Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
NCT07921329, Not applicable, Recruiting, E-DA Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea | ClinicalTrials.gov |
| NCT number | NCT07921329 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | E-DA Hospital | ClinicalTrials.gov |
| Conditions | Obstructive Sleep Apnea | ClinicalTrials.gov |
| Interventions | Submental transcutaneous neuromuscular electrical stimulation (RS-18), Ring-type sleep monitor (Belun Ring BLS-100) | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Ring-Derived Apnea-Hypopnea Index (bAHI3) | 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. | ClinicalTrials.gov |
| Secondary | Change in Ring-Derived Apnea-Hypopnea Index Using the 4% Desaturation Criterion (bAHI4) | Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in Ring-Derived Sleep Efficiency | Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in STOP-Bang Score | Baseline and end of 4-week training | STOP-Bang questionnaire score (range 0-8; higher scores indicate higher risk of obstructive sleep apnea), before vs after training. | ClinicalTrials.gov |
| Secondary | Change in Minimal Nasopharyngeal Cross-Sectional Area on Supine CT | Baseline and end of 4-week training | Minimal nasopharyngeal cross-sectional area (mm2) measured on supine computed tomography, before vs after training. | ClinicalTrials.gov |
| Secondary | Post-Training Satisfaction Score | End of 4-week training | Participant-rated satisfaction with the training program on a 0-100 scale (higher scores indicate greater satisfaction). | ClinicalTrials.gov |
| Secondary | Adherence: Proportion of Nights With a Valid Ring Recording | 4 weeks | Number of nights with a valid ring-type monitor recording divided by the number of scheduled nights, expressed as a percentage. | ClinicalTrials.gov |
| Secondary | Number of Participants With Adverse Events | During the 4-week training and up to 90 days of follow-up | Adverse events related to electrical stimulation or ring wear (e.g., skin irritation, pain, discomfort), recorded during training and follow-up. | ClinicalTrials.gov |
| Secondary | Change in Ring-Derived Oxygen Desaturation Index (ODI) | Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in Ring-Derived Sleep-Onset Latency | Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks | 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. | ClinicalTrials.gov |
| Secondary | Change in Ring-Derived Total Sleep Time | Baseline (first 7 valid nights) and end of training (last 7 valid nights), 4 weeks | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)