Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000746437p
Ethics application status
Not yet submitted
Date submitted
12/06/2025
Date registered
15/07/2025
Date last updated
15/07/2025
Date data sharing statement initially provided
15/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a digital insomnia treatment pathway for co-morbid insomnia and sleep apnoea (COMISA) in Australian sleep clinic settings.
Scientific title
Feasibility and effectiveness of a digital cognitive behavioural therapy for insomnia (CBTi) program in sleep clinic patients with co-morbid insomnia and sleep apnoea: A randomised controlled implementation trial.
Secondary ID [1] 314382 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 337381 0
Sleep apnoea 337382 0
Condition category
Condition code
Neurological 333762 333762 0 0
Other neurological disorders
Respiratory 333763 333763 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised waitlist-controlled implementation trial will investigate the feasibility and effectiveness of providing Australian Sleep and Respiratory Physicians access to an online referral pathway, to refer their patients with co-morbid insomnia and sleep apnoea to an online Cognitive Behavioural Therapy for Insomnia (CBTi) program.

Sleep and Respiratory Physicians, and a selection of eligible patients they refer to the study will be recruited.

Two sub-groups of patients will be recruited;
1. At least 140 patients with co-morbid insomnia and sleep apnoea who have been recommended positive airway pressure therapy by a clinician, and
2. Up to 140 patients with co-morbid insomnia and sleep apnoea who have not been recommended positive airway pressure therapy by a clinician.

Patients referred to the trial by Sleep and Respiratory Physicians will undergo online screening and consent. Eligible patients will complete a baseline questionnaire battery before being randomised 1:1 (stratified by sub-group) to a 5-session online CBTi program, or waitlist education-control. Patients will complete outcome questionnaires at 8, 16, and 24 weeks. The waitlist control group will be provided access to the online CBTi program after the 24-week follow-up.

With consent from patients, referring Sleep and Respiratory Physicians will be provided a follow-up report of patient progress at 24 week follow-up. Sleep and Respiratory Physician follow-up reports will be generated by the study team and will include participant-level information on; insomnia symptoms before and after treatment, and date of next follow-up report.

Information about the online CBTi program appears below.

Rationale: Cognitive behavioural therapy for insomnia (CBTi) is the recommended 'first line' treatment for insomnia (Qaseem et al., 2016, Ann Intern Med). CBTi is also an effective treatment for insomnia in people with co-morbid insomnia and sleep apnoea (COMISA). However, very few Australian patients with insomnia or COMISA access CBTi (Miller et al., 2017, JCSM). This project aims to test the effectiveness of a self-guided digital CBTi intervention for people with COMISA in Australian sleep clinic settings.

Type: Non-drug, online, interactive.

Setting/location: Online, any location in Australia.

Duration: 5 x 20-30 minute online sessions, delivered over 5 consecutive weeks.

Protocol: Bedtime Window is an evidence-based self-guided personalised 5-session digital CBTi program. It is supported by randomsied controlled trial evidence in people with insomnia-alone (Sweetman et al., Int Med Journal, doi.org/10.1111/imj.16521), insomnia and a high-risk of sleep apnoea (Sweetman et al., Frontiers Sleep, doi.org/10.3389/frsle.2024.1355468), and people with comorbid insomnia and confirmed sleep apnoea (Sweetman et al., 2025. J Sleep Res. doi.org/10.1111/jsr.70114).

Content: Each session will be administered online (computer or mobile phone). Each session will contain videos, text, and images. Patients will be asked to enter text-based, numerical (e.g. minutes of sleep duration) and multiple-choice data throughout the program. Participants will receive tailored therapy recommendations during each weekly session (see Sweetman et al., 2024 Internal Medicine Journal, for tailored therapy recommendations). Immediately after each session is completed, participants will receive an automated follow-up email with session-specific 'follow-up' information and tailored therapy recommendations including recommended bedtime window (approximate reading time: 15 minutes). Participants will receive another automated email one week later with a link to start each subsequent session. Videos are presented by researchers, psychologists, and sleep technicians, each with extensive experience (>8 years) in the management of insomnia.

Tailoring / personalisation: Therapy recommendations will be tailored to participant's insomnia symptoms at baseline and weekly changes in symptoms throughout the program. Bedtime Restriction Therapy (initial restriction of time in bed to consolidate sleep, and subsequent gradual extension of time in bed) is a core component of CBTi. Bedtime restriction recommendations will be tailored to the specific sleep/wake information that participants provide.

Primary therapeutic components: Information about sleep, Sleep Hygiene education, Bedtime restriction therapy, Stimulus Control Therapy, Relaxation Therapy, Cognitive Therapy, Relapse Prevention.

Adherence assessment: Adherence will be defined as the number of participants commencing each of the 5 online sessions. This information is automatically collected through the online system.
Intervention code [1] 330993 0
Treatment: Other
Intervention code [2] 331365 0
Behaviour
Comparator / control treatment
Sleep education control.

