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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Kaohsiung City, Taïwan, 82445
- Recrutement
- E-Da Hospital
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Contact:
- Chih-Chun Wang
- Numéro de téléphone: +886-988-092-216
- E-mail: CCW5969@yahoo.com.tw
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Ring-Derived Apnea-Hypopnea Index (bAHI3)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Ring-Derived Apnea-Hypopnea Index Using the 4% Desaturation Criterion (bAHI4)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AF10-008
- EMRP37113N (Autre identifiant: Institutional Review Board of E-Da Hospital)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
De-identified nightly data are available from the corresponding author on reasonable request.
Informations sur les médicaments et les dispositifs, documents d'étude
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