Sleep Apnea, ObstructiveNCT05566860
Prescision Medicine in Obstructive Sleep Apnea, Cardiovascular and Cerebrovascular Disease: AI Electrocardiogram Patch Does it All
A study testing Positional Therapy, Intraoral Negative Pressure Therapy and Oral Appliances in people with Sleep Apnea, Obstructive, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
Obstructive Sleep apnea(OSA) is a disease with multiple causes, and treatments are very diverse. Patients and doctors have a lot of choices. The concept of precision medicine is needed to intervene so that doctors and patients can have directions in this huge map and won't get lost. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Positional Therapy, Intraoral Negative Pressure Therapy and Oral Appliances
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jun 2022to 31 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with snoring and obstructive sleep apnea
Who cannot join
- Patients who are not suitable for anesthesia and surgical risks, including:
- serious cerebrovascular and cardiovascular diseases
- serious metabolic disorders
- serious respiratory diseases
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
About this study
Obstructive Sleep apnea(OSA) is a disease with multiple causes, and treatments are very diverse. Patients and doctors have a lot of choices. The concept of precision medicine is needed to intervene so that doctors and patients can have directions in this huge map and won't get lost. In this OSA maze, we have already walked through some feasible passages, but we are far from reaching the end.
At present, the research direction of artificial intelligence for OSA is mostly focused on how to accurately screen, but less attention is paid on how to accurately treat and conveniently follow the effectiveness of treatment to increase patient compliance.
Read more
We can already analyze the results of electrocardiogram patches to predict the severity of sleep apnea. We have also been able to analyze the results of electrocardiogram patches for three consecutive nights, and found postural sleep apnea that could not be detected in laboratory sleep examinations, and help doctors provide appropriate intervention to improve patients' sleep apnea, severity and quality of sleep. We have also found that precision sleep endoscopy can be used to predict the outcome of sleep apnea patients after surgery and the effectiveness of treatment with an intraoral nagative airway pressure device.
Therefore, in the future, with artificial intelligence(AI), ECG patches are able to be used for follow patients' treatment effectiveness.
Others include the treatment of weight loss drugs and bariatric surgery for obese patients, the control of environmental temperature and humidity, and the training of oropharyngeal and tongue muscle strength, all of which require the diagnosis and follow up of AI ECG patches from beginning to end.
According to the latest research, nocturnal hypertension is more relevant to the prognosis of cardiovascular problems and cerebrovascular disease that may occur in the future. This is also the problem that we are most concerned about in the treatment of sleep apnea. ECG patches also have the potential to provide us with information about nocturnal hypertension. Studies have also shown that ECG patches test results are highly correlated with nocturnal hypertension. Therefore, the improvement of nocturnal hypertension can also be used as an important indicator of the effectiveness for our treatment of sleep apnea.
Therefore, the goal of this project is to develop AI algorithm to make ECG patches more helpful to patients with sleep apnea, and to make better treatment decisions that are most suitable for patients, such as postural therapy, bariatric surgery for obese patients, environmental temperature and humidity control, oropharyngeal tongue muscle strength training, and accompany with sleep endoscope for the selection of intraoral negative pressure devices and surgery, and finally use AI ECG patches for the patient for three consecutive nights to evaluate the improvement of nocturnal hypertension and sleep apnea, and to achieve the goal of precision medicine in OSA.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Positional Therapy, Intraoral Negative Pressure Therapy, Oral Appliances, Surgery, Tongue Muscle Strength Training
- Keywords
- obstructive sleep apnea, ECG patch, precision medicine, cardiovascular disease, cerebrovascular disease, sleep environment, sleep endoscope, postural therapy, oral appliance, intraoral negative airway pressure, sleep surgery, obesity, bariatric surgery
- Medical subject headings
- Sleep Apnea, Obstructive, Cardiovascular Diseases, Cerebrovascular Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positional TherapyProcedure or surgery
After the a forementioned sleep endoscopy, if the patient has postural sleep apnea, he was treated with positional therapy for three months.
Intraoral Negative Pressure TherapyProcedure or surgery
Also called iNAP
If the patient is effective with intraoral negative pressure therapy (iNAP), this therapy was used for three months.
Oral AppliancesProcedure or surgery
If the patient is effective with oral appliances use, it was used be for three months.
