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

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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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Bergen

Bergen, 5020, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavior therapy (CBT)

Behavioral

Zopiclone

Drug

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2007
First posted: Feb 23, 2006
Registry last updated: Jan 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed