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

Sponsored by:	University of Bergen
Information provided by:	University of Bergen
ClinicalTrials.gov Identifier:	NCT00295386

Purpose

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

Drug Information available for: Zopiclone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further study details as provided by University of Bergen:

Study Start Date:	January 2004
Study Completion Date:	December 2007
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295386

Locations

Norway
University of Bergen
Bergen, Norway, 5020

Sponsors and Collaborators

University of Bergen

Investigators

Study Director:

Inger H Nordhus, PhD

University of Bergen

More Information

Publications of Results:

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.

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.

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 1;29(10):1353-8.

Study ID Numbers:	REK Vest nr. 186.03
Study First Received:	February 21, 2006
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00295386
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Zopiclone

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Hypnotics and Sedatives

Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009