Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000013662
Ethics application status
Approved
Date submitted
12/12/2013
Date registered
6/01/2014
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Do Treatment Interventions for Obstructive Sleep Apnoea Reduce Depressive Symptoms in Patients with Comorbid Depression?
Scientific title
Does Continuous Positive Airway Pressure (CPAP) Treatment for Obstructive Sleep Apnoea improve Depression?
Secondary ID [1] 283771 0
None
Universal Trial Number (UTN)
Trial acronym
COSAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 290745 0
Depression 290746 0
Condition category
Condition code
Respiratory 291104 291104 0 0
Sleep apnoea
Mental Health 291105 291105 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CPAP therapy. CPAP treatment involves wearing a mask that is attached to a pump that forces air into the airway to hold the airway open during sleep. The dosage will be individually determined during an in-laboratory CPAP implementation sleep study at the start of the trial. This treatment should be used every night, for 12 months for the CPAP group, or 8 months for the wait-list group. Usage data is recorded automatically by the device and can be downloaded by the researchers at each visit. The CPAP group will be provided with a 1-hour CPAP and sleep education session by a sleep scientist or psychologist (either one-on-one or in small groups), a CPAP information booklet, and follow up phone call from a sleep scientist after night 1 and night 7 at home to troubleshoot any problems (~5 minutes duration). The treatment as usual (TAU) group will receive CPAP without additional follow up procedures or education.
Intervention code [1] 288455 0
Treatment: Devices
Comparator / control treatment
Wait-list for 4 months, after which this group will receive the CPAP treatment.
Control group
Active

Outcomes
Primary outcome [1] 291092 0
Depression score - (Center for Epidemiology - Depression scale)
Timepoint [1] 291092 0
1, 2, 4 and 12 months
Primary outcome [2] 291093 0
Daytime Sleepiness (Epworth Sleepiness Scale (ESS)
Timepoint [2] 291093 0
1, 2, 4 and 12 months
Secondary outcome [1] 305992 0
Emotional Reactivity Scale and Difficulties in Emotional Regulation Scale
Timepoint [1] 305992 0
1, 2, 4, 12 months

Eligibility
Key inclusion criteria
Untreated OSA patients who have been recommended to start CPAP therapy; English fluency; not pregnant or possibility of being pregnant; CES-D score >16. Patients with a current clinical diagnosis of depression, and who are on antidepressants will also be included.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of or current psychiatric or medical condition (except depression) including epilepsy, recent stroke, myocardial infarction (in last 6 months); excessive daytime sleepiness (ESS>16); head injury with loss of consciousness >15 mins; learning disability; alcohol or drug dependence; shiftwork; and any neurological disorder or inability to complete the trial at the judgment of the clinician investigator.

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)
Participants will be stratified by depression and daytime sleepiness score, and randomized into one of three conditions: a new CPAP treatment group (CBT), the current CPAP treatment group (TAU) or a wait-list group. Group allocation is concealed between the TAU and CBT groups. Allocation is conducted via centralized randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After each subject has been assessed for depression and sleepiness, they will be assigned a random number using an on-line number generator program into the CPAP, TAU or wait-list group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Partial cross-over - CPAP group will not cross over to waitlist.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention-to-treat principle will be employed. Statistical analysis will be in the form of a repeated measures ANCOVA model with CES-D score, memory sensitivity and sleepiness as the primary outcome measures, with baseline depression score as a covariate. Treatment group (CPAP vs TAU vs. wait list) and time (1, 2, 4 and 12 months) will be included in the model as independent variables. Secondary analyses will be performed to evaluate effect modification across levels of the depression stratification factor (MDD vs. mild-no depression) to examine a potential interaction between treatment group and baseline depression category. Regression analyses will be conducted to determine whether quality of relationship, personality and/or depression scores at baseline differ between those participants who continue CPAP and those who stop treatment.

