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

NCT00295386 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2009-01-06

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Cognitive behavior therapy (CBT)

DRUG

Zopiclone

Sponsors & Collaborators

  • University of Bergen

    lead OTHER

Principal Investigators

  • Inger H Nordhus, PhD · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2006-01-31
Completion
2007-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00295386 on ClinicalTrials.gov