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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2017-05-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Insomnia Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Zolpidem

Intervention Type DRUG

Commercially available tablets of zolpidem (5 or 10 mg) for oral use

Interventions

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Zolpidem

Commercially available tablets of zolpidem (5 or 10 mg) for oral use

Intervention Type DRUG

Other Intervention Names

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Ambien Zolpidem generics Stilnox

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No