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Trial registered on ANZCTR


Registration number
ACTRN12621001151820
Ethics application status
Approved
Date submitted
4/06/2021
Date registered
26/08/2021
Date last updated
26/08/2021
Date data sharing statement initially provided
26/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of antidepressants and continuous positive airway pressure (CPAP) in adults with depression and sleep apnoea - The Depression in Obstructive Sleep Apnoea Study.
Scientific title
A parallel, double blind, placebo controlled, randomised trial, investigating the effects of antidepressants and continuous positive airway pressure (CPAP) to reduce symptoms of Depression in adults with Obstructive Sleep Apnoea - The DOSA Study
Secondary ID [1] 304332 0
Nill known
Universal Trial Number (UTN)
None
Trial acronym
DOSA
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Depression, 322089 0
Sleep Apnoea 322090 0
Condition category
Condition code
Mental Health 319804 319804 0 0
Depression
Respiratory 319805 319805 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double-blind (for antidepressant use), parallel, placebo-controlled clinical trial using continuous positive airway pressure (CPAP), placebo and the antidepressant escitalopram for 12 weeks.

Intervention Group
Arm 1. CPAP + Escitalopram capsule (10mg orally per day in the morning) - Participants will be required to place the mask linked to the CPAP machine over their nose and mouth and keep this on for a minimum of 4 hours during the night when going to sleep. This process will need to continue over 12 weeks each night until the participant has been discharged from the study. Data will be collected from the CPAP machine when active that is electronically transferred to the sleep clinic. This data allows the study team to measure adherence and analyse data collected for each participant.

Arm 2. Escitalopram capsule (10mg orally per day in the morning)

All participants will be required to return their study medication (placebo and escitalopram at their follow up appointments with the study team at week 4 and week 12 in order to measure adherence. Participants will then be provided with a new set of study medication at week 4 and 12.
Intervention code [1] 320685 0
Treatment: Drugs
Comparator / control treatment
Double-blind (for antidepressant use), parallel, placebo-controlled clinical trial using CPAP, placebo and the antidepressant escitalopram for 12 weeks.

Arm 3. CPAP + Placebo capsule (1 capsule orally per day in the morning)
Arm 4. Placebo capsule. (1 capsule orally per day in the morning)

The placebo capsule will be composed of inert capsule filler consisting of maize starch and pregelatinised maize starch,
Control group
Placebo

Outcomes
Primary outcome [1] 327768 0
Change in depressive symptoms as measured by the Montgomery - Asberg Depression Rating Scale.
Timepoint [1] 327768 0
12 weeks post randomisation
Secondary outcome [1] 396520 0
Change in anxiety symptoms as measured by GAD-7
Timepoint [1] 396520 0
12 weeks post randomisation

Eligibility
Key inclusion criteria
1. Men and women aged 18 years or over.
2. Apnoea-hypopnoea index (AHI) equal to 15 and above on type I or II sleep study (AASM diagnostic criteria).
3. Clinical diagnosis of a major depressive episode according to DSM-5 criteria (single episode or as part of a recurrent depressive disorder).
4. MADRS equal to 20 and above (We will require participants to have at least moderately severe depressive symptoms in order to minimise possible ceiling effects associated with the intervention – i.e., limited room for improvement.)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. No GP or treating doctor
2. Any persons below the age of 18 years
3. Current use of antidepressant medication or Monoamine Oxidase Inhibitors (MAOI)
4. Established allergy to escitalopram or citalopram
5. Past or present diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
6. Alcohol or other substance-related disorder (except nicotine or caffeine)
7. Active suicidal intent
8. Evidence of cognitive impairment (Mini-Mental State Examination score of less than 24)
9. Presence of a health condition likely to limit 6-month survival or the ability to engage with the routines of the study
10. Epworth Sleepiness Scale score equal to 16 and above, or high risk driver occupation (e.g., truck, taxi)
11. Unable to communicate effectively in English
12. Enrolled in another intervention clinical trial involving an investigational product or device
13. Women who are pregnant
14. Any persons highly dependent on medical care
15. Unable or unwilling to offer informed consent to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
N/A
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical Analysis Primary Outcome: Difference in the proportion of participants achieving clinically significant improvement of the depressive episode by treatment group compared with the placebo control group (using proportion large sample statistics). This analysis will be intention-to-treat.

