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

Not Applicable

Recruiting

• Conditions: Sleep Apnea, Obstructive
• Interventions: Procedure: Positional Therapy; Procedure: Intraoral Negative Pressure Therapy; Procedure: Oral Appliances; Procedure: Surgery; Procedure: Tongue Muscle Strength Training

• Registration Number: NCT05566860
• Lead Sponsor: Shin Kong Wu Ho-Su Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Status Verified: 2022-09
• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-29
• Last Update Submitted: 2022-09-29
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Primary Completion: 2023-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BMI <27	Intraoral Negative Pressure Therapy	-
BMI 27-32	Oral Appliances	-
BMI <27	Positional Therapy	-
BMI <27	Surgery	-
BMI <27	Tongue Muscle Strength Training	-
BMI 27-32	Surgery	-
BMI <27	Oral Appliances	-
BMI 27-32	Positional Therapy	-
BMI >32	Positional Therapy	-
BMI >32	Intraoral Negative Pressure Therapy	-
BMI >32	Tongue Muscle Strength Training	-
BMI 27-32	Intraoral Negative Pressure Therapy	-
BMI >32	Oral Appliances	-
BMI >32	Surgery	-
BMI 27-32	Tongue Muscle Strength Training	-

Primary Outcome Measures

Name	Time	Method
single-lead ECG monitoring patch with 3-axis ac-celerometer	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)

Secondary Outcome Measures

Name	Time	Method
Home Sleep Test (HST)	The HST will track changes before and three months after treatment.	recording time (start, end), AHI, AHI supine, AHI non-supine, events totals (apnea, hypopnea), AI obstructive, ODI, lowest oxygen saturation
Polysomnography (PSG)	The PSG test will track changes before and three months after treatment.	AHI, REM AHI, total sleep time, events totals (obstructive apnea, hypopnea), lowest oxygen saturation, PLM index, ESS

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan