RecruitingACTRN12621001190897

Reducing Sleep Apnoea for the Prevention of Dementia

REducing Sleep Apnoea for the PrEvention of Dementia (REShAPED): a multi-site feasibility randomised controlled trial


Sponsor

The University of Sydney

Enrollment

90 participants

Start Date

Jun 27, 2022

Study Type

Interventional

Conditions

Summary

A major source of sleep disruption in older adults is obstructive sleep apnoea (OSA), a disorder characterised by frequent pauses in breathing due to partial or complete airway closure during sleep. These events result in sleep disturbance and oxygen deprivation, which previous studies have shown to be associated with an increased risk of dementia. Therefore, there is an imperative to establish definitively whether treatment of sleep apnoea can prevent dementia. This multi-site feasibility randomised-controlled trial aims to determine whether it is feasible to deploy a targeted intervention to treat sleep apnoea in participants with subjective memory complaints and determine the magnitude of effect on memory decline. Participants will be randomised to the intervention or control group for 2 years. Participants in the intervention group will receive treatment for their OSA following an algorithm and incorporating key principles of goal setting and behavioural sleep management. Participants in the control group will have their screening results sent to their referring medical practitioner, with recommendations for further investigation. Further, 90 participants will undergo a 25 min MRI at the study center during their standard visit at baseline and 24 months. For the MRI scan, participants will be selected based on participant choice and willingness to participate, as well as, if they pass the MRI safety questionnaire and consent. The primary outcome is the feasibility of the trial. The stop-go criteria to determine feasibility will depend on meeting the acceptability, hypoxic burden, and tolerability criteria. The secondary outcomes listed are primary being collected for the propose of showing feasibility of collection rather than serious intension of showing efficacy.


Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

Sleep apnoea is a condition where a person's breathing repeatedly stops and starts during sleep, often without them knowing it. This disrupts sleep quality and reduces oxygen levels, and research increasingly suggests it may be linked to a higher risk of developing dementia. This study is exploring whether treating sleep apnoea in older adults who are noticing memory changes could help protect brain health and slow cognitive decline over time. Participants are randomly assigned to an active treatment group — where their sleep apnoea is treated following a personalised protocol — or a control group where their GP is notified of the findings and left to manage as usual. Memory and brain health will be tracked over two years. A subset of participants will also have brain MRI scans at the start and end of the study. You may be eligible if you are aged 50–75, have noticed new memory difficulties in the past five years, and are found to have mild to severe sleep apnoea on a home oximetry test. People already using CPAP, those with a dementia diagnosis, or those with neurological, psychiatric, or major sleep disorders are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

CogSleep OSA Treatment: The intervention is to treat hypoxaemia due to obstructive sleep apnoea (OSA) in older adults for two years using a number of proven modalities including continuous positive ai

CogSleep OSA Treatment: The intervention is to treat hypoxaemia due to obstructive sleep apnoea (OSA) in older adults for two years using a number of proven modalities including continuous positive airway pressure (CPAP), mandibular advancement splints (MAS), positional therapy and oxygen therapy as determined by the medical officers. In most cases CPAP will be first line therapy. The frequency of the different modalities will be different for each individual as will the number and type of modalities used by each individual. Once provided to participants, all modalities are self-administered and individual will be ask to use the treatment nightly. Description of different modalities available: - CPAP is a machine that delivers air pressure through a face mask which covers participants nose or is placed over their nose and mouth while sleeping. - Mandibular advancement splints (MAS): These devices consist of a customized mouth guard used to treat OSA. MAS function by comfortably positioning the patient’s mandibular forward, clearing the obstructed airway and are only worn while the patient is sleeping. A dentist will need to take dental impressions from the patient to create the custom-made device. - Positional therapy: This device is a compact and is worn across participant’s chest in a soft, adjustable strap. This device delivers gentle vibrations that prompt the participant to shift to his/her side without disturbing his/her sleep. - Oxygen therapy: The oxygen is delivered through plastic tubing known as nasal cannula, typically at a rate of several liters per minute. A decision to step down to other modalities will be based on a treatment plan developed by CogSleep investigators in conjunction with the clinical opinion of the medical officer. Additionally, participants will receive up to 8 behavioural program sessions (30-60 minutes each) over a 6-month period. These sessions will be either face-to-face or telehealth consultations as decided between the trained sleep apnea therapist and the participant. The program will incorporate a collaborative approach using individualised and structured goal-setting in combination with motivational interviewing to further facilitate treatment adherence, engagement and maximal outcomes. The duration of the intervention will be 24 months, with OSA treatment occurring throughout, and the behavioural program for the first 6 months of the study. Treatment adherence using compliance reports from devices will be assessed through the 6 months program and then at 6 and 24 months. Treatment response will be assessed by hypoxic burden (sleep apnea severity) at 6 and 24 months. All participants in both arms will receive 8 psycho education emails for the first 6 months. The psychoeducation material was based on information developed in previous studies from our research lab, and updated to reflect more recent advances in evidence/best practice, as well as to better suit delivery via email. The emails will contain simple and practical tips about sleep hygiene (e.g. the impact of sleep on health, creating a sleep-conducive bedroom, sleep and memory, age-related sleep changes) and healthy brain ageing (e.g. importance of keeping the brain active, diet and exercise, brain health, depression and anxiety).


Locations(4)

Brain and Mind Centre - University of Sydney - Camperdown

NSW,QLD,VIC, Australia

Macquarie University Hospital - Macquarie Park

NSW,QLD,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,QLD,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,VIC, Australia

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ACTRN12621001190897


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