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

NCT06413940 | Not Yet Recruiting

• 1 other identifier: 2023-ZX036
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

To observe comprehensive physical therapy program for OSAHS patients

Conditions

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

Keywords

OSAHS; Comprehensive physical therapy; m-health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Minimum oxygen saturation at night（Low SpO2）

  3 months

Other Outcomes (4)

• Peak oxygen uptake

  3 months

• Sleep quality

  3 months

• Body composition

  3 months

Study Arms (3)

Control group

NO INTERVENTION

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

Physical therapy group

EXPERIMENTAL

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

Behavioral: Myofunctional Therapy; Behavioral: Inspiratory Muscle Training

Combined Exercise Group

EXPERIMENTAL

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

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

Interventions

Myofunctional Therapy BEHAVIORAL

Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes

Also known as: MT

Combined Exercise Group; Physical therapy group

Inspiratory Muscle Training BEHAVIORAL

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

Also known as: IMT

Combined Exercise Group; Physical therapy group

Aerobic Exercise BEHAVIORAL

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

Also known as: AE

Combined Exercise Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 60 years;
• 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;
• Those who have not undergone any physical therapy;
• Have some communication and comprehension skills and can use a smart phone;
• Signed informed consent.

You may not qualify if:

• BMI \> 35kg/m2;
• Patients with central and mixed sleep apnea;
• Those who use sleep aids (including benzodiazepines and non-benzodiazepine sedative-hypnotics, anxiolytics with sleep-aiding effects, antidepressants, antipsychotics) and/or nutritional supplements;
• Those suffering from acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other acute cardiovascular diseases;
• 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;
• Those with hypothyroidism;
• 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;
• Those with inflammation-related systemic diseases (e.g., arthritis, tuberculosis, vasculitis, lupus);
• 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;
• Those who smoke and drink alcohol;
• 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;
• Ongoing clinical trials of drugs or devices in which they are participating;
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Myofunctional Therapy; Exercise

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Xue Feng

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Wu

CONTACT

010-88398069; wuyifan1127@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 14, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-04