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Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly

Sponsor
University of Bergen (Other)
Overall Status
Completed
CT.gov ID
NCT00295386
Collaborator
(none)
1
Location
47
Duration (Months)

Study Details

Study Description

Brief Summary

The present study examines the short- and long-term clinical efficacy of cognitive-behavior therapy and pharmacological treatment in patients suffering from late-life primary insomnia. 46 subjects suffering from chronic primary insomnia were randomized into either cognitive-behavior therapy (CBT, n=18), hypnotics (7.5 mg Zopiclone, n=16), or placebo treatment (n=12). All active treatments lasted 6 weeks with follow-ups conducted at 6 months. Ambulant clinical polysomnography (PSG) and sleep diaries were used on all three assessment points.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Jan 1, 2006
Actual Study Completion Date :
Dec 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age 55 years or older

    • fulfilment of the DMS-IV criteria for insomnia, including difficulties initiating sleep, maintaining sleep, and/or early morning awakenings with no ability of return to sleep

    • duration of at least 3 months

    • complaints of impaired daytime functioning.

    Exclusion Criteria:

    • use of hypnotic medication the last 4 weeks before project start

    • use of antidepressive or antipsychotic medications

    • signs of dementia or other serious cognitive impairment defined by a score under 25 on the Mini-Mental State Examination

    • presence of a major depressive disorder or other severe mental disorder as identified by a clinical assessment based on The Structured Clinical Interview for DSM-IV (SCID-I)

    • presence of sleep apnea defined as (A/H index > 15) or periodic limb movements during sleep (PLM index with arousal > 15),

    • working nightshifts and unable or unwilling to discontinue this work pattern,

    • willingness or inability to stop taking sleep medication before start

    • having a serious somatic conditions preventing further participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Bergen Bergen Norway 5020

    Sponsors and Collaborators

    • University of Bergen

    Investigators

    • Study Director: Inger H Nordhus, PhD, University of Bergen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00295386
    Other Study ID Numbers:
    • REK Vest nr. 186.03
    First Posted:
    Feb 23, 2006
    Last Update Posted:
    Jan 6, 2009
    Last Verified:
    Jan 1, 2009
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Zopiclone

    Study Results

    No Results Posted as of Jan 6, 2009