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

Completed · Phase 2

Conditions studied: Insomnia Disorder

In brief

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

Key facts

Study ID

NCT03056053

Run by

Idorsia Pharmaceuticals Ltd.

People needed

113

Starts

2017-02-15

Expected to finish

2017-05-05

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Santa Monica Clinical Trials — Santa Monica, California, United States
• Neurotrials Research Inc — Atlanta, Georgia, United States
• Clinical Research CTR of Nevada — Las Vegas, Nevada, United States
• Clinilabs NYC — New York, New York, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• St-Hedwig Krankenhaus, Schlaflab — Berlin, Germany
• Advanced Sleep Research Berlin — Berlin, Germany
• CTC North, Universitätsklinikum Hamburg- Eppendorf — Hamburg, Germany
• Somnibene Inst Med Forschung & Schlafmedizin — Schwerin, Germany

Full record on ClinicalTrials.gov

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