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Trial registered on ANZCTR


Registration number
ACTRN12619000850178
Ethics application status
Approved
Date submitted
30/05/2019
Date registered
17/06/2019
Date last updated
17/06/2019
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating insomnia symptoms using the THIM sleep tracking device.
Scientific title
A clinical trial of the efficacy of THIM-administered Intensive Sleep Re-training for treating chronic insomnia symptoms.
Secondary ID [1] 298375 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insomnia 313046 0
Condition category
Condition code
Mental Health 311544 311544 0 0
Other mental health disorders
Neurological 311628 311628 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this clinical trial is THIM-administered Intensive Sleep Retraining. This behavioural treatment protocol requires the patient to fall asleep and be woken up shortly after sleep onset on multiple occasions over the course of one four-hour treatment session. This treatment will occur in the patient's home environment beginning around their typical bedtime. THIM is a small, light-weight device worn on the index finger of the dominant hand like a ring. It is calibrated using an accompanying smartphone application via Bluetooth, which is also used to retrieve the data. THIM will administer Intensive Sleep Retraining by detecting when the patient has fallen asleep and promptly waking them up with a high intensity alarm vibration. Participants will be instructed to wake up at their typical wake up time following the Intensive Sleep Retraining session. Sleep hygiene instructions will also be provided in paper form by the principle researcher, including typical instructions about maintaining a consistent sleep schedule, limiting caffeine intake in the afternoon, and creating a relaxing bedroom environment. Adherence will be monitored via THIM data linkage, participant sleep diary, and data from a watch-like actigraphy device (measures movement to estimate sleep and wakefulness) to be worn on the wrist throughout data collection.
On the intervention night, both the intervention and control group will undergo ambulatory polysomnography (PSG) recording to objectively measure physiological changes associated with sleep (brain waves, etc.). This will provide an additional measure of treatment adherence. Participants will be set up with a portable PSG device by sleep technicians in the sleep laboratory, but participants will be able to return home to undergo either THIM-administered Intensive Sleep Retraining or the control treatment.
Intervention code [1] 314618 0
Treatment: Devices
Intervention code [2] 314619 0
Behaviour
Comparator / control treatment
The control condition is the Sleep Hygiene Control group. Participants in this condition will be provided with the same sleep hygiene instructions that are provided to the THIM-administered Intensive Sleep Retraining intervention group. They will complete all measurements that the intervention condition completes, including overnight PSG recording on the first treatment night, sleep diaries, and actigraphy device measurement.
Control group
Active

Outcomes
Primary outcome [1] 320253 0
Mean Insomnia Severity Index score
Timepoint [1] 320253 0
Four weeks post-treatment and two-month follow up (primary endpoint)
Secondary outcome [1] 370988 0
Mean self-reported sleep parameters on the Sleep/Wake Diary (sleep onset latency, total sleep time, and sleep efficiency).
Timepoint [1] 370988 0
Four weeks post-treatment and two-month follow up
Secondary outcome [2] 370989 0
Mean sleep parameters from an actigraphy device (sleep onset latency, total sleep time, and sleep efficiency).
Timepoint [2] 370989 0
Four weeks post-treatment and two-month follow up
Secondary outcome [3] 370990 0
Mean score on the Pittsburgh Sleep Quality Index
Timepoint [3] 370990 0
Four weeks post-treatment and two-month follow up
Secondary outcome [4] 370991 0
Mean score on the Epworth Sleepiness Scale
Timepoint [4] 370991 0
Four weeks post-treatment and two-month follow up
Secondary outcome [5] 370992 0
Mean score on the Dysfunctional Beliefs About Sleep scale
Timepoint [5] 370992 0
Four weeks post-treatment and two-month follow up
Secondary outcome [6] 370993 0
Mean score on the Pre-Sleep Arousal Scale
Timepoint [6] 370993 0
Four weeks post-treatment and two-month follow up
Secondary outcome [7] 370994 0
Mean score on the Daytime Feelings and Functioning Scale
Timepoint [7] 370994 0
Four weeks post-treatment and two-month follow up

