Not Yet RecruitingNot Applicable

12-week Tele-exercise Program in Patients With OSA

60 participantsStarted 2024-09

Plain-language 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.

Who can participate

Age range

18 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * 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 * without daily physical working strain * without active self-reported symptoms (fatigue and dyspnea) * without pregnancy for women * patients with preexistent musculoskeletal disability will be excluded since their condition might impair maximum exercise capacity * all participants should speak and read Greek

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary aim of this study is to investigate the extent to which tele-exercise improves cognitive functions in patients with OSA

Timeframe: Baseline and after 12-week

Trial details

NCT IDNCT06467682

SponsorUniversity of Cyprus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials