12-week Tele-exercise Program in Patients With OSA
NCT Number: NCT06467682
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Obstructive Sleep Apnea|Cognitive Impairment
Interventions: OTHER: tele-exercise
Sponsor: University of Cyprus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-09
Completion Date: 2025-05

Summary:
Obstructive sleep apnea (OSA) contributes to a number of adverse health effects, particularly on brain health. Chronic sleep disturbances caused by OSA could adversely affect cognitive health. Exercise is recommended as a non-pharmacological intervention for patients who are intolerant to continuous positive airway pressure (CPAP) and has been shown to have beneficial effects on brain health and cognitive function. The aim of this protocol is to investigate the effects of a 12-week tele-exercise program on cognitive function and specific parameters of brain activity, including brain metabolism and oxygenation, in patients with OSA. The project aims to demonstrate the multi-dimensional relationship between exercise, cognition and brain oxygenation/metabolism. Our local ethics committee has approved the study. Our population sample (group A = OSA with cognitive impairment (CI) and tele-exercise; group B = OSA with CI and no tele-exercise; group C = OSA without CI and no tele-exercise) will undergo assessment both before and after a 12-week tele-exercise intervention program. This assessment will include a comprehensive battery of subjective and objective assessment tests. Data will be analysed according to group stratification. We hypothesize a beneficial effect of tele-exercise on sleep and cognitive parameters and we are confident that this study will raise awareness among healthcare professionals of the brain health benefits of exercise in patients with low compliance to CPAP treatment.

Primary Outcome Measures: The primary aim of this study is to investigate the extent to which tele-exercise improves cognitive functions in patients with OSA, Absolute number (scale score) in both the total score and the domains of the MoCA questionnaire (assessing cognitive impairment), individual patient, between baseline and after 12 weeks of intervention., Baseline and after 12-week
Secondary Outcome Measures: To investigate the extent to which tele-exercise has a positive impact on brain oxygenation in patients with OSA., Absolute number (μmol/L) in brain oxygenation (fNIRS method), individual of patient, between baseline and after 12 weeks of intervention., Baseline and after 12-week|To investigate the extent to which tele-exercise has a positive impact on brain metabolism in patients with OSA., Absolute number (μmol/L) in brain metabolism (fNIRS method), individual of patient, between baseline and after 12 weeks of intervention., Baseline and after 12-week|Investigate the extent to which tele-exercise has a positive impact on sleep architecture in patients with OSA., Percentage change for each sleep stage (REM and non-REM), individual of patient, between baseline and after 12 weeks of intervention., Baseline and after 12-week|To investigate to what extent tele-exercise has a positive effect on oxygen saturation during sleep in patients with OSA., Duration (min) of in-nadir oxygen saturation during sleep, individual of patient, between baseline and after 12 weeks of intervention., Baseline and after 12-week|To investigate the extent to which tele-exercise has a positive impact on Apnea Hypopnea Index in patients with OSA., Absolute number of Apnea Hypopnea Index (events/h), individual of patient, between baseline and after 12 weeks of intervention., Baseline and after 12-week