OSAHSNCT06413940
Exploring the Clinical Efficacy of Remote Management Applications Through Comprehensive Physical Therapy for Patients With Moderate to Severe Sleep Apnea
A study testing Myofunctional Therapy, Inspiratory Muscle Training and Aerobic Exercise in people with OSAHS and Oropharyngeal Muscle Training, run by China National Center for Cardiovascular Diseases.
Trial summary
To observe comprehensive physical therapy program for OSAHS patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- OSAHS, Oropharyngeal Muscle Training, Aerobic Exercise
- What is being tested?
- Myofunctional Therapy, Inspiratory Muscle Training and Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Being tested
- Myofunctional Therapy, Inspiratory Muscle Training, Aerobic Exercise
- Keywords
- OSAHS, Comprehensive physical therapy, m-health
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofunctional TherapyBehavioural
Also called MT
Oropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes
Inspiratory Muscle TrainingBehavioural
Also called IMT
Respiratory muscle strengthening:inspiratory muscle strengthening by resistive loading of 50% maximum inspiratory pressure.
Aerobic ExerciseBehavioural
Also called AE
Exercise intensity :40%-60% HRmax , 3-5 days/week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Myofunctional Therapy; Behavioral: Inspiratory Muscle Training; Behavioral: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study startMay 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAHSStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xue Feng, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413940
- Sponsor's protocol ID
- 2023-ZX036
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mobile-health and Comprehensive Physical Therapy on Moderate-to-severe Obstructive Sleep Apnea Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT06413940
- Acronym / sponsor ID
- 2023-ZX036
- Conditions
- OSAHS, Oropharyngeal Muscle Training, Aerobic Exercise, Comprehensive Physical Therapy, M-health
- Keywords
- OSAHS, Comprehensive physical therapy, m-health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- May 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Subjects in the control group will receive usual care(On-site healthy lifestyle promotion) |
| Physical therapy group | Experimental | Behavioral: Myofunctional Therapy, Behavioral: Inspiratory Muscle TrainingSubjects in the physical therapy group will receive myofunctional therapy and inspiratory muscle training |
| Combined Exercise Group | Experimental | Behavioral: Myofunctional Therapy, Behavioral: Inspiratory Muscle Training, Behavioral: Aerobic ExerciseSubjects in the combined exercise group will receive myofunctional therapy ,inspiratory muscle training and aerobic training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofunctional TherapyAlso: MTOropharyngeal and tongue exercises : strengthening upper airway muscle 20 minutes | Behavioural | Combined Exercise Group, Physical therapy group |
| Inspiratory Muscle TrainingAlso: IMTRespiratory muscle strengthening:inspiratory muscle strengthening by resistive loading of 50% maximum inspiratory pressure. | Behavioural | Combined Exercise Group, Physical therapy group |
| Aerobic ExerciseAlso: AEExercise intensity :40%-60% HRmax , 3-5 days/week | Behavioural | Combined Exercise Group |
Primary outcome
apnea-hypopnea index(AHI)
Time frame: 3 months
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
1 secondary outcome
Minimum oxygen saturation at night（Low SpO2）
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Related trials for OSAHS
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xue Feng principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Myofunctional Therapy, Inspiratory Muscle Training and Aerobic Exercise in people with OSAHS and Oropharyngeal Muscle Training, run by China National Center for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yifan Wu (010-88398069, wuyifan1127@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea-hypopnea index(AHI) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.