Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005753
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Pharmacological and Behavioral Treatment of Insomnia
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-02
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:
to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to reduce its impact on psychological functioning health and economic sequelae
Detailed Description:
DESIGN NARRATIVE
The study examined the relative efficacy of a pharmacologic cognitive behavioral and conjoint pharmacologicalbehavioral intervention for chronic sleep-onset insomnia Sixty-three medication-free chronic sleep-onset insomniacs completed evaluations baseline sleep diaries daytime functioning and mood inventories and home-based objective sleep assessments OSA Subjects were then randomized to one of four interventions 1 six week Zolpidem intervention D for drug 2 six week multifactor behavioral intervention B for behavioral 3 six week conjoint Zolpidem and multifactor behavioral intervention DB and 4 placebo medication intervention P for placebo The main outcome measures were sleep-onset latency as measured by sleep diaries secondary measures included sleep diary measures of sleep efficiency and total sleep time objective measures of sleep variables Nightcap sleep monitor recorder and measures of daytime functioning
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
The study examined the relative efficacy of a pharmacologic cognitive behavioral and conjoint pharmacologicalbehavioral intervention for chronic sleep-onset insomnia Sixty-three medication-free chronic sleep-onset insomniacs completed evaluations baseline sleep diaries daytime functioning and mood inventories and home-based objective sleep assessments OSA Subjects were then randomized to one of four interventions 1 six week Zolpidem intervention D for drug 2 six week multifactor behavioral intervention B for behavioral 3 six week conjoint Zolpidem and multifactor behavioral intervention DB and 4 placebo medication intervention P for placebo The main outcome measures were sleep-onset latency as measured by sleep diaries secondary measures included sleep diary measures of sleep efficiency and total sleep time objective measures of sleep variables Nightcap sleep monitor recorder and measures of daytime functioning
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R29HL059387 | NIH | None | httpsreporternihgovquickSearchR29HL059387 |