Evaluating a portable device to advance the internal body clock to treat insomnia

Not Applicable

• Conditions: Chronic Insomnia Disorder; Sleep Onset Insomnia; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12619000950167
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-05
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Symptoms that meet the criteria for a diagnosis of insomnia, according to the ICSD-3. Specifically;
1. Sleep diary data which indicates difficulties initiating sleep (>30-minute latency to sleep) at least three times in the one-week screening assessment period.
2. Sleep and daytime functioning questionnaire scores which indicate insomnia:
oInsomnia Severity Index >10

Exclusion Criteria

a)Taking any medication that would affect sleep/melatonin production
b)Had recent eye surgery or a chronic eye condition,
c)Difficulties with the English language that would prevent informed consent,
d)Receiving other forms of sleep treatment,
e)Diagnosis of sleep disorder other than insomnia,
f)Were habitual high consumers of caffeine (greater than or equal to 250 mg daily) and/or alcohol (greater than or equal to 14 standard drinks per week),
g)Indicated a history of substance abuse in the last 12 months,
h)Worked a night shift in the previous 2 months (night shift was defined as a work schedule including at least 6 h of work between 10:00 p.m. And 8:00 a.m.),
i)Undertook trans-meridian travel (two time zones) in the last 2 months,
j)Pregnant or lactating, or
k)Clinically diagnosed depression.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase advance of the circadian rhythm as measured by Dim Light Melatonin Onset via saliva samples[Days 2 and 8 of treatment week];Sleep onset latency as measured by sleep diaries and Actigraphy[Mean days 1-7 pre-treatment, mean days 1-7 post-treatment (primary endpoint), and mean days 1-7 follow-up (follow-up begins one week after treatment week ends)]

Secondary Outcome Measures

Name	Time	Method
ight-time sleepiness as measured the Stanford Sleepiness Scale[Days 2 and 8 of treatment week];Insomnia symptoms as measured by the Insomnia Severity Scale[Mean days 1-7 pre-treatment, mean days 1-7 post-treatment, and mean days 1-7 follow-up]