SurgeryProcedure or surgery
If the interventions mentioned above are ineffective, or the patient does not want to try the above treatments, surgery is required. The surgical patients were divided into three groups according to their body weight. One group was overweight patients (BMI>32) who were treated with upper airway surgery and/or bariatric surgery, and/or postoperative diet education; the other group was overweight people with a BMI between 27 and 32, upper airway surgery and/or bariatric surgery, and/or postoperative diet education will be done; if the weight is normal with the BMI is less than 27, or those patients who are overweight but are not willing receive above mentioned weight loss treatment, upper airway surgery will be done.
Tongue Muscle Strength TrainingProcedure or surgery
If the tongue strength of the aforementioned patient is insufficient, it is recommended that the patient need to do tongue muscle strength training at the same time for three months. If the ambient temperature and humidity have an impact, we will recommend patients to control the ambient temperature and humidity and use the ECG patch to track the changes before and after three months.
| Study group | Role | What they receive |
|---|---|---|
| BMI <27 | Experimental | Not described Receives: Procedure: Positional Therapy; Procedure: Intraoral Negative Pressure Therapy; Procedure: Oral Appliances; Procedure: Surgery; Procedure: Tongue Muscle Strength Training |
| BMI 27-32 | Experimental | Not described Receives: Procedure: Positional Therapy; Procedure: Intraoral Negative Pressure Therapy; Procedure: Oral Appliances; Procedure: Surgery; Procedure: Tongue Muscle Strength Training |
| BMI >32 | Experimental | Not described Receives: Procedure: Positional Therapy; Procedure: Intraoral Negative Pressure Therapy; Procedure: Oral Appliances; Procedure: Surgery; Procedure: Tongue Muscle Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
single-lead ECG monitoring patch with 3-axis ac-celerometer
total record time, total sleep time, sleep efficiency, sleep latency, wake after sleep onset, ECG-derived respiration, cyclic variation of heart rate, heart rate variability (mean HR, SD, TP, HF, LF, VL, Kurtosis, Skewness)
Measured: The ECG patches will track changes before and three months after treatment.
Secondary outcomes (2)
Home Sleep Test (HST)
recording time (start, end), AHI, AHI supine, AHI non-supine, events totals (apnea, hypopnea), AI obstructive, ODI, lowest oxygen saturation
Measured: The HST will track changes before and three months after treatment.
Polysomnography (PSG)
AHI, REM AHI, total sleep time, events totals (obstructive apnea, hypopnea), lowest oxygen saturation, PLM index, ESS
Measured: The PSG test will track changes before and three months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start23 Jun 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566860
- Sponsor's protocol ID
- 20220111R
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescision Medicine in Obstructive Sleep Apnea, Cardiovascular and Cerebrovascular Disease: AI Electrocardiogram Patch Does it All
- ClinicalTrials.gov ID
- NCT05566860
- Acronym / sponsor ID
- 20220111R
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- obstructive sleep apnea, ECG patch, precision medicine, cardiovascular disease, cerebrovascular disease, sleep environment, sleep endoscope, postural therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Oct 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.
Obstructive Sleep apnea(OSA) is a disease with multiple causes, and treatments are very diverse. Patients and doctors have a lot of choices. The concept of precision medicine is needed to intervene so that doctors and patients can have directions in this huge map and won't get lost. In this OSA maze, we have already walked through some feasible passages, but we are far from reaching the end.
At present, the research direction of artificial intelligence for OSA is mostly focused on how to accurately screen, but less attention is paid on how to accurately treat and conveniently follow the effectiveness of treatment to increase patient compliance.
We can already analyze the results of electrocardiogram patches to predict the severity of sleep apnea. We have also been able to analyze the results of electrocardiogram patches for three consecutive nights, and found postural sleep apnea that could not be detected in laboratory sleep examinations, and help doctors provide appropriate intervention to improve patients' sleep apnea, severity and quality of sleep. We have also found that precision sleep endoscopy can be used to predict the outcome of sleep apnea patients after surgery and the effectiveness of treatment with an intraoral nagative airway pressure device.
Therefore, in the future, with artificial intelligence(AI), ECG patches are able to be used for follow patients' treatment effectiveness.
Others include the treatment of weight loss drugs and bariatric surgery for obese patients, the control of environmental temperature and humidity, and the training of oropharyngeal and tongue muscle strength, all of which require the diagnosis and follow up of AI ECG patches from beginning to end.
