Obstructive Sleep ApneaNCT07921329
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
A study testing Submental transcutaneous neuromuscular electrical stimulation (RS-18) and Ring-type sleep monitor (Belun Ring BLS-100) in people with Obstructive Sleep Apnea, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Submental transcutaneous neuromuscular electrical stimulation (RS-18) and Ring-type sleep monitor (Belun Ring BLS-100)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jun 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Concurrent use of other wearable medical devices (e.g., insulin pump)
- Cognitive impairment
- Suspected or confirmed epilepsy
- Central pain syndromes including headache
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
E-Da Hospital
Kaohsiung City, 82445
Chih-Chun Wang, +886-988-092-216, CCW5969@yahoo.com.tw
About this study
Official title: 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Submental transcutaneous neuromuscular electrical stimulation (RS-18), Ring-type sleep monitor (Belun Ring BLS-100)
- Keywords
- neuromuscular electrical stimulation, wearable monitoring, apnea-hypopnea index, obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submental transcutaneous neuromuscular electrical stimulation (RS-18)Device
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.
Ring-type sleep monitor (Belun Ring BLS-100)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Submental NMES with nightly ring monitoring | Experimental | 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. Receives: Device: Submental transcutaneous neuromuscular electrical stimulation (RS-18); Device: Ring-type sleep monitor (Belun Ring BLS-100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ring-Derived Apnea-Hypopnea Index (bAHI3)
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.
Measured: Baseline (first 7 nights) and end of training (nights 22-28 or last 7 recordings)
Secondary outcomes (10)
Change in Ring-Derived Apnea-Hypopnea Index Using the 4% Desaturation Criterion (bAHI4)
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.
Measured: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Sleep Efficiency
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.
Measured: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in STOP-Bang Score
STOP-Bang questionnaire score (range 0-8; higher scores indicate higher risk of obstructive sleep apnea), before vs after training.
Measured: Baseline and end of 4-week training
Change in Minimal Nasopharyngeal Cross-Sectional Area on Supine CT
Minimal nasopharyngeal cross-sectional area (mm2) measured on supine computed tomography, before vs after training.
Measured: Baseline and end of 4-week training
Post-Training Satisfaction Score
Participant-rated satisfaction with the training program on a 0-100 scale (higher scores indicate greater satisfaction).
Measured: End of 4-week training
Adherence: Proportion of Nights With a Valid Ring Recording
Number of nights with a valid ring-type monitor recording divided by the number of scheduled nights, expressed as a percentage.
Measured: 4 weeks
Number of Participants With Adverse Events
Adverse events related to electrical stimulation or ring wear (e.g., skin irritation, pain, discomfort), recorded during training and follow-up.
Measured: During the 4-week training and up to 90 days of follow-up
Change in Ring-Derived Oxygen Desaturation Index (ODI)
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.
Measured: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Sleep-Onset Latency
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.
Measured: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Total Sleep Time
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.
Measured: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start7 Jun 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng Kung University, Metal Industries Research & Development Centre (MIRDC)
- Responsible party
- Principal investigator, Chih-Chun-Wang, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921329
- Sponsor's protocol ID
- AF10-008
- Other IDs
- EMRP37113N
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified nightly data are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07921329
- Acronym / sponsor ID
- AF10-008
- Conditions
- Obstructive Sleep Apnea
- Keywords
- neuromuscular electrical stimulation, wearable monitoring, apnea-hypopnea index, obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Collaborators
- National Cheng Kung University, Metal Industries Research & Development Centre (MIRDC)
- Study start
- 7 Jun 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Submental NMES with nightly ring monitoring | Experimental | Device: Submental transcutaneous neuromuscular electrical stimulation (RS-18), Device: Ring-type sleep monitor (Belun Ring BLS-100)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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Submental NMES with nightly ring monitoring |
| 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. | Device | Submental NMES with nightly ring monitoring |
Primary outcome
Change in Ring-Derived Apnea-Hypopnea Index (bAHI3)
Time frame: 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.
10 secondary outcomes
Change in Ring-Derived Apnea-Hypopnea Index Using the 4% Desaturation Criterion (bAHI4)
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Sleep Efficiency
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in STOP-Bang Score
Time frame: Baseline and end of 4-week training
Change in Minimal Nasopharyngeal Cross-Sectional Area on Supine CT
Time frame: Baseline and end of 4-week training
Post-Training Satisfaction Score
Time frame: End of 4-week training
Adherence: Proportion of Nights With a Valid Ring Recording
Time frame: 4 weeks
Number of Participants With Adverse Events
Time frame: During the 4-week training and up to 90 days of follow-up
Change in Ring-Derived Oxygen Desaturation Index (ODI)
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Sleep-Onset Latency
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Change in Ring-Derived Total Sleep Time
Time frame: Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided. De-identified nightly data are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submental transcutaneous neuromuscular electrical stimulation (RS-18) and Ring-type sleep monitor (Belun Ring BLS-100) in people with Obstructive Sleep Apnea, run by E-DA Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Ring-Derived Apnea-Hypopnea Index (bAHI3) (time frame: Baseline (first 7 nights) and end of training (nights 22-28 or last 7 recordings)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.