drugset / Trial / NCT00295386

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

NCT00295386

Phase 4 Completed University of Bergen
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Zopiclone Small molecule 7.5 mg

Indications