Participants in the waitlist condition will receive weekly emails with written (pdf) information about insomnia and sleep health for the first 5 weeks of the trial. This includes information about;
- 'sleep hygiene' (healthy sleep behaviours)
- sleep myths and facts
- Information about caffeine and sleep
- depression and sleep
- chronic insomnia (symptoms, diagnosis, treatment options)

Each weekly information packet takes approximately 4 minutes to read.
Control group
Active

Outcomes
Primary outcome [1] 341344 0
Patient-level outcome: Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire.
Timepoint [1] 341344 0
Between-group change in ISI scores from baseline to 8-week, 16-week, and 24-week follow-up (primary timepoint).
Primary outcome [2] 341345 0
Patient-level outcome in sub-group of participants that are recommended Positive Airway Pressure (PAP) therapy: Between-group difference in self-reported average nightly use of PAP therapy.
Timepoint [2] 341345 0
Between-group difference in average nightly PAP use over a 2-week period at baseline, 8-week, 16-week, and 24-week follow-up (primary timepoint) in sub-group of participants that are recommended Positive Airway Pressure (PAP) therapy.
Secondary outcome [1] 447200 0
Sleep and Respiratory Physician-level outcome: Sleep and Respiratory Physician engagement (recruitment).
Timepoint [1] 447200 0
Number of Sleep and Respiratory Physicians recruited to the trial per month of the study.
Secondary outcome [2] 449807 0
Patient-level outcome in sub-group of participants recommended Positive Airway Pressure therapy: Between-group change in self-reported insomnia severity on the Insomnia Severity Index (ISI) questionnaire.
Timepoint [2] 449807 0
Between-group change in ISI scores from baseline to 8-week, 16-week and 24-week follow-up (primary time point) in sub-group of participants recommended Positive Airway Pressure therapy
Secondary outcome [3] 449808 0
Patient-level outcome: Between-group change in self-reported depression severity on the Patient Health Questionnaire (PHQ-9) questionnaire.
Timepoint [3] 449808 0
Between-group change in PHQ-9 scores from baseline to 8-week, 16-week, and 24-week follow-up (primary timepoint).
Secondary outcome [4] 449809 0
Patient-level outcome: Between-group change in self-reported fatigue severity on the Flinders Fatigue Scale (FFS) questionnaire.
Timepoint [4] 449809 0
Between-group change in FFS scores from baseline to 8-week, 16-week, and 24-week follow-up (primary timepoint).

Eligibility
Key inclusion criteria
Sleep and Respiratory Physician inclusion criteria:
1. Currently practicing as a Sleep and Respiratory Physician in Australia.

Patient inclusion criteria:
1. Aged at least 18
2. Referred by participating Sleep and Respiratory Physician.
3. Reliable access to computer, tablet or smartphone, with internet access.
4. Basic English language comprehension as required for digital CBTi program participation.
5. Sleep and Respiratory Physician diagnosis of obstructive sleep apnoea.
6. Insomnia Severity Index score =>8 (indicating at least Mild insomnia symptoms).
7. (For sub-group analysis) Previous recommendation of Positive Airway Pressure therapy by treating physician.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No excessive daytime sleepiness (Epworth Sleepiness Scale score greater than or equal to 16).
2. None of the following psychiatric conditions; Bi-polar disorder, schizophrenia.
3. No risk of suicide (PHQ-9; item 9 score of greater than or equal to 1).
4. No Epilepsy.
5. Not currently pregnant.
6. No commercial drivers or people who operate heavy machinery for work.
7. No people with a cognitive impairment.
8. No shift-workers.
9. Previous sleepiness-related motor vehicle accident.

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)
No allocation concealment will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (1:1) using a randomisation table created by computer software (i.e. computerised sequence generation)

The study will include two sub-groups of participants;
1. At least 140 patients with co-morbid insomnia and sleep apnoea that have previous been recommended Positive Airway Pressure (PAP) therapy, and
2. Up to 140 patients with co-morbid insomnia and sleep apnoeathat have not been recommended PAP therapy.

Randomisation will be stratified by study sub-group, to ensure equal allocation to intervention versus control groups in both sub-groups.
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
This implementation trial will recruit Sleep and Respiratory Physicians and the patients that they refer to this online insomnia treatment program study.

Sleep and Respiratory Physician-level analyses:
Primary endpoints will include rates of Sleep and Respiratory Physician engagement with the pathway (Sleep and Respiratory Physician completion of consent form, and rates of patient referrals over time).

Patient-level analyses:
Referred patients will be recruited to a parallel-arm randomised waitlist-controlled trial. Intention to treat, mixed models will be used to investigate between-group differences in changes in insomnia symptoms from baseline to 24-week follow-up, and (for the sub-group recommended PAP therapy) between-group differences in nightly average PAP use (minutes) at 24-week follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318900 0
Charities/Societies/Foundations
Name [1] 318900 0
American Academy of Sleep Medicine Foundation
Country [1] 318900 0
United States of America
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 321364 0
None
Name [1] 321364 0
Address [1] 321364 0
Country [1] 321364 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317515 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 317515 0
Ethics committee country [1] 317515 0
Australia
Date submitted for ethics approval [1] 317515 0
01/08/2025
Approval date [1] 317515 0
Ethics approval number [1] 317515 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141294 0
Dr Alexander Sweetman
Address 141294 0
School of Psychological Science, University of Western Australia, 35 Stirling Highway, 6009, Perth, Western Australia, Australia
Country 141294 0
Australia
Phone 141294 0
+61 8 6488 3141
Fax 141294 0
Email 141294 0
[email protected]
Contact person for public queries
Name 141295 0
Dr Alexander Sweetman
Address 141295 0
School of Psychological Science, University of Western Australia, 35 Stirling Highway, 6009, Perth, Western Australia, Australia
Country 141295 0
Australia
Phone 141295 0
+61 8 6488 3141
Fax 141295 0
Email 141295 0
[email protected]
Contact person for scientific queries
Name 141296 0
Dr Alexander Sweetman
Address 141296 0
School of Psychological Science, University of Western Australia, 35 Stirling Highway, 6009, Perth, Western Australia, Australia
Country 141296 0
Australia
Phone 141296 0
+61 8 6488 3141
Fax 141296 0
Email 141296 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No ethics approval for sharing of individual patient-level data is requested.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.