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

2 november 2026 uppdaterad av: Chih-Chun-Wang, E-DA Hospital

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Taiwan
      • Kaohsiung City, Taiwan, 82445
        • Rekrytering
        • E-Da Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Enhet: 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.

Enhet: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Ring-Derived Apnea-Hypopnea Index Using the 4% Desaturation Criterion (bAHI4)
Tidsram: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks

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
Change in Ring-Derived Sleep Efficiency
Tidsram: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks

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
Change in STOP-Bang Score
Tidsram: Baseline and end of 4-week training

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
Change in Minimal Nasopharyngeal Cross-Sectional Area on Supine CT
Tidsram: Baseline and end of 4-week training

Minimal nasopharyngeal cross-sectional area (mm2) measured on supine computed tomography, before vs after training.
Baseline and end of 4-week training
Post-Training Satisfaction Score
Tidsram: End of 4-week training

Participant-rated satisfaction with the training program on a 0-100 scale (higher scores indicate greater satisfaction).
End of 4-week training
Adherence: Proportion of Nights With a Valid Ring Recording
Tidsram: 4 weeks

Number of nights with a valid ring-type monitor recording divided by the number of scheduled nights, expressed as a percentage.
4 weeks
Number of Participants With Adverse Events
Tidsram: During the 4-week training and up to 90 days of follow-up

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
Change in Ring-Derived Oxygen Desaturation Index (ODI)
Tidsram: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks

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
Change in Ring-Derived Sleep-Onset Latency
Tidsram: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks

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
Change in Ring-Derived Total Sleep Time
Tidsram: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

E-DA Hospital

Samarbetspartners

National Cheng Kung University
Metal Industries Research & Development Centre (MIRDC)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 juni 2025

Primärt slutförande (Beräknad)

1 januari 2028

Avslutad studie (Beräknad)

1 januari 2028

Studieregistreringsdatum

Först inskickad

2 november 2026

Först inskickad som uppfyllde QC-kriterierna

2 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AF10-008
  • EMRP37113N (Annan identifierare: Institutional Review Board of E-Da Hospital)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

De-identified nightly data are available from the corresponding author on reasonable request.

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