ACTRN12622000158763Recruiting未知
Australian Research on Insomnia, Stress & Emotions (ARISE): Examining the role of rapid eye movement (REM) sleep in trauma recovery mechanisms in Insomnia patients.
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Monash University
- Enrollment
- 92
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (—)
- Sex
- All
Inclusion Criteria
- •a) Insomnia Disorder
- •b) 18-70 years of age
- •c) Fluent in English
- •d) Full vaccination status (COVID-19)
Exclusion Criteria
- •a) Unmanaged sleep disorders other than insomnia and extreme chronotypes
- •b) History of night or early morning shift work in the past 3 months or transmeridian travel (greater or equal to 2 time zones) in the past 2 months
- •c) Current behavioural treatment for insomnia (or within past month)
- •d) Major mental health condition(s) known to affect REM sleep or fear inhibition
- •e) Major physical health condition(s)
- •f) Current Substance Use Disorder (including Alcohol Abuse), frequent cannabis use or other recreational drug use
- •g) Current use or recent discontinuation of medications known to affect REM sleep or fear inhibition. These include, SSRIs/SNRIs, tricyclic antidepressants, opiates, orexin antagonists, benzodiazepines, hypnotics, corticosteroids and ADHD medication (methylphenidate, amphetamine etc). Participants may be eligible to participate if the drug has been safely discontinued for a minimum duration equivalent to 5 half-lives of the drug.
- •h) Failure to exhibit a consistent startle response on day of screening (i.e., over 75% discernible response to six 108-dB 20ms startle pulses), as a normal startle response is necessary to measure fear inhibition via the fear potentiated startle task we will use.
- •i) Failure to respond to a 35 dB pulse at 500, 1000 and 3000 Hz in both ears when tested via an audiometer.
- •j) Age above 70 years, as this group has been shown to exhibit diminished startle responses and fear conditioning rates. Normal startle responding and fear conditioning rates are required for the paradigm used to test one of the main outcomes of interest (i.e., fear and safety recall in the fear-potentiated startle task).
- •k) Living with a children under 1 year of age, as they impact sleep.
- •l) Currently pregnant or breastfeeding, or actively trying to conceive. Major changes in sex hormones during these stages are likely to affect fear conditioning and extinction measures.
- •m) Any current treatments involving sex hormones (e.g., gender-affirming hormone treatments, fertility treatments), with the exception of birth control and hormone replacement therapies (e.g., estrogen replacement therapy in peri/postmenopausal women) if the participant has been on a stable dose for at least 3 months. If the participant has just come off hormone replacement therapy, a period of 3 months for hormones to re-stabilise is required before study participation.
- •n) Hot flashes which are frequent or cause significant interference with sleep
- •o) Any other factor that the researcher determines will affect study outcome.
- •In-treatment exclusions:
- •a) Hospitalisation
- •b) Taking >10 weeks to complete the 7-week treatment program.
Investigators
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