Eligibility
Key inclusion criteria
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 symptoms:
o Insomnia Severity Index score > 15
o Pittsburgh Sleep Quality Index score > 5
o Daytime Feelings and Functioning Scale score > 12
o Flinders Fatigue Scale > 8
o Dysfunctional Beliefs About Sleep Scale score > 3
o Pre-Sleep Arousal Scale score > 23
3. Self-report that these difficulties have persisted for >3 months.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• English language difficulties that might preclude fully informed consent.
• Taking medication which interferes with sleep
• Receiving other forms of sleep treatment
• Self-report sleep disorders other than Insomnia (e.g., Sleep Apnoea, Restless Legs Syndrome)
• Serious physical or mental health conditions
• Pregnancy/lactation
• Current smoker
• Excessive caffeine consumption (greater than or equal to 300mg per day)
• Excessive alcohol consumption (greater than or equal to 10 standard drinks per week)
• Recent trans-meridian travel (over at least 2 time zones) or shift work (within last 2 months)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomisation (4 participants per block).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We estimate that 17 participants per group will have 80% power (.05 alpha level) to detect a clinically significant six-point reduction (SD = 6.00) in Insomnia Severity Index score between the intervention and control condition.
Primary analyses will be conducted on an intention to treat basis, and the trial conducted and reported according to CONSORT guidelines. Patterns of missing data will be defined according to pre-determined guidelines (McKnight et al., 2007). Variable distributions will be examined to investigate homoscedasticity, outliers and normality, and corrected according to pre-determined statistical analysis plan. Linear mixed models will be used to examine the effect of group and time on the outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 26633 0
5042 - Flinders University

Funding & Sponsors
Funding source category [1] 302910 0
University
Name [1] 302910 0
Adelaide Institute for Sleep Health: A Flinders University Centre for Research Excellence
Address [1] 302910 0
AISH:FCRE, Level 2A
Box 6, Mark Oliphant Building, Flinders University
5 Laffer Drive, Bedford Park, South Australia, 5042
Country [1] 302910 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders University
Sturt Rd,
Bedford Park South Australia, 5042
Country
Australia
Secondary sponsor category [1] 302870 0
None
Name [1] 302870 0
Address [1] 302870 0
Country [1] 302870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303482 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 303482 0
SALHN Office for Research
Corporate Services
Southern Adelaide Local Health Network
Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 303482 0
Australia
Date submitted for ethics approval [1] 303482 0
30/11/2018
Approval date [1] 303482 0
20/05/2019
Ethics approval number [1] 303482 0
HREC/18/SAC/415

Summary
Brief summary
This project will be the first to test the effectiveness of the sleep wearable device called THIM for administering Intensive Sleep Retraining in the home environment. We will also examine the ability of THIM to provide effective and affordable treatment for insomnia, improve individual sleep health and general well-being. We predict that THIM-administered Intensive Sleep Retraining intervention condition will demonstrate:
• increased total sleep time and sleep efficiency;
• reduced sleep onset latency and time awake after sleep onset;
• improvements in daytime functioning measures
Compared to the Sleep Hygiene Control condition at post-treatment and two-month follow up time points.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93806 0
Miss Hannah Scott
Address 93806 0
AISH:FCRE, Level 2A
Box 6, Mark Oliphant Building, Flinders University
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 93806 0
Australia
Phone 93806 0
+61 8 82012767
Fax 93806 0
Email 93806 0
hannah.scott@flinders.edu.au
Contact person for public queries
Name 93807 0
Miss Hannah Scott
Address 93807 0
AISH:FCRE, Level 2A
Box 6, Mark Oliphant Building, Flinders University
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 93807 0
Australia
Phone 93807 0
+61 8 82012767
Fax 93807 0
Email 93807 0
hannah.scott@flinders.edu.au
Contact person for scientific queries
Name 93808 0
Miss Hannah Scott
Address 93808 0
AISH:FCRE, Level 2A
Box 6, Mark Oliphant Building, Flinders University
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 93808 0
Australia
Phone 93808 0
+61 8 82012767
Fax 93808 0
Email 93808 0
hannah.scott@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethics approval to share individual participant data.
What supporting documents are/will be available?
No other documents available
Summary results
No Results