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

Aerobic Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413940
• Other study ID #: 2023-ZX036
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: Yifan Wu
• Phone: 010-88398069
• Email: wuyifan1127[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To observe comprehensive physical therapy program for OSAHS patients

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 105
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aerobic Exercise
• M-health
• OSAHS
• Sleep Apnea Syndromes

Intervention

Behavioral:
• Myofunctional Therapy
Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes
• Inspiratory Muscle Training
Respiratory muscle strengthening:inspiratory muscle strengthening by resistive loading of 50% maximum inspiratory pressure.
• Aerobic Exercise
Exercise intensity :40%-60% HRmax , 3-5 days/week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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