We plan to recruit 120 OSA patients. This sample size is calculated assuming an SD of 8 for change in CES-D score over 3 months as estimated using individual patient data (Baron, Smith et al. 2008). A change in CES-D score of 5 or more constitutes a clinically significant change (Jacobson and Truax 1991). Therefore, we need a total 33 patients in each group to detect an effect size of 5, assuming an SD of 8, Beta = 0.80 and alpha less than or equal to 0.05. We estimate 20% attrition; therefore we will recruit 40 participants in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2014
Actual
19/02/2015
Date of last participant enrolment
Anticipated
Actual
8/09/2017
Date of last data collection
Anticipated
27/09/2019
Actual
21/01/2019
Sample size
Target
120
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288434 0
University
Name [1] 288434 0
The University of Melbourne
Country [1] 288434 0
Australia
Funding source category [2] 294029 0
Hospital
Name [2] 294029 0
Austin Medical Research Foundation
Country [2] 294029 0
Australia
Primary sponsor type
University
Name
Royal Melbourne Institute of Technology
Address
PO Box 17
Bundoora 3083
Victoria
Country
Australia
Secondary sponsor category [1] 287137 0
None
Name [1] 287137 0
None
Address [1] 287137 0
None
Country [1] 287137 0
Other collaborator category [1] 277731 0
Hospital
Name [1] 277731 0
Austin Health
Address [1] 277731 0
Studley Rd Heidelberg, Vic, 3084
Country [1] 277731 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290309 0
Austin Health
Ethics committee address [1] 290309 0
Studley Rd Heidelberg, Vic, 3084
Ethics committee country [1] 290309 0
Australia
Date submitted for ethics approval [1] 290309 0
14/05/2013
Approval date [1] 290309 0
27/11/2013
Ethics approval number [1] 290309 0
05076

Summary
Brief summary
Obstructive Sleep Apnoea (OSA) is a common respiratory disease, caused by collapse of the airway during sleep, which produces oxygen desaturations and sleep disruption. OSA is associated with cognitive deficits, reduced quality of life, and depressed mood. The prevalence of both depressive symptoms and major depressive disorder (MDD) are significantly higher in OSA patients compared to the general community. Currently there is little clinical evidence to support whether treatment of OSA improves depressive symptoms in OSA patients with comorbid depressive symptoms or MDD. The aim of this study is to determine whether CPAP treatment improves depressive symptoms and cognitive functioning over the short and long term. This project is a prospective, randomised controlled trial of an enhanced CPAP treatment program for OSA patients with comorbid MDD and depressive symptoms, compared to a wait list control group, and treatment as usual. This study will provide much-needed clinical evidence of the efficacy of CPAP therapy for improving both depression and cognitive functioning in OSA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44978 0
Dr Melinda Jackson
Address 44978 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, Vic 3164
Country 44978 0
Australia
Phone 44978 0
+613 99050206
Fax 44978 0
Email 44978 0
[email protected]
Contact person for public queries
Name 44979 0
Dr Melinda Jackson
Address 44979 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, Vic 3164
Country 44979 0
Australia
Phone 44979 0
+61 399050206
Fax 44979 0
Email 44979 0
[email protected]
Contact person for scientific queries
Name 44980 0
Dr Melinda Jackson
Address 44980 0
Turner Institute for Brain and Mental Health
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, Vic 3164
Country 44980 0
Australia
Phone 44980 0
+61 399050206
Fax 44980 0
Email 44980 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Do not have ethics approval for this


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Jackson ML, Tolson T, Bartlett D, Varma P, Berlowi... [More Details]
Conference abstractNo Tolson J, Barnes M, Bartlett DJ, Trinder J, Rochfo... [More Details]
Other filesNo Jackson ML, Tolson J, Bartlett DJ, Barnes M. (2016... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes continuous positive airways pressure treatment improve clinical depression in obstructive sleep apnea? A randomized wait-list controlled study.2021https://dx.doi.org/10.1002/da.23131
EmbaseA randomized controlled trial of a multi-dimensional intervention to improve CPAP use and self-efficacy.2023https://dx.doi.org/10.1016/j.sleep.2023.06.024
EmbaseImproved depressive symptoms, and emotional regulation and reactivity, in individuals with obstructive sleep apnea after short- and long-term CPAP therapy use.2023https://dx.doi.org/10.1016/j.sleep.2023.08.024
N.B. These documents automatically identified may not have been verified by the study sponsor.