What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Submental transcutaneous neuromuscular electrical stimulation (RS-18), or Ring-type sleep monitor (Belun Ring BLS-100). The registry lists allocation as na. 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.
They plan to enroll about 50 people at Kaohsiung City. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
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
Interventions: Submental transcutaneous neuromuscular electrical stimulation (RS-18), Ring-type sleep monitor (Belun Ring BLS-100)
Primary outcome (registry wording): Change in Ring-Derived Apnea-Hypopnea Index (bAHI3)