Clinical trial NCT06413940: Exploring the Clinical Efficacy of Remote Management Applications Through Comprehensive Physical Therapy for Patients With Moderate to Severe Sleep Apnea
Official title: Effect of Mobile-health and Comprehensive Physical Therapy on Moderate-to-severe Obstructive Sleep Apnea Hypoventilation Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: OSAHS
Oropharyngeal Muscle Training
Aerobic Exercise
Comprehensive Physical Therapy
M-health
Keywords: OSAHS
Comprehensive physical therapy
m-health
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-05-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: apnea-hypopnea index(AHI)
timeFrame: 3 months
Secondary outcomes:
measure: Minimum oxygen saturation at night（Low SpO2）
timeFrame: 3 months
Other outcomes:
measure: Peak oxygen uptake
timeFrame: 3 months
measure: Sleep quality
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
measure: Quality of life score
timeFrame: 3 months
Locations:
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xue Feng
role: PRINCIPAL_INVESTIGATOR
References: