Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Clinical Testing of a Physiological Signal Detection, Recognition and Feedback System for Obstructive Sleep Apnea: Home-Based Submental Transcutaneous Neuromuscular Electrical Stimulation With Nightly Ring-Type Monitoring
This single-arm pilot study evaluates the feasibility of nightly wearable monitoring with a ring-type sleep monitor during a 4-week home-based program of submental transcutaneous neuromuscular electrical stimulation in adults with obstructive sleep apnea, and describes changes in the ring-derived apnea-hypopnea index, sleep continuity, STOP-Bang score and upper-airway anatomy on CT before and after training.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kaohsiung City, 대만, 82445
- 모병
- E-Da Hospital
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연락하다:
- Chih-Chun Wang
- 전화번호: +886-988-092-216
- 이메일: CCW5969@yahoo.com.tw
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults aged 20 to 65 years
- Obstructive sleep apnea diagnosed by a physician on polysomnography or an equivalent respiratory-event index test with AHI >= 5 events/h (mild 5-14.9, moderate 15-29.9, severe >= 30)
Exclusion Criteria:
- AHI < 5 events/h
- Pregnancy
- Prior nasal CPAP therapy
- Inflammation, rash, broken skin, swelling or infection at the stimulation site
- Cardiac disease, pacemaker or other implanted electronic or metallic device
- Allergic reaction to the device
- Concurrent use of other wearable medical devices (e.g., insulin pump)
- Cognitive impairment
- Suspected or confirmed epilepsy
- Central pain syndromes including headache
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Submental NMES with nightly ring monitoring
Adults with obstructive sleep apnea perform home-based submental transcutaneous neuromuscular electrical stimulation (30 minutes every evening for 28 consecutive nights) and wear a ring-type sleep monitor every night during and after training. |
Submental transcutaneous neuromuscular electrical stimulation with the RS-18 wireless low-frequency stimulator (Jie-Mai Medical Technology; TFDA license 007859; off-label use). Biphasic symmetrical pulses, 250 us, 30-100 Hz program, intensity self-titrated to a strong but comfortable contraction. One 30-minute session every evening before bedtime for 28 consecutive nights at home, after supervised instruction. A ring-type wearable sleep monitor (Belun Ring BLS-100) worn on the finger every night during the 4-week training period to record pulse oximetry, heart rate and accelerometry signals for ring-derived apnea-hypopnea index, oxygen desaturation index and sleep parameters. Used for monitoring only; no therapeutic function. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Ring-Derived Apnea-Hypopnea Index (bAHI3)
기간: Baseline (first 7 nights) and end of training (nights 22-28 or last 7 recordings)
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Change in the ring-derived apnea-hypopnea index (bAHI3, events/h) measured by a ring-type sleep monitor (Belun Ring BLS-100), comparing the mean of the first 7 nightly recordings with the mean of the last 7 nightly recordings. |
Baseline (first 7 nights) and end of training (nights 22-28 or last 7 recordings)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Ring-Derived Apnea-Hypopnea Index Using the 4% Desaturation Criterion (bAHI4)
기간: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Ring-derived apnea-hypopnea index using the 4% oxygen desaturation criterion (bAHI4, events/h) measured by a ring-type sleep monitor (Belun Ring BLS-100), comparing the mean of the first 7 valid nightly recordings with the mean of the last 7 valid nightly recordings. |
Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Change in Ring-Derived Sleep Efficiency
기간: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Ring-derived sleep efficiency (%, total sleep time divided by total recording time) measured by a ring-type sleep monitor (Belun Ring BLS-100), comparing the mean of the first 7 valid nightly recordings with the mean of the last 7 valid nightly recordings. |
Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Change in STOP-Bang Score
기간: Baseline and end of 4-week training
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STOP-Bang questionnaire score (range 0-8; higher scores indicate higher risk of obstructive sleep apnea), before vs after training. |
Baseline and end of 4-week training
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Change in Minimal Nasopharyngeal Cross-Sectional Area on Supine CT
기간: Baseline and end of 4-week training
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Minimal nasopharyngeal cross-sectional area (mm2) measured on supine computed tomography, before vs after training. |
Baseline and end of 4-week training
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Post-Training Satisfaction Score
기간: End of 4-week training
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Participant-rated satisfaction with the training program on a 0-100 scale (higher scores indicate greater satisfaction). |
End of 4-week training
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Adherence: Proportion of Nights With a Valid Ring Recording
기간: 4 weeks
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Number of nights with a valid ring-type monitor recording divided by the number of scheduled nights, expressed as a percentage. |
4 weeks
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Number of Participants With Adverse Events
기간: During the 4-week training and up to 90 days of follow-up
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Adverse events related to electrical stimulation or ring wear (e.g., skin irritation, pain, discomfort), recorded during training and follow-up. |
During the 4-week training and up to 90 days of follow-up
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Change in Ring-Derived Oxygen Desaturation Index (ODI)
기간: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Ring-derived oxygen desaturation index (events/h) measured by a ring-type sleep monitor (Belun Ring BLS-100), comparing the mean of the first 7 valid nightly recordings with the mean of the last 7 valid nightly recordings. |
Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Change in Ring-Derived Sleep-Onset Latency
기간: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Ring-derived sleep-onset latency (min) measured by a ring-type sleep monitor (Belun Ring BLS-100), comparing the mean of the first 7 valid nightly recordings with the mean of the last 7 valid nightly recordings. |
Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Change in Ring-Derived Total Sleep Time
기간: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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Ring-derived total sleep time (min) measured by a ring-type sleep monitor (Belun Ring BLS-100), comparing the mean of the first 7 valid nightly recordings with the mean of the last 7 valid nightly recordings. |
Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AF10-008
- EMRP37113N (기타 식별자: Institutional Review Board of E-Da Hospital)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified nightly data are available from the corresponding author on reasonable request.
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