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Published VersionCC BY V4.0, Open Access
Journal article
REducing Sleep Apnoea for the PrEvention of Dementia (REShAPED): Protocol for a multi-site feasibility randomised controlled trial
Contemporary Clinical Trials, Vol.137, pp.1-6
2024
PMID: 38145713
Appears in Thompson Institute Research Collection
Abstract
There is accumulating evidence that has linked OSA with increased risk of cognitive decline and dementia. Here we present the protocol for an Australian, multi-site randomised controlled, parallel open-label trial which will evaluate the feasibility for a full-scale trial investigating the effects of treating OSA on cognitive decline in older adults at risk of dementia within memory clinic settings. We will randomise 180 older adults to either the treatment intervention group or control group for 2 years. Inclusion criteria include: 50-85 years; mild-severe OSA (defined average ODI ≥ 10 with 3% oxygen desaturation determined by wrist oximetry over two nights); and subjective cognitive complaints or mild cognitive impairment. The treatment intervention arm aims to achieve an optimal treatment response based on reducing hypoxic burden with either CPAP, mandibular advancement splint, positional therapy, or oxygen therapy. Furthermore, participants will receive up to 8 sessions which involve motivational interviewing, collaborative goal setting, and behavioural sleep management. The control arm will not receive OSA treatment as part of this trial, however there will be no OSA treatment restrictions, and any treatment will be documented. Primary outcomes are 1) acceptability based upon willingness of participants to be randomised; 2) alleviating hypoxic burden by reducing OSA severity; 3) tolerability of the trial burden based upon collection of outcomes over the 2-year follow-up. Secondary outcomes include safety and cognitive function. Outcomes will be collected at 0, 6 and 24-months. This feasibility study aims to will provide the basis for a larger longer-term trial of dementia prevention.
Details
- Title
- REducing Sleep Apnoea for the PrEvention of Dementia (REShAPED): Protocol for a multi-site feasibility randomised controlled trial
- Authors
- Camilla M Hoyos (Corresponding Author) - Macquarie UniversityCraig L Phillips (Author) - Woolcock Institute of Medical ResearchNathaniel S Marshall (Author) - Woolcock Institute of Medical ResearchKristine Yaffe (Author) - University of California, San FranciscoRalph Martins (Author) - Macquarie UniversityJim Lagopoulos (Author) - University of the Sunshine Coast, Queensland, Thompson InstituteMelinda L Jackson (Author) - Monash UniversityLoren Mowszowski (Author) - The University of SydneyRonald R Grunstein (Author) - Royal Prince Alfred HospitalSharon L Naismith (Author) - The University of Sydney
- Publication details
- Contemporary Clinical Trials, Vol.137, pp.1-6
- Publisher
- Elsevier Inc.
- Date published
- 2024
- DOI
- 10.1016/j.cct.2023.107424
- ISSN
- 1559-2030; 1551-7144
- PMID
- 38145713
- Copyright note
- © 2023 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
- Data Availability
- No data was used for the research described in the article.
- Organisation Unit
- Thompson Institute
- Language
- English
- Record Identifier
- 99992998702621
- Output Type
- Journal article
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