NCT03056053

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

Multi-center, Single-arm, Open-label Study in Patients With Insomnia Disorder to Validate the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
DRUG	Zolpidem	Commercially available tablets of zolpidem (5 or 10 mg) for oral use

Timeline

• Start date: 2017-02-15
• Primary completion: 2017-04-21
• Completion: 2017-05-05
• First posted: 2017-02-17
• Last updated: 2019-07-24

Locations

9 sites across 2 countries: United States, Germany