Obstructive Sleep ApneaNCT05346705
Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA
A study testing New individualized upper airway muscle functional training in people with Obstructive Sleep Apnea and Muscle Disorder, run by First Hospital of China Medical University at 1 site in China.
Trial summary
Objectives: To observe the effect of newly-created individualized upper airway muscle functional training on the condition and intraday symptoms of OSA patients; to study the effect of this training method on the excitability of the genioglossus muscle cortex; to analyze the factors affecting the efficacy of upper… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Muscle Disorder
- What is being tested?
- New individualized upper airway muscle functional training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 May 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent diagnosis of OSA (AHI>15 events/h) announced by a sleep recording
- Mean oxygen saturation >90%
- Must be able to complete the training
Who cannot join
- Inability to tolerate overnight polysomnography in sleep lab
- >50% of observed sleep apneas being central
- Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of China Medical University
Shenyang, Liaoning, 110000
Wenyang Li, PhD, 15009882216, sisy_@126.com
Wei Wang, PhD
About this study
Objectives: To observe the effect of newly-created individualized upper airway muscle functional training on the condition and intraday symptoms of OSA patients; to study the effect of this training method on the excitability of the genioglossus muscle cortex; to analyze the factors affecting the efficacy of upper airway training in the treatment of OSA and screening suitable population for upper airway training: Design: A randomized double-blind controlled trial. SAS 9.3 statistical software (SAS Institute, Cary, North Carolina, USA) was used to generate a random number table, and the selected patients were randomly divided into experimental group 1, experimental group 2, and control group according to the ratio of 1:1:1 with 100 cases each.
Unit: Shenyang, China Participants: Consecutive specific OSA patients, who are potential candidates for the treatment of upper airway training (n=300), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologists and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI<40 kg/m2).
Interventions: The three groups of subjects completed 7-day functional training and control training of upper airway muscles in different modes, respectively completed polysomnography, neck circumference, Berlin questionnaire and Epworth sleepiness scale before and after training, The genioglossus myoelectric activity was measured after transcranial magnetic stimulation and the excitability of the genioglossus cortex motor center was used to determine the efficacy of different training. After regression analysis, the factors affecting the efficacy of upper airway muscle group training were analyzed to screen the OSA patient population suitable for upper airway muscle group training.
- Conditions
- Obstructive Sleep Apnea, Muscle Disorder
- Being tested
- New individualized upper airway muscle functional training
- Medical subject headings
- Sleep Apnea, Obstructive, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New individualized upper airway muscle functional trainingBehavioural
The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Tongue/soft palate muscle control function training group | Experimental | In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor Receives: Behavioral: New individualized upper airway muscle functional training |
| Soft palate muscle group vocal resistance training group | Experimental | In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor Receives: Behavioral: New individualized upper airway muscle functional training |
| Simple tongue extension, cheek drumming/voice training group | Placebo comparator | In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor Receives: Behavioral: New individualized upper airway muscle functional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Parameters Changes : Apnea Hypopnea Index (AHI)
Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria
Measured: Baseline and 1 Week
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria
Measured: Baseline and 1 Week
Sleep Parameters Changes : Snoring index
Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria
Measured: Baseline and 1 Week
Secondary outcomes (5)
Upper Airway Muscle Strength (genioglossus)
Measurement of Genioglossus Strength Using the New Individualized Upper Airway Muscle Training Machine: Measuring Tongue Extension Strength (N)
Measured: Baseline and 1 Week
Upper Airway Muscle Strength (Soft palate muscles)
Measuring Soft Palate Muscle Strength Using the New Personalized Upper Airway Muscle Training Machine: Measuring Soft Palate Muscle Resistant Pressure (kPa)
Measured: Baseline and 1 Week
Quality of Life (as measured by Berlin Questionnaire)
The Berlin scale was used to assess the degree of risk of obstructive sleep apnea-hypopnea syndrome. The questionnaire consisted of 10 questions divided into 3 categories: snoring and apnea (5 questions); excessive daytime sleepiness or fatigue (3 questions); BMI>30 and history of hypertension. 2 or more positive results indicate a high risk of obstructive sleep apnea-hypopnea syndrome, which should be checked by the subjects, and then scored by the medical staff.
