Clinical trial NCT00295386: Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2006-02-23
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
affiliation: University of Bergen
name: Inger H Nordhus, PhD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1001/jama.295.24.2851.
citation: 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. doi: 10.1016/j.brat.2008.02.013.
citation: 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;29(10):1353-8. doi: 10.1093/sleep/29.10.1353.