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Insomnia 100 sleep study: Profiling of Insomnia disorder in a sample of 100 participants

Profiling of Insomnia disorder in a sample of 100 participants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612000049875
Enrollment
100
Registered
2012-01-11
Start date
2012-02-29
Completion date
2014-08-02
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To discover and profile the biological mechanisms within Insomnia. This will be achieved by sampling a large number of sufferers and examining them overnight through a clinical sleep study.

Interventions

This study consists of two visits to the Woolcock institute. One for screening / consent lasting an hour where the participants will be given an actiwatch and sleep diary to complete for two weeks. After this period, the participant will attend an overnight routine sleep assessment again at the Woolcock institute this will last no longer than 12 hours. After this the study will end. Actiwatch and Diaries. The actiwatch looks like a conventional wrist watch and is used to objectively assess sleep

This study consists of two visits to the Woolcock institute. One for screening / consent lasting an hour where the participants will be given an actiwatch and sleep diary to complete for two weeks. After this period, the participant will attend an overnight routine sleep assessment again at the Woolcock institute this will last no longer than 12 hours. After this the study will end. Actiwatch and Diaries. The actiwatch looks like a conventional wrist watch and is used to objectively assess sleep and wake activity, while the diaries contain questions relating to sleep quality, subjective sleepiness and drug accountability. Both are to be used by the patient at home for one week prior to the routine overnight visit. Questionnaires. These will be used at each visit to assess subjective sleepiness, quality of sleep, quality of life, depression and investigator’s overall impression of the status of the patient. These will take approximately 45 min to complete. Routine Diagnostic Polysomnographic Sleep Study. The patient will spend a night in the sleep laboratory at the Woolcock Institute for Medical Research for a routine diagnostic sleep study. This will determine the status of their sleep in general and if they suffer from any potential comorbid conditions. A small amount of blood will be taken as well to check liver function and a full blood count. This will take twelve hours. Neurocognitive test battery. A computer based battery of tests will be administered during the routine overnight sleep study. This will consist of short tests assessing attention & cognitive function. All together, these tests will take approximately one hour. After the study, participants with insomnia will be offered to complete a course in cognitive behavioural therapy for insomnia (CBT-I) as a thank you for completing the study. They will have the choice of internet based CBT-I with six online sessions to address worries and anxieties about sleeping, relaxation techniques, sleep hygiene procedures, and sleep scheduling involving stimulus control and sleep restriction therapy. Each session will take approximately an hour to complete over six weeks. The website is completely interactive and moderated by a team of psychologists. Alternatively, participants may enroll into a insomnia CBT-I workshop with a psychologist that also involves 5 hour long sessions (1 hour per session over 10 weeks) to address worries and anxieties about sleeping, relaxation techniques, sleep hygiene procedures, and sleep scheduling involving stimulus control and sleep restriction therapy for insomnia. At the end of both interventions, participants will have their insomnia severity index score re-examined.

Sponsors

University of Sydney
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

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 2. Stable sleep/wake schedule with no shift work 3. Able to give informed, written consent 4. Fluent speaker of English 5. Referred by a sleep physician to have a routine sleep study as part of Medicare

Exclusion criteria

1. Active illicit substance use or alcohol dependence 2. Psychiatric disorders, other than mild to moderate depression (on the Depression Anxiety Stress Scales) 3. Previous history of depressive episode 4. Sleep disorders (other than insomnia) 5. Learning disabilities 6. Dementia 7. Neurological problems 8. Pregnancy or lactation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026