Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044629
Status:
COMPLETED
Last Update Posted:
2013-09-16
First Post:
2002-09-03
Brief Title:
Combined BehavioralPharmacological Therapy for Insomnia
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Combined BehavioralPharmacological Therapy for Insomnia
Status:
COMPLETED
Status Verified Date:
2013-09
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:
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia
Detailed Description:
Long-term insomnia is a common and significant health problem Two main treatments pharmacotherapy and behavioral therapy have been used to help people with insomnia Because both treatments have advantages and disadvantages a combination of these treatments may be a good way to treat insomnia
During the first 2 weeks of the study participants keep a sleep log wear an actigraph a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake and complete questionnaires
Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate Ambien behavioral therapy plus placebo or behavioral therapy alone During treatment participants return to the clinic once a week to turn in their sleep logs download their actigraph and complete questionnaires
After 6 weeks participants enter the post-treatment phase of the study which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study
After the post-treatment phase participants enter the follow-up period and are contacted at 3 months 6 months and 1 year to complete another 2-week assessment with sleep logs actigraphy and questionnaires
During the first 2 weeks of the study participants keep a sleep log wear an actigraph a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake and complete questionnaires
Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate Ambien behavioral therapy plus placebo or behavioral therapy alone During treatment participants return to the clinic once a week to turn in their sleep logs download their actigraph and complete questionnaires
After 6 weeks participants enter the post-treatment phase of the study which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study
After the post-treatment phase participants enter the follow-up period and are contacted at 3 months 6 months and 1 year to complete another 2-week assessment with sleep logs actigraphy and questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 83-ATAS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH062119 |
| R01MH062119 | NIH | None | None |