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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lung Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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    Pharmacological and Behavioral Treatment of Insomnia

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