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

Sponsor
Idorsia Pharmaceuticals Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03056053
Collaborator
(none)
113
Enrollment
9
Locations
1
Arm
2.6
Actual Duration (Months)
12.6
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
113 participants
Allocation:
N/A
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 :
Feb 15, 2017
Actual Primary Completion Date :
Apr 21, 2017
Actual Study Completion Date :
May 5, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Content validity of the IDSIQ™: scoring of items into domains [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 [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 [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 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Santa Monica Clinical Trials Santa Monica California United States 90404
    2 Neurotrials Research Inc Atlanta Georgia United States 30342
    3 Clinical Research CTR of Nevada Las Vegas Nevada United States 89104
    4 Clinilabs NYC New York New York United States 10019
    5 CTI Clinical Research Center Cincinnati Ohio United States 45255
    6 St-Hedwig Krankenhaus, Schlaflab Berlin Germany 10115
    7 Advanced Sleep Research Berlin Berlin Germany 10117
    8 CTC North, Universitätsklinikum Hamburg- Eppendorf Hamburg Germany 20251
    9 Somnibene Inst Med Forschung & Schlafmedizin Schwerin Germany 19053

    Sponsors and Collaborators

    • Idorsia Pharmaceuticals Ltd.

    Investigators

    • Study Director: Sara Mangialaio, MD, Actelion

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Idorsia Pharmaceuticals Ltd.
    ClinicalTrials.gov Identifier:
    NCT03056053
    Other Study ID Numbers:
    • AC-078A203
    First Posted:
    Feb 17, 2017
    Last Update Posted:
    Jul 24, 2019
    Last Verified:
    Jul 1, 2019
    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:
    Sleep Initiation and Maintenance Disorders
    Zolpidem

    Study Results

    No Results Posted as of Jul 24, 2019