Exploring the Clinical Efficacy of Remote Management Applications Through Comprehensive Physical Therapy for Patients With Moderate to Severe Sleep Apnea

Launched by CHINA NATIONAL CENTER FOR CARDIOVASCULAR DISEASES · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a comprehensive physical therapy program can help people with moderate to severe obstructive sleep apnea-hypopnea syndrome (OSAHS). OSAHS is a condition where breathing stops and starts during sleep, which can lead to various health issues. The study aims to explore whether using remote management applications, which can be accessed on smartphones, alongside physical therapy and exercise, can improve the health and sleep quality of patients who have recently been diagnosed and cannot tolerate traditional treatments like CPAP (Continuous Positive Airway Pressure).

To participate in this study, individuals should be between 18 and 60 years old and have been diagnosed with moderate to severe OSAHS. They should not have any serious heart or lung conditions, severe obesity, or be taking certain medications that affect sleep. Participants will receive a tailored physical therapy program and will be monitored through mobile health technology. This trial is not yet recruiting, so there will be more information available once it begins. If you or a loved one are interested, it is important to discuss this with a healthcare provider to see if you meet the criteria for participation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 to 60 years;
• • 2. Those who have been recently diagnosed with moderate-to- severe OSAHS (AHI ≥ 15 beats/h) and who refuse or cannot tolerate the counter-adverse effects and refuse CPAP therapy after conventional medical advice;
• • 3. Those who have not undergone any physical therapy;
• • 4. Have some communication and comprehension skills and can use a smart phone;
• • 5. Signed informed consent.
• Exclusion Criteria:
• • 1. BMI \> 35kg/m2;
• • 2. Patients with central and mixed sleep apnea;
• • 3. Those who use sleep aids (including benzodiazepines and non-benzodiazepine sedative-hypnotics, anxiolytics with sleep-aiding effects, antidepressants, antipsychotics) and/or nutritional supplements;
• • 4. Those suffering from acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other acute cardiovascular diseases;
• • 5. Those with severe respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), lung volume limitation (due to obesity, pregnancy, or spinal deformity), or cystic fibrosis, pneumothorax, or alveoli;
• • 6. Those with hypothyroidism;
• • 7. Those with severe ENT disorders such as severe upper airway obstruction (complete nasal congestion, tonsil grade III/IV), tongue-tie (Marchesani's protocol), motor symptoms limiting the tongue, antecedent or presence of temporomandibular joint disorders, and severe craniofacial injuries;
• • 8. Those with inflammation-related systemic diseases (e.g., arthritis, tuberculosis, vasculitis, lupus);
• • 9. Those who suffer from neuromuscular diseases (e.g., Duchenne muscular dystrophy) or diseases of the skeleton that prevent them from performing parallel movements due to exercise;
• • 10. Those who smoke and drink alcohol;
• • 11. Those who have had other sleep apnea treatments within 6 months (e.g., surgical procedures, MAD or CPAP treatments) that may affect the study results;
• • 12. Ongoing clinical trials of drugs or devices in which they are participating;
• • 13. Refusal to sign the informed consent form.