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Project COMISA (Comorbid Insomnia and Obstructive Sleep Apnea): Investigating the effect of cognitive behavioral therapy for insomnia (CBT-I) in individuals experiencing comorbid insomnia and obstructive sleep apnea.

Project COMISA (Comorbid Insomnia and obstructive Sleep Apnea): A study investigating the effect of cognitive behavioral therapy for insomnia (CBT-I) on obstructive sleep apnea severity and cognitive functioning in patients experiencing COMISA.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000226707
Enrollment
25
Registered
2022-02-08
Start date
2022-04-12
Completion date
2024-05-15
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Insomnia and obstructive sleep apnoea (OSA) are the two most common sleep disorders in Australia. In fact, in up to 40% of people with either insomnia or OSA, the two disorders co-occur, known as COMISA (Comorbid Insomnia and obstructive Sleep Apnea). However, it is not fully understood why insomnia and OSA co-occur so often nor how sleep disturbance due to the combination of insomnia and OSA impacts an individual's cognitive functioning. The aim of this study is to better understand the connection between insomnia and OSA by examining how the gold-standard intervention for insomnia, cognitive behavioral therapy for insomnia (CBT-I) impacts 1) OSA severity as well as 2) the underlying factors which are known to cause OSA. This study will also investigate the impact of CBT-I on cognitive functioning suspected to be impacted due to sleep disruption and sleep disorders. It is hypothesized that 1) CBT-I will increase the arousal threshold to respiratory events and 2) this in turn will be associated with a reduction in OSA severity in patients with COMISA. Additionally, it is predicted that CBT-I will also be associated with an improvement in cognitive functioning. By undertaking this research, we may better understand how insomnia and OSA interact and how to treat these conditions more effectively.

Interventions

All participants involved with the study will receive 7 weekly treatment sessions of Cognitive Behavioural Therapy for Insomnia (CBT-I). This will be delivered via telehealth (i.e., via Zoom) with a trained clinician. All treatment sessions will take the format of individual, one-on-one sessions. Each session will run for approximately 1 hour. CBT-I is the gold-standard, multicomponent treatment for insomnia. Clinicians work with clients to help them make changes to their sleep-wake patterns,

All participants involved with the study will receive 7 weekly treatment sessions of Cognitive Behavioural Therapy for Insomnia (CBT-I). This will be delivered via telehealth (i.e., via Zoom) with a trained clinician. All treatment sessions will take the format of individual, one-on-one sessions. Each session will run for approximately 1 hour. CBT-I is the gold-standard, multicomponent treatment for insomnia. Clinicians work with clients to help them make changes to their sleep-wake patterns, to improve sleep and sleep efficiency. This includes setting regular sleep and wake times, getting out of bed when one is unable to sleep, sleep restriction and stimulus control. Cognitive restructuring of common misconceptions about sleep and unhelpful thought patterns, which may be perpetuating sleep problems is incorporated into the intervention. Finally, CBT-I includes education about improving the sleep environment and relaxation techniques. Throughout the intervention, participants are encouraged to practice 1-3 strategies learnt in session in between therapy sessions. Ideally, these strategies are used daily. During the course of treatment, participants will be provided with a manual which provides detailed information about the content covered in each session for participants to reference. This manual has been developed specifically for research involving the delivery of CBT-I by Prof. Drummond and colleagues who are leading experts in the field. Currently, it is not publicly available. During the intervention, participants will be provided with, and asked to wear an actiwatch (i.e., ambulatory sleep monitoring device) and complete a daily sleep diary to monitor their sleep throughout the course of the study. Clinicians Sleep clinicians will be registered provisional psychologists, trained by Chief Investigator Prof. Drummond who has clinical expertise in treating behavioural sleep disorders including Insomnia Disorder. Clinicians will be trained using methods based on those recommended by leading experts in the field Fidelity All clinicians will be regularly evaluated to ensure they are delivering the intervention properly. All treatment sessions will be recorded over Zoom. Every session from the first two cases of each treatment and 10% of all subsequent sessions will be evaluated by a registered psychologist trained in CBT-I for treatment fidelity (based on standardised check lists of session content). All recordings will be securely stored and kept confidential. Adherence Adherence to the components/activities of CBT-I will be monitored throughout the study via the sleep diary and an adherence questionnaire administered by the clinician.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Key inclusion criteria for all participants include: 1. English literacy 2. 18 years old or older 3. Diagnosis of DSM-5 Insomnia Disorder 4. Untreated Obstructive Sleep Apnea (defined as an apnea hypopnea index > 15 events per hour)

Exclusion criteria

1. Other unmanaged sleep disorder 2. REM Isolated obstructive sleep apnea 3. Shift work or trans meridian travel 4. Active episode of major depressive disorder 5. Active substance use disorder 6. Personal history of psychosis, bi-polar, or PTSD 7. Unmanaged major health condition 8. Neurological or respiratory conditions 9. Pregnancy or newborn under 1 year old

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026