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Prescision Medicine in Obstructive Sleep Apnea, Cardiovascular and Cerebrovascular Disease: AI Electrocardiogram Patch Does it All

Primary Purpose

Sleep Apnea, Obstructive

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Positional Therapy
Intraoral Negative Pressure Therapy
Oral Appliances
Surgery
Tongue Muscle Strength Training
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients with snoring and obstructive sleep apnea

Exclusion Criteria:

Patients who are not suitable for anesthesia and surgical risks, including:

  • serious cerebrovascular and cardiovascular diseases
  • serious metabolic disorders
  • serious respiratory diseases

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

BMI <27

BMI 27-32

BMI >32

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Home Sleep Test (HST)
recording time (start, end), AHI, AHI supine, AHI non-supine, events totals (apnea, hypopnea), AI obstructive, ODI, lowest oxygen saturation
Polysomnography (PSG)
AHI, REM AHI, total sleep time, events totals (obstructive apnea, hypopnea), lowest oxygen saturation, PLM index, ESS

Full Information

First Posted
September 22, 2022
Last Updated
September 29, 2022
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
National Yang Ming Chiao Tung University
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1. Study Identification

Unique Protocol Identification Number
NCT05566860
Brief Title
Prescision Medicine in Obstructive Sleep Apnea, Cardiovascular and Cerebrovascular Disease: AI Electrocardiogram Patch Does it All
Official Title
Prescision Medicine in Obstructive Sleep Apnea, Cardiovascular and Cerebrovascular Disease: AI Electrocardiogram Patch Does it All
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborators
National Yang Ming Chiao Tung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BMI <27
Arm Type
Experimental
Arm Title
BMI 27-32
Arm Type
Experimental
Arm Title
BMI >32
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Positional Therapy
Intervention Description
After the a forementioned sleep endoscopy, if the patient has postural sleep apnea, he was treated with positional therapy for three months.
Intervention Type
Procedure
Intervention Name(s)
Intraoral Negative Pressure Therapy
Other Intervention Name(s)
iNAP
Intervention Description
If the patient is effective with intraoral negative pressure therapy (iNAP), this therapy was used for three months.
Intervention Type
Procedure
Intervention Name(s)
Oral Appliances
Intervention Description
If the patient is effective with oral appliances use, it was used be for three months.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tongue Muscle Strength Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
single-lead ECG monitoring patch with 3-axis ac-celerometer
Description
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)
Time Frame
The ECG patches will track changes before and three months after treatment.
Secondary Outcome Measure Information:
Title
Home Sleep Test (HST)
Description
recording time (start, end), AHI, AHI supine, AHI non-supine, events totals (apnea, hypopnea), AI obstructive, ODI, lowest oxygen saturation
Time Frame
The HST will track changes before and three months after treatment.
Title
Polysomnography (PSG)
Description
AHI, REM AHI, total sleep time, events totals (obstructive apnea, hypopnea), lowest oxygen saturation, PLM index, ESS
Time Frame
The PSG test will track changes before and three months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with snoring and obstructive sleep apnea Exclusion Criteria: Patients who are not suitable for anesthesia and surgical risks, including: serious cerebrovascular and cardiovascular diseases serious metabolic disorders serious respiratory diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying-Shuo Hsu
Phone
00886918361831
Email
sulisky@gmail.com
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Prescision Medicine in Obstructive Sleep Apnea, Cardiovascular and Cerebrovascular Disease: AI Electrocardiogram Patch Does it All

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