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Clinical Trials in Taiwan / NCT07921329
Recruiting Not applicable

Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea

NCT07921329 · tracked via the Priya Life Science Taiwan tracker
Sponsor
E-DA Hospital
Phase
Not applicable
Started
2025-06-07
Last updated
2026-11-06

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Submental transcutaneous neuromuscular electrical stimulation (RS-18)Ring-type sleep monitor (Belun Ring BLS-100)

Submental transcutaneous neuromuscular electrical stimulation (RS-18): 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.

Ring-type sleep monitor (Belun Ring BLS-100): 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Ring-Derived Apnea-Hypopnea Index (bAHI3) — Baseline (first 7 nights) and end of training (nights 22-28 or last 7 recordings)
    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.

Trial sites (1)

FacilityCityRegionStatus
E-Da Hospital Kaohsiung City Taiwan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07921329 on ClinicalTrials.gov ↗ ← All trials in Taiwan