Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000226707
Ethics application status
Approved
Date submitted
27/01/2022
Date registered
8/02/2022
Date last updated
27/01/2023
Date data sharing statement initially provided
8/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 306210 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia Disorder 324918 0
Obstructive Sleep Apnoea (OSA) 324919 0
Condition category
Condition code
Respiratory 322352 322352 0 0
Sleep apnoea
Mental Health 322353 322353 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322614 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330121 0
A primary outcome is the change in obstructive sleep apnoea severity measured by the Apnoea Hypopnea Index (AHI)
Timepoint [1] 330121 0
The timepoints are 1. before treatment (pre treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Primary outcome [2] 330122 0
A primary outcome is the change in underlying obstructive sleep apnoea pathophysiology. This is operationalised as the four underlying traits known to contribute to obstructive sleep apnea (i.e., upper airway collapsibility, muscle compensation, loop gain, and the arousal threshold) which are assessed via 1) an epiglottic/esophageal pressure catheter and 2) an oronasal mask connected to a pneumotach during an overnight polysomnography.
Timepoint [2] 330122 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Primary outcome [3] 330123 0
Another primary outcome is the change in subjective cognitive functioning. This is operationalised by scores on the British Colombia Cognitive Complaints Inventory.
Timepoint [3] 330123 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. midway throughout treatment (prior to treatment session four) and 3. immediately following the last treatment session (post-treatment).
Secondary outcome [1] 404944 0
A secondary outcome is sleep-related declarative memory consolidation ability. This is operationalised by scores on a computerised paired associates learning (PAL) task.
Timepoint [1] 404944 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [2] 404945 0
A secondary outcome is cognitive effort discounting. This will be operationalised by scores on a task called the 'Cognitive Effort Task.'
Timepoint [2] 404945 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [3] 404946 0
A secondary outcome is subjective cognitive effort mobilisation during a working memory task. This is operationalised using a visual analogue scale measuring perceived effort application after each condition of a n-back task paradigm (i.e., 0, 1, 2, and 3-back).
Timepoint [3] 404946 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [4] 404947 0
A secondary outcome is objective cognitive effort mobilisation during a working memory task. This is operationalised using mean arterial blood pressure reactivity during each condition of a n-back task paradigm (i.e., 0, 1, 2, and 3-back).
Timepoint [4] 404947 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [5] 404948 0
Psychiatric symptoms - depression. This is operationalised by scores on the Patient Health Questionnaire-9.
Timepoint [5] 404948 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [6] 404949 0
Psychiatric symptoms - anxiety. This is operationalised by scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) - Anxiety 8a measure
Timepoint [6] 404949 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [7] 404950 0
Mental Wellbeing. This is operationalised by scores on the Warwick Edinburgh Mental Wellbeing Scale.
Timepoint [7] 404950 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [8] 404951 0
Subjective sleep related impairment. This is operationalised using scores from PROMIS - Sleep related impairment questionnaire.
Timepoint [8] 404951 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [9] 405138 0
Pre-sleep arousal. This is operationalised by scores on the Pre-sleep arousal scale (PSAS).
Timepoint [9] 405138 0
The timepoints are 1. before treatment (pre-treatment/baseline) 2. midway throughout treatment (prior to treatment session four) and 3. immediately following the last treatment session (post-treatment).
Secondary outcome [10] 405139 0
Fatigue. This is operationalised by scores on the Flinders Fatigue Scale.
Timepoint [10] 405139 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [11] 405958 0
A secondary outcome is subjective cognitive performance during a working memory task. This is operationalised using a visual analogue scale measuring perceived task performance after each condition of a n-back task paradigm (i.e., 0, 1, 2, and 3-back).
Timepoint [11] 405958 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [12] 405959 0
A secondary outcome is subjective cognitive motivation during a working memory task. This is operationalised using a visual analogue scale measuring subjective motivation after each condition of a n-back task paradigm (i.e., 0, 1, 2, and 3-back).
Timepoint [12] 405959 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [13] 405960 0
A secondary outcome is objective cognitive effort mobilisation during a working memory task. This is operationalised using mean systolic blood pressure reactivity during each condition of a n-back task paradigm (i.e., 0, 1, 2, and 3-back).
Timepoint [13] 405960 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [14] 405961 0
A secondary outcome is objective cognitive effort mobilisation during a working memory task. This is operationalised using mean arterial blood pressure reactivity during each condition of a n-back task paradigm (i.e., 0, 1, 2, and 3-back).
Timepoint [14] 405961 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [15] 405962 0
Social QoL. This is operationalised as the total score from the PROMIS satisfaction of social roles measure
Timepoint [15] 405962 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)
Secondary outcome [16] 405963 0
Insomnia Severity. This is operationalised using scores from the Insomnia severity index (ISI)
Timepoint [16] 405963 0
The timepoints are 1. before treatment (pre-treatment/baseline), 2. weekly during treatment, and 3. immediately following the last treatment session (post-treatment)
Secondary outcome [17] 405965 0
Subjective daytime sleepiness. This is operationalised using scores from the Epworth Sleepiness Scale (ESS)
Timepoint [17] 405965 0
The timepoints are 1. before treatment (pre-treatment/baseline) and 2. immediately following the last treatment session (post-treatment)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
12/04/2022
Date of last participant enrolment
Anticipated
21/11/2023
Actual
Date of last data collection
Anticipated
1/02/2024
Actual
Sample size
Target
40
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310635 0
Government body
Name [1] 310635 0
National Health and Medical Research Council
Country [1] 310635 0
Australia
Funding source category [2] 310718 0
Hospital
Name [2] 310718 0
Monash Health - Monash Lung and Sleep Institute
Country [2] 310718 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University,
Clayton Campus, Wellington Road,
Clayton, Victoria 3800
Country
Australia
Secondary sponsor category [1] 311596 0
None
Name [1] 311596 0
Address [1] 311596 0
Country [1] 311596 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310081 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 310081 0
Ethics committee country [1] 310081 0
Australia
Date submitted for ethics approval [1] 310081 0
05/11/2021
Approval date [1] 310081 0
08/12/2021
Ethics approval number [1] 310081 0

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

Contacts
Principal investigator
Name 116414 0
Prof Sean P. A. Drummond
Address 116414 0
Monash University School of Psychological Sciences,
18 Innovation Walk, Clayton Campus,
Wellington Road, Monash University,
Clayton, VIC, 3800
Australia
Country 116414 0
Australia
Phone 116414 0
+61 3 9905 3956
Fax 116414 0
Email 116414 0
[email protected]
Contact person for public queries
Name 116415 0
Elliot Brooker
Address 116415 0
Sleep and Circadian Medicine Laboratory
Be Active Sleep Eat Facility
264 Ferntree Gully Road,
Monash University, Notting Hill VIC 3168, Australia
Country 116415 0
Australia
Phone 116415 0
+61 4 12112814
Fax 116415 0
Email 116415 0
[email protected]
Contact person for scientific queries
Name 116416 0
Sean P. A. Drummond
Address 116416 0
Monash University School of Psychological Sciences,
18 Innovation Walk, Clayton Campus,
Wellington Road, Monash University,
Clayton VIC, 3800 Australia
Country 116416 0
Australia
Phone 116416 0
+61 3 9905 3956
Fax 116416 0
Email 116416 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographic information, psychological inventory data collected before and after treatment, and weekly data during treatment. All data will be de-identified.
When will data be available (start and end dates)?
Data underlying each manuscript will be made available following publication of that manuscript. No end date is yet determined.
Available to whom?
On a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
IPD Meta-Analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Prof. Drummond: [email protected]). The data will also be placed on a Monash University sponsored data repository.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14664Ethical approval    383339-(Uploaded-14-01-2022-16-43-35)-Study-related document.pdf



Results publications and other study-related documents

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