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

NCT ID: NCT06413940

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physical therapy group

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

Group Type: EXPERIMENTAL

Myofunctional Therapy

Intervention Type: BEHAVIORAL

Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes

Inspiratory Muscle Training

Intervention Type: BEHAVIORAL

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

Combined Exercise Group

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

Group Type: EXPERIMENTAL

Myofunctional Therapy

Intervention Type: BEHAVIORAL

Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes

Inspiratory Muscle Training

Intervention Type: BEHAVIORAL

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

Aerobic Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Myofunctional Therapy

Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes

Intervention Type: BEHAVIORAL

Inspiratory Muscle Training

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

Intervention Type: BEHAVIORAL

Aerobic Exercise

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

Intervention Type: BEHAVIORAL

Other Intervention Names

MT; IMT; 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xue Feng

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Central Contacts

Yifan Wu

Role: CONTACT

wuyifan1127@126.com

010-88398069

Other Identifiers

2023-ZX036

Identifier Type: -

Identifier Source: org_study_id