Pharmacological and Behavioral Treatment of Insomnia
Primary Purpose
Lung Diseases, Sleep, Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Lung Diseases
Eligibility Criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005753
First Posted
May 25, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005753
Brief Title
Pharmacological and Behavioral Treatment of Insomnia
Study Type
Observational
2. Study Status
Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
June 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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 pharmacological/behavioral 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Sleep, Sleep Initiation and Maintenance Disorders
7. Study Design
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg Jacobs
Organizational Affiliation
Beth Israel Deaconess Medical Center
12. IPD Sharing Statement
Citations:
PubMed Identifier
15451764
Citation
Jacobs GD, Pace-Schott EF, Stickgold R, Otto MW. Cognitive behavior therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison. Arch Intern Med. 2004 Sep 27;164(17):1888-96. doi: 10.1001/archinte.164.17.1888.
Results Reference
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Learn more about this trial
Pharmacological and Behavioral Treatment of Insomnia
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