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

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ClinicalTrials.gov Identifier: NCT00295386
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : January 6, 2009
Information provided by:
University of Bergen

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
Insomnia Behavioral: Cognitive behavior therapy (CBT) Drug: Zopiclone Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : January 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : December 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00295386

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University of Bergen
Bergen, Norway, 5020
Sponsors and Collaborators
University of Bergen
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Study Director: Inger H Nordhus, PhD University of Bergen
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00295386    
Other Study ID Numbers: REK Vest nr. 186.03
First Posted: February 23, 2006    Key Record Dates
Last Update Posted: January 6, 2009
Last Verified: January 2009
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs