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Trial registered on ANZCTR


Trial ID
ACTRN12613001178730
Ethics application status
Approved
Date submitted
25/10/2013
Date registered
28/10/2013
Date last updated
21/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating Comorbid Insomnia with Obstructive sleep Apnoea (COMISA) Study: A new treatment strategy for patients with combined insomnia and sleep apnoea.
Scientific title
Treating Comorbid Insomnia with Obstructive Sleep Apnoea (COMISA): A randomised controlled trial evaluating the effectiveness of a new treatment strategy incorporating Cognitive Behaviour Therapy for Insomnia (CBTi) plus treatment as usual for patients with combined insomnia and sleep apnoea
Secondary ID [1] 283440 0
Nil known
Universal Trial Number (UTN)
U1111-1149-4230
Trial acronym
COMISA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 290351 0
Obstructive Sleep Apnoea 290352 0
Condition category
Condition code
Respiratory 290747 290747 0 0
Sleep apnoea
Mental Health 290748 290748 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is Cognitive Behaviour Therapy for Insomnia (CBTi) plus Treatment As Usual (TAU) for Obstructive Sleep Apnoea.
Four 1 hour CBTi sessions will occur at weekly intervals in a face-to-face group session of 2 or more participants (depending on recruitment numbers) before starting on Continuous Positive Airway Pressure (CPAP) therapy at home for 6 months.
CBTi Session 1: Sleep education - Bedtime Restriction therapy. CBTi Session 2: Misperceptions of sleep - Polysomnograph (PSG) Feedback. CBTi Session 3: Hyperarousal and Anxiety in Insomnia. CBTi Session 4: Review and Relapse Prevention.
Participants will be asked to keep four 1-week sleep diaries and a record of their thoughts and feelings on sleep.
Participants receiving CBTi will given a CBTi Participant Manual which explains the process of sleep and some of the factors which can cause and maintain insomnia and effective treatment and strategies for insomnia.
Intervention code [1] 288158 0
Behaviour
Comparator / control treatment
The control group will receive Treatment as Usual (CPAP therapy at home for 6 months) for Obstructive Sleep Apnoea only.
Control group
Active

Outcomes
Primary outcome [1] 290747 0
CPAP Adherence - the average hours/night of machine use at therapeutic pressure recorded over 6 months.
Timepoint [1] 290747 0
At 3 months and 6 months after start of CBTi.
Primary outcome [2] 290748 0
Insomnia - Sleep efficiency measured by home Polysomnography (PSG) at baseline, 6 weeks, 3 months and 6 months.
Timepoint [2] 290748 0
At baseline, 6 weeks and 6 months.
Secondary outcome [1] 305157 0
Measure of the impact of sleep disorders on daily functioning and quality of life as assessed by the Functional Outcomes of Sleep Questionnaire (FOSQ).
Timepoint [1] 305157 0
At baseline and at 6 weeks, 3 months and 6 months after start of CBTi.
Secondary outcome [2] 305158 0
Measurement of the perceptions and distress relating to insomnia and impact on the quality of life as measured by the Insomnia Severity Scale (ISI).
Timepoint [2] 305158 0
At baseline and at 4 weeks, 6 weeks, 3 months and 6 months after start of CBTi.
Secondary outcome [3] 305159 0
A self report measure designed to evaluate sleep related cognitions that play a role in perpetuating insomnia as measured by the Dysfunctions Beliefs and Attitudes about Sleep (DBAS-16).
Timepoint [3] 305159 0
At baseline and at 6 weeks, 3 months and 6 months after start of CBTi.
Secondary outcome [4] 305160 0
Measurement of daytime fatigue associated with insomnia utilising the Flinders Fatigue Scale (FFS).
Timepoint [4] 305160 0
At baseline and at 6 weeks, 3 months and 6 months after start of CBTi.
Secondary outcome [5] 305161 0
Daytime Feelings and Functioning Scale (DFFS) that assesses the frequency of specific daytime deficits commonly reported in insomnia
Timepoint [5] 305161 0
At baseline and at 6 weeks, 3 months and 6 months after start of CBTi.
Secondary outcome [6] 305162 0
Health status score, and a preference score that will allow computation of utilities for the estimation of quality adjusted life years (QALYs) within cost effectiveness analysis as measured by the Assessment of Quality of Life Index (AQoL).
Timepoint [6] 305162 0
At baseline and at 6 weeks, 3 months and 6 months after start of CBTi.
Secondary outcome [7] 305163 0
A standardised measure of health status at 5 levels of severity in each of the 5 dimensions as measured by the European Quality of Life (EQ-5D-5L) questionnaire.
Timepoint [7] 305163 0
At baseline and at 6 weeks, 3 months and 6 months after start of CBTi.
Secondary outcome [8] 305164 0
Productivity Cost Questionnaire (iMTA PCQ) measures and subsequently values indirect costs arising outside the scope of the healthcare system, also known as productivity costs.
Timepoint [8] 305164 0
At baseline and at 6 weeks, 3 months and 6 months after start of CBTi.

