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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kaohsiung City, Taiwan, 82445
- Reclutamento
- E-Da Hospital
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Contatto:
- Chih-Chun Wang
- Numero di telefono: +886-988-092-216
- Email: CCW5969@yahoo.com.tw
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Ring-Derived Apnea-Hypopnea Index (bAHI3)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Ring-Derived Apnea-Hypopnea Index Using the 4% Desaturation Criterion (bAHI4)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AF10-008
- EMRP37113N (Altro identificatore: Institutional Review Board of E-Da Hospital)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
De-identified nightly data are available from the corresponding author on reasonable request.
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