None listed
Conditions
Brief summary
Schizophrenia impacts 7 per 1000 people globally, and half have developed metabolic syndrome, representing significant cardiometabolic burden leading to excess early mortality. Moreover, schizophrenia commonly starts early in life (late adolescence and 20s), is chronic and requires long term pharmacotherapy which is often obesigenic. This means that individuals may begin to suffer from sleep apnoea much earlier than the general population and have a much longer life-time hypoxic burden. This 4-site 140 patient non-inferiority trial will inform health funders, clinicians, patients and their carers as to the 12-month clinical and cost benefits of funding simpler at home tests (i.e. 3 nights of at-home overnight oximetry instead of full in-laboratory polysomnography) for sleep apnoea in this special and severely undertreated population to speed access to treatment. Key clinical outcomes are Quality of Life (AQoL-8D - which also helps to inform the cost effectiveness), sleepiness, HbA1c, affect and cognition. Our highly skilled clinical and clinical trials research team will enable widespread and rapid translation of trial outcomes into clinical practice, creating a unique opportunity to gather evidence to generate significant health improvements for this high metabolic-risk population that is notably under-served. The main objective of this study is to evaluate whether 3-night home oximetry is clinically non-inferior (in terms of quality of life) and more cost effective, to the standard in-laboratory method.
Interventions
3 consecutive nights of home and patient administered wrist oximetry (Nonin WristOx2 Model 3150 ARTG Listing https://www.tga.gov.au/resources/artg/322415) for the diagnosis of sleep apnea. The strategy used to assess or monitor adherence or fidelity to the intervention will be a sleep technician will download the data from the machine to determine whether it was used and for how long after it is returned and this cannot be done remotely. Patients are provided with written instructions on how to
3 consecutive nights of home and patient administered wrist oximetry (Nonin WristOx2 Model 3150 ARTG Listing https://www.tga.gov.au/resources/artg/322415) for the diagnosis of sleep apnea. The strategy used to assess or monitor adherence or fidelity to the intervention will be a sleep technician will download the data from the machine to determine whether it was used and for how long after it is returned and this cannot be done remotely. Patients are provided with written instructions on how to fit and run the device at home and verbal clinical instruction from a sleep physician.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of schizophrenia or schizoaffective disorder recorded in medical records and under the care of a psychiatry service where one of our investigator psychiatrists practices. 2. Clinical suspicion of sleep apnoea or a StopBANG questionnaire score >=4 points 3. Able to provide informed written consent 4. Fluent English literacy
Exclusion criteria
1. Previous or current treatment for sleep apnea within the last year (including a surgical procedure aimed at addressing sleep apnea within the last year). Includes CPAP, Mandibular advancement splints, Hyperglossal nerve stimulators. Does not include internet or pharmacy sourced anti-snoring mouthguards. 2. Previous diagnosis or exclusion of sleep apnea within the last year based on any objective testing including polysomnography or overnight pulse oximetry and without major weight gain (i.e. >5%) in the opinion of the referring psychiatrist. 3. Any concomitant disease or condition that according to the investigator’s assessment makes the patients unsuitable for study participation
Outcome results
None listed