None listed
Conditions
Brief summary
Comorbid insomnia and sleep apnoea (COMISA) is a prevalent and debilitating disorder in Australian sleep clinic settings. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTi). CBTi is effective in patients with comorbid sleep apnoea. However, very few patients with COMISA access CBTi. Digital CBTi programs are an effective and potentially scalable intervention to manage insomnia. There are currently no publicly-available self-guided digital CBTi programsin Australia that provide personalised weekly behavioural therapy recommendations, and no programs tailored for COMISA. This randomised controlled implementation trial will recruit two sub-groups of patients with COMISA; 1. At least 140 patients that have been recommended Positive Airway Pressure (PAP) therapy by a treating clinician, and 2. Up to 140 patients that have not been recommended PAP therapy. This trial aims to investigate the feasibility and effectiveness of a digital CBTi referral pathway for people with COMISA in Australian sleep clinic settings. Patients that are referred, eligible and consent to participate will be randomised 1:1 (stratified by sub-group) to a digital brief CBTi program, versus waitlist education control. The RE-AIM framework will be used to investigate the effectiveness and implementation of the intervention. Reach o Sleep and Respiratory Physicians in all States/Territories of Australia will participate. o At least 50 Sleep and Respiratory Physicians will be recruited. Effectiveness o The CBTi group will report a greater improvement in symptoms of insomnia, depression, and fatigue from baseline to 8-weeks, and baseline to 24-week follow-up (primary time point), compared to the education control group. o Among a sub-group of 140 patients recommended PAP therapy, the CBTi group will report greater nightly average use of PAP therapy at 24-week follow-up (primary time point) compared to the education control group. Adoption o There will be an increasing number of patients referred to the study per month of the study. o At least 400 patients with suspected COMISA will be referred. o At least 80% of patients allocated to the intervention group will commence the digital CBTi program. Implementation o Qualitative interviews with Physicians and patients will indicate that the pathway and CBTi program is acceptable and feasible. o At least 60% of patients allocated to the intervention group will complete the full 5-session program. Maintenance o There will be an increasing number of patients referred to the study by participating sleep physicians per month of the study. o Improvements in insomnia, depression, and fatigue following digital CBTi will be sustained by 24-weeks. o Qualitative interviews with Physicians and patients will indicate interest in sustained access to the pathway after conclusion of the study.
Interventions
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
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.
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed