Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm study explores the feasibility of using a ring-type sleep monitor during a 4-week home-based submental neuromuscular electrical stimulation program for adults with obstructive sleep apnea. Participants wear the Belun Ring and receive submental stimulation to the neck area each night. The study describes changes in the ring-derived apnea-hypopnea index, sleep continuity, STOP-Bang score, and CT-based upper airway anatomy before and after training. Outcomes focus on practicality, safety, and preliminary signals of effectiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• E-Da Hospital
  Kaohsiung City, Taiwan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.