Efficacy of obstructive sleep apnea treatment in reducing fall risk in older adults: Study protocol for a clinical trial.

Background: Falls are a major cause of hospitalization fractures and functional decline in older adults. Obstructive sleep apnea (OSA), a highly prevalent sleep breathing disorder in older adults, has emerged as a potentially modifiable risk factor for falls. A small number of uncontrolled studies suggest OSA therapy by continuous positive airway pressure (CPAP) may reduce fall risk. We aim to describe the design of a randomized clinical trial that will evaluate if six months of CPAP intervention can significantly reduce fall risk markers in older adults with OSA.

Methods: 140 adults aged ≥60 years at risk of falls with diagnosed and untreated OSA will be randomized to receive CPAP and usual care for fall risk or only usual care for fall risk. The primary outcome will be the difference in fall risk scores, derived from the physiological profile assessment, between the two arms six months post-randomization. Secondary outcomes will include differences in gait, quality of life, sleep quality (self-reported and objective home-based monitoring), psychological well-being, cognitive function, physical performance, muscle strength, and body composition at six months post-randomization.

Results: Data will be analyzed on an intention-to-treat basis. Ethical approval was obtained from Southern Adelaide Clinical Human Research Ethics Committee in July 2023 (reference: 2023/HRE00081). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conferences.

Trial Registration Number: Australian New Zealand Clinical Trials Registry (ACTRN) 12623000965606.

Conclusion: The findings from this study will provide insight into the causal associations between OSA and fall risk and contribute to high quality evidence required to inform larger clinical trials and future guidelines for fall prevention.