Exploring Treatment Options for Obstructive Sleep Apnoea in People with Psychosis

This study will conduct a series of single case example designs with participants acting as their own baseline for comparison of treatment effects, using a bi-phasic A-B-A design for the Mandibular Advancement Splints, Night Shift and CPAP conditions (Arms 1, 3 and 4 respectively). It is expected that participants in each treatment phase (B) should show a difference on outcome measures such as lower OSA severity, improved clinical symptoms, cognitive functioning or quality of life compared to non-treatment phases (A). For the Didgeridoo (Arm 2) condition, a multiple baseline A-B design will be used, as the physiological effects of didgeridoo playing on throat muscles cannot be withdrawn fully after exercise cessation, unlike the other three conditions (where physiological effects are directly and temporarily linked to the usage of the device). A multiple baseline design means that participants will have differing amounts of time for collecting baseline data, before the treatment begins (e.g. three baseline data collection for Participant A, four baseline collections for Participant B etc.), whereas, a classic A-B-A design collects the same amount of baseline data from each participant. The study will comprise of one of the four treatment conditions, as well as four face-to-face appointments (baseline, pre- and post-treatment assessment and follow-up at the sixteenth-week time point), and seven short ‘check-up’ points (three times before treatment to establish a solid baseline, and every two weeks during treatment). The ‘check-up’ points will be conducted either via phone call or a text (according to the person’s preference), and will work to determine that participants are well, to help troubleshoot and answer any questions they might have, to check that participants are adhering to their treatment options, and to monitor changes in key symptom dimension across baseline and treatment phases (in addition to monitoring change more comprehensively during face-to-face appointments). At the check-up points, change in key symptom dimension will be assessed with questions about Health Status (7 items), and questions about treatment acceptability and side effects with Treatment Status (6 items). The check-up will be conducted with phone call or with text with link to an online survey (through secure REDCap server and comprising no personal identifying information). After an initial telephone call verifying the screening and eligibility criteria, the participant and PI will mutually agree on an available time for Session One (baseline) at a mental health service location that suits them. SESSION 1 (BASELINE) at the first face-to-face appointment (approx. 1.5 hrs), the session will include history taking (sleep problems and psychiatric issues) and questions about demographic info using a Clinical Sleep Interview. A brief psychoeducation session ~30 minutes about OSA will also be delivered. Brief psychoeducation is necessary so as to ensure that all participants have the same basic level knowledge about OSA. The contents will be derived from the Australasian Sleep Association and Sleep Health Australia, and resources and flyers will be especially adapted for consumers, with consumer input and co-production. Psychoeducation about OSA will comprise of: 1. OSA: What is it? Aim: to provide explanations about what is widely known about the sleep disorder within a normal continuum context. 2. What are the symptoms of OSA? Aim: to explain the common symptoms of OSA to help participants identify symptoms within themselves and others around them with similar mental health conditions. 3. How is OSA diagnosed? Aim: to explain the process of diagnosis for the sleep disorder using Polysomnography. 4. How is OSA treated? Aim: To explain the many things one can do to treat or reduce severity of OSA e.g. weight loss, drinking less alcohol, minimising use of sleeping tablets etc. Participants will then be booked in for their next face-to-face visit (pre-treatment outcomes assessment) and will be told they will be contacted three times (by phone and texts) over the next week to collect baseline measures of ‘health status’. CHECK-UP POINTS (pre-treatment): During the next week, The Principal Investigator will contact participants every 2 or 3 days (depending on participant or PI availability) by phone or texts to ask seven short questions (‘Health Status’ questions) using a 5-point Likert scale about the participant’s quality of sleep the night before, their impact of sleep on daily functioning and about night and daytime symptoms of OSA. These results will form a solid baseline measurement of OSA symptoms and severity pre-treatment. The same questions (Health Status) will be asked every two weeks during treatment phase, again at post-treatment assessment (week 9) and at the one month follow up (week 12) (with additional questions asking about treatment adherence and any issues with the devices). CHECK-UP POINTS (during-treatment): In addition to a Health Status questionnaire (as above), every 2 weeks during treatment, questions will be asked about ‘Treatment status’ at check-up points. Six 5-point Likert scale questions and one open-ended question will ask about the participant’s acceptability, usage, tolerance of their treatment as well as any issues encountered. SESSION 2 (PRE-TREATMENT). At the second face-to-face session, participants will complete their pre-treatment outcome measures assessment. The same measures will also be collected face-to-face at post-treatment assessment and follow-up. Questionnaires and tasks are outlined in step 4. In addition, all participants will be asked to undergo three optional overnight sleep studies with a portable home based device (ApneaLinkTM). ApneaLink is a simple, light weight device, which is worn as a chest belt while the person is asleep in the person’s own home/bed. The ApneaLink device measures nasal airflow (with nasal cannula), oxygen saturation, snoring, and pulse (finger oximeter), and chest breathing effort (with chest belt), from which it derives an apnoea-hypopnoea index (AHI). This is comparable to the AHI that is derived from participant’s initial diagnosis mechanism: Polysomnography. The device will be given to them during the first session, with explanations on how to fit it before bed time. ApneaLinkTM data will only be recorded at pre- and post-treatment outcome assessment (weeks 3, and 9 respectively). The ApneaLink devices will need to be picked up from participant’s the day after they have been used so that the Principal Investigator can download the sleep study data. Participants undertaking CPAP and Night Shift also have their own objective measures built into each device. Measures included for CPAP are: hours device is used throughout the night, number of nights where hours used is >4hrs, pressure and leak of the mask, and an Apnoea-Hypopnoea Index (AHI). For Night Shift positional therapy, objective measures are broken into three categories: sleep quality, positional feedback and snoring. The measures are further broken down into: number of supine (lying on back) attempts, sleep movement and intensity, sleep position (supine, upright, left, right or prone) and snoring intensity (decibels) and frequency. TREATMENT DETAILS: All participants will be given their respective treatment device in week 1 although each condition will require different time commitments (see below), and measurements: Arm 1: Mandibular advancement splints: Require one consultation prior to study by a dentist including an X-Ray, and mold fitting of the splint (occurring around 2-3 days before pre-treatment assessment). A second consult for appliance adjustment will be needed by a Dentist two weeks after receiving the device. Arm 2: Oropharyngeal exercise (Didgeridoo): digeridoo lessons will be required, whereby participants will have to attend four lessons and practice at least five times a week in between lessons to build up their upper airway muscles. Night shift Positional therapy device (Arm 3) and CPAP (Arm 4): Participants have the device available to them for the full 8 weeks of the study which they will be encouraged to use as much as they can (a minimum of 4 hours a night (e.g. half of the time based on an 8hr sleep cycle) in a 8 week period to determine that participants have used the devices and treatment was successfully implemented). CPAP has device check-up and adjustment points at week 2, 3 and 4 of the trial, whereas Night Shift has only one device review offered in week 2 of treatment. SESSION 3 (POST-TREATMENT). At post-treatment assessment (week 9), participants will undergo questionnaires again as per pre-treatment, as well as an ApneaLink study. At this point all participant’s treatment trial has ended. The nature of the SCED’s is that they can be tailored to each participant and thus, the researcher can wait until the participant has finished their prescribed treatment trial to complete the post-treatment assessments. SESSION 4 (follow-up). For the final follow up (week 13) after participants have gone 4 weeks without using the treatment device, participants will be invited to complete the questionnaires and ApneaLink overnight sleep study again.