According to the latest research, nocturnal hypertension is more relevant to the prognosis of cardiovascular problems and cerebrovascular disease that may occur in the future. This is also the problem that we are most concerned about in the treatment of sleep apnea. ECG patches also have the potential to provide us with information about nocturnal hypertension. Studies have also shown that ECG patches test results are highly correlated with nocturnal hypertension. Therefore, the improvement of nocturnal hypertension can also be used as an important indicator of the effectiveness for our treatment of sleep apnea.
Therefore, the goal of this project is to develop AI algorithm to make ECG patches more helpful to patients with sleep apnea, and to make better treatment decisions that are most suitable for patients, such as postural therapy, bariatric surgery for obese patients, environmental temperature and humidity control, oropharyngeal tongue muscle strength training, and accompany with sleep endoscope for the selection of intraoral negative pressure devices and surgery, and finally use AI ECG patches for the patient for three consecutive nights to evaluate the improvement of nocturnal hypertension and sleep apnea, and to achieve the goal of precision medicine in OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI <27 | Experimental | Procedure: Positional Therapy, Procedure: Intraoral Negative Pressure Therapy, Procedure: Oral Appliances, Procedure: Surgery, Procedure: Tongue Muscle Strength Training |
| BMI 27-32 | Experimental | Procedure: Positional Therapy, Procedure: Intraoral Negative Pressure Therapy, Procedure: Oral Appliances, Procedure: Surgery, Procedure: Tongue Muscle Strength Training |
| BMI >32 | Experimental | Procedure: Positional Therapy, Procedure: Intraoral Negative Pressure Therapy, Procedure: Oral Appliances, Procedure: Surgery, Procedure: Tongue Muscle Strength Training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with snoring and obstructive sleep apnea
Key exclusion criteria (4 listed)
- serious cerebrovascular and cardiovascular diseases
- serious metabolic disorders
- serious respiratory diseases
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 |
|---|---|---|
| Positional TherapyAfter the a forementioned sleep endoscopy, if the patient has postural sleep apnea, he was treated with positional therapy for three months. | Procedure or surgery | BMI 27-32, BMI <27, BMI >32 |
| Intraoral Negative Pressure TherapyAlso: iNAPIf the patient is effective with intraoral negative pressure therapy (iNAP), this therapy was used for three months. | Procedure or surgery | BMI 27-32, BMI <27, BMI >32 |
| Oral AppliancesIf the patient is effective with oral appliances use, it was used be for three months. | Procedure or surgery | BMI 27-32, BMI <27, BMI >32 |
| SurgeryIf the interventions mentioned above are ineffective, or the patient does not want to try the above treatments, surgery is required. The surgical patients were divided into three groups according to their body weight. One group was overweight patients (BMI>32) who were treated with upper airway surgery and/or bariatric surgery, and/or postoperative diet education; the other group was overweight people with a BMI between 27 and 32, upper airway surgery and/or bariatric surgery, and/or postoperative diet education will be done; if the weight is normal with the BMI is less than 27, or those patients who are overweight but are not willing receive above mentioned weight loss treatment, upper airway surgery will be done. | Procedure or surgery | BMI 27-32, BMI <27, BMI >32 |
| Tongue Muscle Strength TrainingIf the tongue strength of the aforementioned patient is insufficient, it is recommended that the patient need to do tongue muscle strength training at the same time for three months. If the ambient temperature and humidity have an impact, we will recommend patients to control the ambient temperature and humidity and use the ECG patch to track the changes before and after three months. | Procedure or surgery | BMI 27-32, BMI <27, BMI >32 |
Primary outcome
single-lead ECG monitoring patch with 3-axis ac-celerometer
Time frame: The ECG patches will track changes before and three months after treatment.
total record time, total sleep time, sleep efficiency, sleep latency, wake after sleep onset, ECG-derived respiration, cyclic variation of heart rate, heart rate variability (mean HR, SD, TP, HF, LF, VL, Kurtosis, Skewness)
2 secondary outcomes
Home Sleep Test (HST)
Time frame: The HST will track changes before and three months after treatment.
Polysomnography (PSG)
Time frame: The PSG test will track changes before and three months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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 Positional Therapy, Intraoral Negative Pressure Therapy and Oral Appliances in people with Sleep Apnea, Obstructive, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 4 Oct 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 Taiwan. 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. 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 Ying-Shuo Hsu (00886918361831, sulisky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
single-lead ECG monitoring patch with 3-axis ac-celerometer (time frame: The ECG patches will track changes before and three months after treatment.). 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 4 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.