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

Insomnia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295386
• Other study ID #: REK Vest nr. 186.03
• Status: Completed
• Phase: Phase 4
• First received: February 21, 2006
• Last updated: January 2, 2009
• Start date: January 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2009
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2007
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Cognitive behavior therapy (CBT)

Drug:
• Zopiclone

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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- — View 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. — View 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. — View Citation