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

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

To observe comprehensive physical therapy program for OSAHS patients

Study Overview

• Status: Not yet recruiting
• Conditions: Aerobic Exercise; M-health; OSAHS; Oropharyngeal Muscle Training; Comprehensive Physical Therapy
• Intervention / Treatment: Behavioral: Myofunctional Therapy; Behavioral: Inspiratory Muscle Training; Behavioral: Aerobic Exercise

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yifan Wu; Phone Number: 010-88398069; Email: wuyifan1127@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Subjects in the control group will receive usual care(On-site healthy lifestyle promotion)
Experimental: Physical therapy group; Subjects in the physical therapy group will receive myofunctional therapy and inspiratory muscle training	Behavioral: Myofunctional Therapy; Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes; Other Names: MT; Behavioral: Inspiratory Muscle Training; Respiratory muscle strengthening:inspiratory muscle strengthening by resistive loading of 50% maximum inspiratory pressure.; Other Names: IMT
Experimental: Combined Exercise Group; Subjects in the combined exercise group will receive myofunctional therapy ,inspiratory muscle training and aerobic training	Behavioral: Myofunctional Therapy; Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes; Other Names: MT; Behavioral: Inspiratory Muscle Training; Respiratory muscle strengthening:inspiratory muscle strengthening by resistive loading of 50% maximum inspiratory pressure.; Other Names: IMT; Behavioral: Aerobic Exercise; Exercise intensity :40%-60% HRmax , 3-5 days/week; Other Names: AE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
apnea-hypopnea index(AHI)	The home sleep apnea test (HSAT) device was used to detect the AHI of OSAHS patients, and the AHI was defined as the average number of apneas or hypoventilation per hour during sleep. According to the guidelines and related literature grouping,AHI ≥ 5 times/h was diagnosed as OSAHS, 5 times/h ≤ AHI < 15 times/h as mild OSAHS, and AHI ≥ 15 times/h as moderate to severe OSAHS. Our study observe the changes in apnea-hypopnea index from baseline to 3 months	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimum oxygen saturation at night（Low SpO2）	The home sleep apnea test (HSAT) device was used to detect the Low SpO2 of OSAHS patients. Our study observe the changes in Low SpO2 from baseline to 3 months.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen uptake	Our study observe the changes in cardiorespiratory function from baseline to 3 months.In this program, a cycling graded incremental exercise program (Ramp program) was used, peak oxygen uptake was monitored.	3 months
Sleep quality	Changes in sleep quality from baseline to 3 months. The sleep quality was assessed by the Pittsburgh Sleep Quality Index (PSQI) .The scoring criteria are: 0-5 for very good sleep quality, 6-10 for okay sleep quality, 11-15 for average sleep quality, and 16-21 for very poor sleep quality, with higher total scores indicating poorer sleep quality;	3 months
Body composition	Changes in body composition analysis from baseline to 3 months.Using bioelectrical impedance analysis to monitor body weight,weight and height will be combined to report BMI in kg/m^2.	3 months
Quality of life score	Changes in quality of life from baseline to 3 months.Quality of life was assessed using the short form 36 questionnaire (SF-36).The score is 0-100, with higher scores indicating higher quality of patient survival.	3 months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xue Feng, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: OSAHS; m-health; Comprehensive physical therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: 2023-ZX036

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No