Ignite Creation Date:
2024-05-06 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03056053
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2017-01-31
Brief Title:
Study to Validate the Questionnaire Called IDSIQ in Patients With Insomnia Disorder
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
Official Title:
Multi-center Single-arm Open-label Study in Patients With Insomnia Disorder to Validate the Insomnia Daytime Symptoms and Impacts Questionnaire IDSIQ
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None