18.5 ≤ BMI (kg/m2) < 32.0;
  • Insomnia disorder according to DSM-5 criteria;
  • Insufficient sleep quantity evaluated according to the self-reported history and data collected in the sleep diary;
  • Insomnia Severity Index score greater than or equal to 15;
  • Complete the IDSIQ™ and the sleep diary questionnaire as required.

Exclusion Criteria:

  • Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement behavior disorder, or narcolepsy;
  • Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week;
  • Caffeine consumption ≥ 600 mg per day;
  • Shift work within 2 weeks prior to the screening visit, or planned shift work from V1 to V3;
  • Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel ≥ 3 time zones from V1 to V3;
  • Known severe renal impairment or know moderate or severe hepatic impairment;
  • History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments;
  • Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056053


Locations
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United States, California
Santa Monica Clinical Trials
Santa Monica, California, United States, 90404
United States, Georgia
Neurotrials Research Inc
Atlanta, Georgia, United States, 30342
United States, Nevada
Clinical Research CTR of Nevada
Las Vegas, Nevada, United States, 89104
United States, New York
Clinilabs NYC
New York, New York, United States, 10019
United States, Ohio
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45255
Germany
St-Hedwig Krankenhaus, Schlaflab
Berlin, Germany, 10115
Advanced Sleep Research Berlin
Berlin, Germany, 10117
CTC North, Universitätsklinikum Hamburg- Eppendorf
Hamburg, Germany, 20251
Somnibene Inst Med Forschung & Schlafmedizin
Schwerin, Germany, 19053
Sponsors and Collaborators
Idorsia Pharmaceuticals Ltd.
Investigators
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Study Director: Sara Mangialaio, MD Actelion

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Responsible Party: Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT03056053     History of Changes
Other Study ID Numbers: AC-078A203
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Idorsia Pharmaceuticals Ltd.:
insomnia
Additional relevant MeSH terms:
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Zolpidem
GABA-A Receptor Agonists
GABA Agonists
Sleep Initiation and Maintenance Disorders
Disease
Pathologic Processes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action