None listed
Conditions
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.
Interventions
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
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.
Sponsors
The WA Centre for Health & Ageing - UWA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.)
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.
Outcome results
None listed