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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

February 21, 2006
February 23, 2006
January 6, 2009
January 2004
January 2006   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00295386 on ClinicalTrials.gov Archive Site
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Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
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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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Behavioral: Cognitive behavior therapy (CBT)
  • Drug: Zopiclone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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December 2007
January 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
REK Vest nr. 186.03
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University of Bergen
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Study Director: Inger H Nordhus, PhD University of Bergen
University of Bergen
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP