An interventional study of Submental transcutaneous neuromuscular electrical stimulation (RS-18) and Ring-type sleep monitor (Belun Ring BLS-100) in Obstructive Sleep Apnea, sponsored by E-DA Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by E-DA Hospital · Not applicable, Interventional, and Treatment
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 50 is close to the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
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Exclusion Criteria:
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.
Device: Submental transcutaneous neuromuscular electrical stimulation (RS-18) · Device: Ring-type sleep monitor (Belun Ring BLS-100)
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.
Change in Ring-Derived Apnea-Hypopnea Index (bAHI3)
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.
Time frame: Baseline (first 7 nights) and end of training (nights 22-28 or last 7 recordings)
Change in Ring-Derived Apnea-Hypopnea Index Using the 4% Desaturation Criterion (bAHI4)
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.
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Sleep Efficiency
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.
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in STOP-Bang Score
STOP-Bang questionnaire score (range 0-8; higher scores indicate higher risk of obstructive sleep apnea), before vs after training.
Time frame: Baseline and end of 4-week training
Change in Minimal Nasopharyngeal Cross-Sectional Area on Supine CT
Minimal nasopharyngeal cross-sectional area (mm2) measured on supine computed tomography, before vs after training.
Time frame: Baseline and end of 4-week training
Post-Training Satisfaction Score
Participant-rated satisfaction with the training program on a 0-100 scale (higher scores indicate greater satisfaction).
Time frame: End of 4-week training
Adherence: Proportion of Nights With a Valid Ring Recording
Number of nights with a valid ring-type monitor recording divided by the number of scheduled nights, expressed as a percentage.
Time frame: 4 weeks
Number of Participants With Adverse Events
Adverse events related to electrical stimulation or ring wear (e.g., skin irritation, pain, discomfort), recorded during training and follow-up.
Time frame: During the 4-week training and up to 90 days of follow-up
Change in Ring-Derived Oxygen Desaturation Index (ODI)
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.
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Sleep-Onset Latency
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.
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Total Sleep Time
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.
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Plan to share: Undecided — De-identified nightly data are available from the corresponding author on reasonable request.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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E-DA Hospital