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

National Center for Cardiovascular Diseases

Status: Not yet enrolling

Conditions: Oropharyngeal Muscle Training; Aerobic Exercise; Comprehensive Physical Therapy; M-health; OSAHS

Treatments: Behavioral: Aerobic Exercise; Behavioral: Myofunctional Therapy; Behavioral: Inspiratory Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06413940

2023-ZX036

Details and patient eligibility

About

To observe comprehensive physical therapy program for OSAHS patients

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

105 participants in 3 patient groups

Control group

No Intervention group

Description:

Subjects in the control group will receive usual care(On-site healthy lifestyle promotion)

Physical therapy group

Experimental group

Description:

Subjects in the physical therapy group will receive myofunctional therapy and inspiratory muscle training

Treatment:

Behavioral: Inspiratory Muscle Training

Behavioral: Myofunctional Therapy

Combined Exercise Group

Experimental group

Description:

Subjects in the combined exercise group will receive myofunctional therapy ,inspiratory muscle training and aerobic training

Treatment:

Behavioral: Inspiratory Muscle Training

Behavioral: Myofunctional Therapy

Behavioral: Aerobic Exercise