Can enhanced insomnia phenotyping aid prediction of treatment response?

Not Applicable

Completed

• Conditions: Insomnia Disorder; Mental Health; Mental Health - Other mental health disorders

• Registration Number: ACTRN12615000751572
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

1. Symptoms of Insomnia Disorder as diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for insomnia disorder (APA, 2013) specifically: Difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty.
2. Insomnia Severity Index score more than or equal to 10
3. Fluent speaker of English
4. Aged >18 years
5. Stable sleep/wake schedule (habitual bedtime 22:00-00:00 +/- 2 hours)
6. Able to give informed, written consent

Exclusion Criteria

1. Pregnancy or lactation
2. Active illicit substance use or alcohol/caffeine dependence
3. Medications that interfere with sleep (within 1 month of assessment)
4. Psychiatric disorders, other than mild to moderate depression (on the
Depression Anxiety Stress Scales)
5. Another sleep disorder evaluated by a Sleep Physician / Sleep Psychologist that better explains the complaint of sleep loss.
6. Severe cognitive impairment that does not allow patients to consent or follow study instructions
7. Overnight shift workers and recent time-zone travel (within last 2 months)
8. Actively treated sleep disorder (e.g. CPAP/CBT-I)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index[At Week 17 compared to Week 0.];Sleep Diary Defined Sleep Onset Latency[Average of Weeks 17 & 18 compared to Average of Weeks -2 & -1.];Sleep Diary Defined Wake-time After Sleep Onset[Average of Weeks 17 & 18 compared to Average of Weeks -2 & -1.]