Eligibility
Key inclusion criteria
1. Age greater than or equal to18 years of age up to and including 75 years of age. 2. An apnoea/hypopnoea index (AHI) greater than 15 events per hour of sleep by polysomnography (PSG) with clinical diagnosis of OSA confirmed by treating consultant respiratory physician. 3. Recommended by treating sleep physician for CPAP treatment. 4. A diagnosis of Insomnia to ICSD-2 criteria, Insomnia Severity Index Score greater than 13.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe daytime sleepiness, or other reason, which in the opinion of the treating physician would cause undue risk to the patient’s safety during the CBTi treatment period while awaiting CPAP treatment.
2. Any other sleep disorder (eg REM behaviour disorder, severe restless legs syndrome) which in the opinion of the treating physician is the dominant sleep diagnosis and which requires immediate treatment. Patients with other medical or psychiatric conditions (e.g. depression & anxiety) will not be excluded, but diagnoses recorded from the patient’s file for reporting and analysis purposes.

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 will be provided by an independent central allocation service (Pharmacy Department, Repatriation General Hospital) to ensure concealment, documentation and integrity.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A minimisation program will stratify treatment allocation by site, severity of insomnia (ISI score > and < 22) and OSA (AHI > and < 30).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention to treat basis, and the trial conducted according to CONSORT guidelines. Missing data will be imputed using multiple imputations.
All calculations assume an overall Type 1 error rate of 0.05% and a Type 2 error rate of 20%. A total sample of 126 participants (63 per group) provides 80% power to detect an improvement of 1.25 hrs per night in CPAP adherence, based on standard deviations for CPAP use in TAU groups of approximately 2.5 hrs/night.
Enrollment of 140 participants allows the completion of an adequately powered per protocol analysis assuming a 10% attrition rate, and increases power in the primary ITT analysis to 85%.
A greater than 1.25 hrs/night in CPAP adherence is expected after CBTi because of increases in sleep efficiency (ie sleep time) and greater overall CPAP treatment acceptance and tolerance; the consensus amongst the participating sleep physicians is that a change of less than 1.25 hrs/night is unlikely to be clinically significant.
A 5% change in PSG-derived sleep efficiency is considered clinically significant and the minimum expected from other CBTi trials. The sample of 140 provides 80% power to detect this difference assuming a standard deviation in the order of 7.5. For ISI there is 80% power to detect difference of 3.4 ISI units groups (moderate clinical change in ISI is approx 8.5), assuming a standard deviation in the order of 5.
The sample size gives 80% power to detect a change of 8.6 FOSQ units ( typical moderate change is approx 12 units) assuming a standard deviation of change of 18.

Recruitment
Recruitment status
Completed
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)
QLD,SA
Recruitment hospital [1] 1608 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 1609 0
Repatriation Hospital - Daw Park
Recruitment hospital [3] 1610 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 7483 0
5041 - Daw Park
Recruitment postcode(s) [2] 7484 0
5042 - Bedford Park
Recruitment postcode(s) [3] 7485 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 288159 0
Government body
Name [1] 288159 0
National Health and Medical Research Council
Address [1] 288159 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 288159 0
Australia
Primary sponsor type
Individual
Name
Prof Doug McEvoy
Address
Adelaide Institute for Sleep Health
Repatriation General Hospital - Block C
Daws Road
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 286882 0
None
Name [1] 286882 0
Address [1] 286882 0
Country [1] 286882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290075 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 290075 0
Flinders Medical Centre
The Flats G5 – Rooms 3 and 4
Flinders Drive,
Bedford Park
SA 5042
Ethics committee country [1] 290075 0
Australia
Date submitted for ethics approval [1] 290075 0
27/11/2012
Approval date [1] 290075 0
14/05/2013
Ethics approval number [1] 290075 0
428.12
Ethics committee name [2] 290076 0
Queensland University of Technology Research Ethics Unit
Ethics committee address [2] 290076 0
Level 4
88 Musk Avenue
Kelvin Grove
Queensland 4059
Ethics committee country [2] 290076 0
Australia
Date submitted for ethics approval [2] 290076 0
Approval date [2] 290076 0
05/06/2013
Ethics approval number [2] 290076 0
1300000302

Summary
Brief summary
1. To conduct a randomized controlled trial of Cognitive Behaviour Therapy for insomnia (CBTi) in patients with co-morbid Obstructive sleep Apnoea (OSA) and insomnia to establish whether CBTi therapy improves Continuous Positive Airway Pressure (CPAP) adherence and sleep-related patient outcomes.
2. To explore whether insomnia and OSA are causally inter-related.
Trial website
http://www.adelaidesleephealth.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43794 0
Prof Doug McEvoy
Address 43794 0
Adelaide Institute for Sleep Health
Repatriation General Hospital - Block C
Daws Road
Daw Park
SA 5041
Country 43794 0
Australia
Phone 43794 0
+61 8 82751187
Fax 43794 0
+61 8 82776890
Email 43794 0
doug.mcevoy@health.sa.gov.au
Contact person for public queries
Name 43795 0
Ms Mandy O'Grady
Address 43795 0
Adelaide Institute for Sleep Health
Repatriation General Hospital - Block C
Daws Road
Daw Park
SA 5041
Country 43795 0
Australia
Phone 43795 0
+61 8 82751301
Fax 43795 0
+61 8 82776890
Email 43795 0
amanda.o'grady@sa.gov.au
Contact person for scientific queries
Name 43796 0
Prof Doug McEvoy
Address 43796 0
Adelaide Institute for Sleep Health
Repatriation General Hospital - Block C
Daws Road
Daw Park
SA 5041
Country 43796 0
Australia
Phone 43796 0
+61 8 82751187
Fax 43796 0
+61 8 82776890
Email 43796 0
doug.mcevoy@health.sa.gov.au