Official Title
Effect of Mobile-health and Comprehensive Physical Therapy on Moderate-to-severe Obstructive Sleep Apnea Hypoventilation Syndrome
Brief Summary

To observe comprehensive physical therapy program for OSAHS patients

Detailed Description

This study proposes to conduct a randomized controlled trial ,using an APP and wearable
devices to provide comprehensive physical therapy and monitoring for people with moderate
to severe OSAHS,to assess the effectiveness and adherence of different physiotherapy
programs for patients with moderate-to-severe OSAHS by observing the improvement of sleep
apnea hypoventilation index (AHI), nocturnal minimum oxygen saturation (Low SpO2), mean
oxygen saturation (Mean SpO2), and other health outcomes in the study population. It is
expected to explore a clinical treatment pathway suitable for patients with
moderate-to-severe OSAHS through mobile app and comprehensive physical therapy, improve
the treatment adherence of OSAHS patients, enhance the level of health management
services in hospitals, and obtain more physical health and health economic benefits.

Not yet recruiting
OSAHS
Oropharyngeal Muscle Training
Aerobic Exercise
Comprehensive Physical Therapy
M-health

Behavioral: Myofunctional Therapy

Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes
Other Name: MT

Behavioral: Inspiratory Muscle Training

Respiratory muscle strengthening:inspiratory muscle strengthening by resistive loading of
50% maximum inspiratory pressure.
Other Name: IMT

Behavioral: Aerobic Exercise

Exercise intensity :40%-60% HRmax , 3-5 days/week
Other Name: AE

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Locations

Not Provided

Contacts

Yifan Wu
010-88398069
wuyifan1127@126.com

Xue Feng, Principal Investigator
Chinese Academy of Medical Sciences, Fuwai Hospital

China National Center for Cardiovascular Diseases
NCT Number
Keywords
OSAHS
Comprehensive physical therapy
M-health
MeSH Terms
Sleep Apnea Syndromes