None listed
Conditions
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.
Interventions
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 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.
Sponsors
Royal Melbourne Institute of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed