Back to resultsCognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavior therapy (CBT)
Zopiclone
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
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
Sites / Locations
- University of Bergen
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00295386
First Posted
February 21, 2006
Last Updated
January 2, 2009
Sponsor
University of Bergen
1. Study Identification
Unique Protocol Identification Number
NCT00295386
Brief Title
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bergen
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy (CBT)
Intervention Type
Drug
Intervention Name(s)
Zopiclone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inger H Nordhus, PhD
Organizational Affiliation
University of Bergen
Official's Role
Study Director
Facility Information:
Facility Name
University of Bergen
City
Bergen
ZIP/Postal Code
5020
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
16804151
Citation
Sivertsen B, Omvik S, Pallesen S, Bjorvatn B, Havik OE, Kvale G, Nielsen GH, Nordhus IH. Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial. JAMA. 2006 Jun 28;295(24):2851-8. doi: 10.1001/jama.295.24.2851.
Results Reference
result
PubMed Identifier
18417099
Citation
Omvik S, Sivertsen B, Pallesen S, Bjorvatn B, Havik OE, Nordhus IH. Daytime functioning in older patients suffering from chronic insomnia: treatment outcome in a randomized controlled trial comparing CBT with Zopiclone. Behav Res Ther. 2008 May;46(5):623-41. doi: 10.1016/j.brat.2008.02.013.
Results Reference
result
PubMed Identifier
17068990
Citation
Sivertsen B, Omvik S, Havik OE, Pallesen S, Bjorvatn B, Nielsen GH, Straume S, Nordhus IH. A comparison of actigraphy and polysomnography in older adults treated for chronic primary insomnia. Sleep. 2006 Oct;29(10):1353-8. doi: 10.1093/sleep/29.10.1353.
Results Reference
result
Learn more about this trial
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
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