Measured: Baseline and 1 Week
Cortical motor center excitability of upper airway muscle
Measured byTranscranial Magnetic Stimulation Machine (Nihon Nkohdencorp) : amplitude (mV)
Measured: Baseline and 1 Week
Daytime sleepiness (as measured by Epworth Sleepiness Scale)
Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).
Measured: Baseline and 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenyang Li, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346705
- Sponsor's protocol ID
- AF-SOP-07-1.1-01
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be requested from researchers after the experiment is over and after the paper is published
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA
- ClinicalTrials.gov ID
- NCT05346705
- Acronym / sponsor ID
- AF-SOP-07-1.1-01
- Conditions
- Obstructive Sleep Apnea, Muscle Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 26 Apr 2022 (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.
Objectives: To observe the effect of newly-created individualized upper airway muscle functional training on the condition and intraday symptoms of OSA patients; to study the effect of this training method on the excitability of the genioglossus muscle cortex; to analyze the factors affecting the efficacy of upper airway training in the treatment of OSA and screening suitable population for upper airway training: Design: A randomized double-blind controlled trial. SAS 9.3 statistical software (SAS Institute, Cary, North Carolina, USA) was used to generate a random number table, and the selected patients were randomly divided into experimental group 1, experimental group 2, and control group according to the ratio of 1:1:1 with 100 cases each.
Unit: Shenyang, China Participants: Consecutive specific OSA patients, who are potential candidates for the treatment of upper airway training (n=300), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologists and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI<40 kg/m2).
Interventions: The three groups of subjects completed 7-day functional training and control training of upper airway muscles in different modes, respectively completed polysomnography, neck circumference, Berlin questionnaire and Epworth sleepiness scale before and after training, The genioglossus myoelectric activity was measured after transcranial magnetic stimulation and the excitability of the genioglossus cortex motor center was used to determine the efficacy of different training. After regression analysis, the factors affecting the efficacy of upper airway muscle group training were analyzed to screen the OSA patient population suitable for upper airway muscle group training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tongue/soft palate muscle control function training group | Experimental | Behavioral: New individualized upper airway muscle functional trainingIn the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor |
| Soft palate muscle group vocal resistance training group | Experimental | Behavioral: New individualized upper airway muscle functional trainingIn the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor |
| Simple tongue extension, cheek drumming/voice training group | Placebo comparator | Behavioral: New individualized upper airway muscle functional trainingIn the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recent diagnosis of OSA (AHI>15 events/h) announced by a sleep recording
- Mean oxygen saturation >90%
- Must be able to complete the training
Key exclusion criteria (3 listed)
- Inability to tolerate overnight polysomnography in sleep lab
- >50% of observed sleep apneas being central
- Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome
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 |
|---|---|---|
| New individualized upper airway muscle functional trainingThe two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days. | Behavioural | Simple tongue extension, cheek drumming/voice training group, Soft palate muscle group vocal resistance training group, Tongue/soft palate muscle control function training group |
Primary outcome
Sleep Parameters Changes : Apnea Hypopnea Index (AHI)
Time frame: Baseline and 1 Week
Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Time frame: Baseline and 1 Week
Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria
Sleep Parameters Changes : Snoring index
Time frame: Baseline and 1 Week
Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria
5 secondary outcomes
Upper Airway Muscle Strength (genioglossus)
Time frame: Baseline and 1 Week
Upper Airway Muscle Strength (Soft palate muscles)
Time frame: Baseline and 1 Week
Quality of Life (as measured by Berlin Questionnaire)
Time frame: Baseline and 1 Week
Cortical motor center excitability of upper airway muscle
Time frame: Baseline and 1 Week
Daytime sleepiness (as measured by Epworth Sleepiness Scale)
Time frame: Baseline and 1 Week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No. Data can be requested from researchers after the experiment is over and after the paper is published
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New individualized upper airway muscle functional training in people with Obstructive Sleep Apnea and Muscle Disorder, run by First Hospital of China Medical University at 1 site in China.
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 3 inclusion and 3 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Wenyang Li, PhD (15009882216, sisy_@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Parameters Changes : Apnea Hypopnea Index (AHI) (time frame: Baseline and 1 Week). The study lists 3 primary outcomes in all. 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 26 Apr 2022.