Obstructive sleep apnoea and related symptoms study

In participants with Obstructive Sleep Apnoea (OSA) and depression, is Continuous Positive Airway Pressure (CPAP) effective in reducing the symptoms associated with depression?

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001136897

Enrollment

360

Registered

2012-10-24

Start date

2013-07-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Depression is one of the most frequent psychiatric disorders in obstructive sleep apnoea (OSA) and is associated with more severe OSA, reduced engagement with ontinuous positive airway pressure (CPAP) therapy, reduced quality of life and social functioning. CPAP therapy may be an effective option for treating depression in OSA. Hypotheses: 1. OSA participants with depression who receive CPAP will show a significant reduction in depression scores at 3 months follow-up compared with participants treated with Sham CPAP; and 2. The persistence of depression in OSA, despite CPAP treatment, will have a negative impact upon OSA outcomes including symptoms and compliance with therapy.

Interventions

Therapeutic Continuous Positive Airway Pressure plus humidification for 12 weeks. Treatment Arm 1 - Diagnosed depression* + obstructive sleep apnoea Treatment Arm 2 - No diagnosed depression* + obstructive sleep apnoea *Depression or no depression will be based on DSM-IV diagnostic criteria for mood disorders as assessed by the SCID Mood Episodes module A. CPAP involves the use of a machine during sleep that pumps air under gentle pressure, via a tube, to a mask that covers the nose (or mouth and nose). The air pressure acts to hold the upper airway open so that it does not collapse during sleep. Therapeutic CPAP therapy will involve the use of a CPAP device with variable pressure setting for the first week. After 1 week, a fixed-pressure CPAP will be prescribed, based on the pressure required to control 95% of periods of apnoea or hypopnoea. Participants will receive the prescribed pressure for 11 weeks. Participants will be encouraged to use the therapeutic CPAP device during periods of sleep each night. Hours of use, and days used will be recorded.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Apnoea/hypopnoea index (AHI) greater than 15

Exclusion criteria

Central (non-obstructive) sleep apnoea. Current or prior treatment for OSA, including: mandibular advancement splint; CPAP therapy; upper airway surgery; Provent Nasal Device (microvalve technology that provides expiratory positive airway pressure). Participants who meet the DSM-IV diagnostic criteria for psychotic symptoms as assessed by the SCID Psychotic Screen modules B/C; or participants who meet the DSM-IV diagnostic criteria for substance abuse or co-morbid alcohol use as diagnosed by the SCID Substance Use Disorders module E, within the 12 months prior to enrolment. Participants who are actively suicidal as assessed by the Columbia Suicide Severity Rating Scale.

Outcome results