InsomniaPhase 4NCT00295386
Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
A Phase 4 study testing Cognitive behavior therapy (CBT) and Zopiclone in people with Insomnia, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive behavior therapy (CBT) and Zopiclone
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteNorway
- Study dates
- Jan 2004to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Insomnia
- Being tested
- Cognitive behavior therapy (CBT), Zopiclone
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavior therapy (CBT)Behavioural
ZopicloneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startJan 2004
- Primary completionJan 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Investigators
- Inger H Nordhus, PhD, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295386
- Sponsor's protocol ID
- REK Vest nr. 186.03
- Status last verified
- Jan 2009
- First submitted
- 21 Feb 2006
- Last updated
- 6 Jan 2009
- Results posted
- No
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. doi: 10.1001/jama.295.24.2851.
PubMed 16804151Omvik 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.
PubMed 18417099Sivertsen 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.
PubMed 17068990
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly
- ClinicalTrials.gov ID
- NCT00295386
- Acronym / sponsor ID
- REK Vest nr. 186.03
- Conditions
- Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 23 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavior therapy (CBT) | Behavioural | – |
| Zopiclone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2009.
- Results publication: PubMed 16804151Sivertsen 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.
- Results publication: PubMed 18417099Omvik 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.
- Results publication: PubMed 17068990Sivertsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inger H Nordhus, PhD study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive behavior therapy (CBT) and Zopiclone in people with Insomnia, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00295386, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2009.