Secondary Outcomes: We will use multilevel mixed regression model to investigate the effect of treatment group over time on MADRS and GAD-7 scores. All other outcomes will be assessed by calculating differences in proportions according to treatment group compared with the placebo medication group. Should the groups be unbalanced, the relevant measures will be included in the regression and logit models.

Recruitment
Recruitment status
Not yet recruiting
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)
WA
Recruitment hospital [1] 19629 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 34262 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 308707 0
University
Name [1] 308707 0
The University of Western Australia (UWA)
Address [1] 308707 0
The WA Centre for Health & Ageing
The University of Western Australia (M577)
35 Stirling Highway
Crawley WA 6009
Country [1] 308707 0
Australia
Primary sponsor type
University
Name
The WA Centre for Health & Ageing - UWA
Address
The WA Centre for Health & Ageing
The University of Western Australia (M577)
35 Stirling Highway
Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 309681 0
None
Name [1] 309681 0
N/A
Address [1] 309681 0
N/A
Country [1] 309681 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308630 0
WA Health - North Metropolitan Health Service - Mental Health Research Ethics
Ethics committee address [1] 308630 0
North Metropolitan Area Mental Health Services HREC
Gascoyne House
Brockway Road
Mount Claremont
Western Australia 6010
Ethics committee country [1] 308630 0
Australia
Date submitted for ethics approval [1] 308630 0
28/04/2021
Approval date [1] 308630 0
05/08/2021
Ethics approval number [1] 308630 0
2006475

Summary
Brief summary
Obstructive sleep apnoea (OSA) affects 1 billion people worldwide. It is characterised by breathing pauses during sleep when the air passage in the throat narrows or blocks. The severity of OSA is based on the number of these breathing pauses per hour of sleep.
Recent studies suggest that OSA may be an important cause of depression. OSA and depression have common symptoms such as disrupted sleep, poor concentration, fatigue and low mood. Also, the risk factors for each condition overlap. It is difficult to know whether OSA causes depression (or vice-versa), or if these two conditions simply have overlapping features, but it is clear that 1 in every 4 adults with OSA have significant symptoms of depression.

The Depression in Sleep Apnoea study aims to determine if CPAP is more efficacious than placebo, and at least as efficacious as standard antidepressant medication (escitalopram), for the treatment of a major depressive episode in adults with OSA. CPAP is an approved intervention for the treatment of OSA, but its efficacy for the treatment of major depressive episodes has not been established. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) approved for the treatment of depression and anxiety, but it has not been tested for the treatment of a major depressive episode among adults with OSA nor as a treatment for OSA. Our objective is to identify if CPAP is more efficacious than placebo, and at least as efficacious as standard antidepressant medication, to treat a major depressive episode in adults with OSA.

We hypothesise that among adults with moderate-severe OSA and a major depressive episode will experience clinically significant improvement of depressive symptoms compared with participants randomly assigned to treatment that with placebo for 12 weeks.
Trial website
None
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 111370 0
Prof Osvaldo Almeida
Address 111370 0
The University of Western Australia
The WA Centre for Health & Ageing - School of Medicine
35 Stirling Highway (M577)
Crawley WA 6009
Country 111370 0
Australia
Phone 111370 0
+61 08 9224 4513
Fax 111370 0
Email 111370 0
Osvaldo.Almeida@uwa.edu.au
Contact person for public queries
Name 111371 0
Mrs Hema Patel
Address 111371 0
The University of Western Australia
The WA Centre for Health & Ageing - School of Medicine
35 Stirling Highway (M577)
Crawley WA 6009
Country 111371 0
Australia
Phone 111371 0
+61 08 9224 4525
Fax 111371 0
Email 111371 0
Hema.patel@uwa.edu.au
Contact person for scientific queries
Name 111372 0
Prof Osvaldo Almeida
Address 111372 0
The University of Western Australia
The WA Centre for Health & Ageing - School of Medicine
35 Stirling Highway (M577)
Crawley WA 6009
Country 111372 0
Australia
Phone 111372 0
+61 08 9224 4513
Fax 111372 0
Email 111372 0
Osvaldo.Almeida@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is in a pilot phase, data will only be shared should the participants in the study provide written consent to do so. The data collected will hold highly sensitive information about each participant's health - this information can not be released without written consent from the participant.
What supporting documents are/will be available?
No other documents available
Summary results
No Results