12-week Tele-exercise Program in Patients With OSA
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-69
SponsorUniversity of Cyprus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥18-to-≤70 years,
apnea hypopnea index (AHI) ≥15 events/h,
no contraindications (e.g. unstable angina during the previous month, myocardial infarction during the previous month, resting heart rate >120 bpm, systolic blood pressure >180 mmHg and diastolic blood pressure >100 mmHg) for 6-minute walk test (6MWT)
body mass index (BMI) <40 kg/m2
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
tele-exercise
Other interventionThe 12-week tele-exercise program will be performed and supported via the USTEP digital platform, with each patient taking part in 3 training sessions per week with a 60-min duration period per training session. There will be personalized training sessions: i) warm-up and warm-down, ii) aerobic exercise, and iii) strength exercises. All tele-exercise program participants, will use wearable-based tracking to assessment the cardio-oxygenation.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: 12-week intervention tele-exercise programOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and after 12-weekSecondary outcomes
1
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.
Time frame
Baseline and after 12-week2
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.
Time frame
Baseline and after 12-week3
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.
Time frame
Baseline and after 12-week4
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.
Time frame
Baseline and after 12-weekLocations
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Source ClinicalTrials.gov
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