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

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Zopiclone

U.S. FDA Resources

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:

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 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Zopiclone
Nervous System Diseases
Physiological Effects of Drugs
Dyssomnias
Sleep Disorders
Central Nervous System Depressants

Pharmacologic Actions
Sleep Disorders, Intrinsic
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009