Sleep restriction for the treatment of primary insomnia in primary care
Not Applicable
Completed
- Conditions
- Primary InsomniaOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12609000127202
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Age 16-75, Primary insomnia lasting greater than 6 months, able to understand English
Exclusion Criteria
Presence of alternate sleep disorder, major medical or psychiatric illness, medically unstable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep Quality a) Subjective as measured by Pittsburgh Sleep Quality Index (PSQI) and by the Insomnia Severity Index (ISI) b) Objective as measured by Sleep efficiency (SE), total sleep time (TST), sleep onset latency (SOL) and wake after sleep onset (WASO) - derived from sleep diary and actigraphic data. <br>At 3 months diagnostic crietria for insomnia, PSQI and ISI assessed using mail out. At 6 months these measures are repeated along with a two week collection of sleep diary and actigraphy data.[3 months, 6 months]
- Secondary Outcome Measures
Name Time Method Sleepiness - measured using the Epworth Sleepiness Score[6 months];Mood<br>a) Depression - as measured by the -item Patient Health QUestionniare (PHQ-9)<br>b) Anxiety - as measured by the 7-item Generalised Anxiety Disorder Scale (GAD-7)[6 months];Fatigue - measured using the Flinders Fatigue Score[6 months];Adverse events:<br>a) incidence of acute coronary syndrome and cerebrovascular events<br>b) Hospital admissions<br>c) Accidents (minor/major-requiring medical attention)<br>d) change in resting heart rate and blood pressure[Week 3, 6 months]