Exploring Treatment Options for Obstructive Sleep Apnoea in People with Psychosis

Not Applicable

• Conditions: obstructive sleep apnoea; schizophrenia; Respiratory - Sleep apnoea; Mental Health - Schizophrenia

• Registration Number: ACTRN12619000466145
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Inclusion criteria for participants include:
•A current diagnosis of psychotic disorder (schizophrenia-spectrum disorder, other psychosis, including anxiety or mood disorders with psychotic features, as diagnosed by their mental health worker)
•All participants must have a formal diagnosis of OSA confirmed by sleep study (PSG). We will ask them to sign a ‘consent to release’ document, seeking the results of the PSG detailing their sleep disorder diagnosis.
•Those in the Mandibular Advancement Splint and CPAP will need to have been prescribed those treatments prior to participating in the study (as evidenced in the sleep study results letter)
•Night Shift participants will need to have a diagnosis of Positional OSA as determined by their PSG data which will be obtained with participant’s consent from the provider of the diagnosis.

Exclusion Criteria

Exclusion criteria include:
•Inability to provide informed consent
•Inability to communicate adequately in English
•Currently experiencing crisis or clinical instability (as assessed by their case manager)
•Aggression, problematic drug/alcohol usage associated with behavioural or security issues

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this trial is to test the efficacy and tolerability of OSA treatment devices in people with psychosis. This will be analysed by looking at 1) the difference between pre- and post- intervention AHI measures, as derived from participant's portable Polysomnography device (ApneaLinkTM). 2) To assess tolerability, participants will complete a Treatment Status questionnaire which asks both closed-ended and open-ended questions about frequency of device usage, perceived impact of device usage on quality of sleep, and impact of side-effects on device usage.[For AHI measures using ApneaLinkTM portable polysomongraphy device, participants will compete this measure pre-treatment and post-treatment (Week 3 and 12 respectively). <br><br>For Treatment Status Questionnaire measures, these will be collected every two weeks during the treatment phase of the trial (Weeks 5, 7, 9 and 11) and will occur at post-treatment assessment and 1month follow up at weeks 12 and 15 respectively.]