Obstructive Sleep ApneaNCT07785999
CES-EES Clinical Score and a Wearable Ring Sensor for Obstructive Sleep Apnea: Individual and Combined Validation Against In-Laboratory Polysomnography
An observational study of Obstructive Sleep Apnea, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study evaluates whether a clinical upper airway assessment tool (the Clinical Examination Score plus ENT Examination Score, CES-EES) and an artificial-intelligence wearable ring (Belun Ring, Belun Sleep System BLS-100) can serve as accurate, less resource-intensive alternatives to in-lab polysomnography (PSG) for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Belun Ring (Belun Sleep System BLS-100) and CES-EES Clinical Scoring
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 58 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2026to 1 Mar 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults referred to the UMMC Otorhinolaryngology sleep clinic for sleep-related breathing disorders and scheduled for in-lab PSG
Who may be able to join
- ≥18 years old
- Patients with suspected OSA (high ESS and/or STOP-BANG score)
- CES-EES score 4 or more
- Newly diagnosed cases
- Minimum 4 hours of Total Sleep Time (TST)
Who cannot join
- Active URTI (upper respiratory tract infection) in the past 1 month
- Current smoker
- Alcohol consumption within 8 hours prior to testing
- History of head and neck carcinoma
- Active respiratory or neurological disorders
- Active psychiatric disorders and currently on psychiatric medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Associate Professor Dr. Goh Liang Chye, MBBS contact
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Malaya Medical Centre (UMMC)
Pantai Valley, Kuala Lumpur, 59100
Varatha Raju Kugan, MD
Liang Chye Goh, MBBS
About this study
Official title: Validation of Clinical Upper Airway Assessment Tool With Artificial Intelligence Wearable Technology Against In-Lab Polysomnography
This study evaluates whether a clinical upper airway assessment tool (the Clinical Examination Score plus ENT Examination Score, CES-EES) and an artificial-intelligence wearable ring (Belun Ring, Belun Sleep System BLS-100) can serve as accurate, less resource-intensive alternatives to in-lab polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA). Adults referred to the Otorhinolaryngology sleep clinic at Universiti Malaya Medical Centre (UMMC) for suspected OSA, who score 4 or more on the combined CES-EES scale, undergo a single overnight Level 1 in-lab PSG. The Belun Ring is worn concurrently with standard PSG electrodes during this same overnight study. The apnea-hypopnea index (AHI) from the Belun Ring and the CES-EES score, individually and in combination, are compared against the AHI from in-lab PSG -- the diagnostic reference standard -- to assess their agreement, correlation, and diagnostic accuracy for OSA.
Read the detailed description
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder associated with cardiovascular, cerebrovascular, and other long-term health consequences if untreated. In-lab polysomnography (PSG) is the diagnostic reference standard but is resource-intensive, costly, and associated with long waiting times. Existing screening tools such as the STOP-BANG questionnaire and the Epworth Sleepiness Scale (ESS) have recognized sensitivity/specificity trade-offs. The Clinical Examination Score (CES) combined with the ENT Examination Score (EES) is a previously described clinical scoring tool for OSA screening. The Belun Ring (Belun Sleep System BLS-100) is an FDA 510(k)-cleared (Class II), Malaysia Medical Device Authority-registered, AI/deep-learning-facilitated wearable capable of estimating AHI, sleep staging, and OSA severity.
This is a prospective, comparative, single-centre study conducted at Universiti Malaya Medical Centre (UMMC). Adults referred to the Otorhinolaryngology sleep clinic for suspected OSA, with high ESS and/or STOP-BANG scores, are screened with the CES-EES; those scoring 4 or more and otherwise meeting eligibility criteria are enrolled. After informed consent, participants undergo a standardised history, demographic data collection, and physical examination (oral cavity examination, flexible nasopharyngeal endoscopy, dental assessment), followed by a single overnight Level 1 in-lab PSG (Compumedics, 7-channel) at the UMMC Neurology Sleep Lab. The Belun Ring is fitted to the participant's index finger concurrently with standard PSG electrodes, so both devices record simultaneously during the same overnight study. A minimum of 4 hours total sleep time (TST) is required; participants with less than 4 hours TST are excluded from analysis. Both PSG and Belun Ring AHI are scored using AASM 1A criteria (hypopnea defined by desaturation of 3% or more). PSG is manually scored by a sleep technician; Belun Ring output is processed by the device's AI algorithm and independently cross-checked by two investigators.
The primary comparisons are: (1) CES-EES score against PSG AHI; (2) Belun Ring AHI against PSG AHI; and (3) CES-EES combined with Belun Ring AHI against PSG AHI. Planned statistical analyses include the paired t-test or Wilcoxon signed-rank test for comparative analysis, Bland-Altman plots for agreement/bias analysis, the intraclass correlation coefficient (ICC) for inter-scorer reliability, and descriptive statistics (mean, median, SD, range).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Belun Ring (Belun Sleep System BLS-100), CES-EES Clinical Scoring
- Keywords
- obstructive sleep apnea, sleep parameters, polysomnography, wearable device, diagnostic accuracy
- 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.
Belun Ring (Belun Sleep System BLS-100)Device
AI/deep-learning-facilitated wearable ring worn on the index finger concurrently with standard PSG electrodes during the overnight PSG study; estimates AHI, sleep stages, and OSA severity using AASM 1A scoring criteria (desaturation of 3% or more defines hypopnea).
CES-EES Clinical ScoringOther
Combined Clinical Examination Score (CES) and ENT Examination Score (EES), administered via history, oral cavity examination, flexible nasopharyngeal endoscopy, and dental assessment prior to PSG.
| Study group | Role | What they receive |
|---|---|---|
| Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab P | Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab PSG Receives: Device: Belun Ring (Belun Sleep System BLS-100); Other: CES-EES Clinical Scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
AHI (events/hour) derived from polysomnogram or wearable sleep study, scored using AASM 1A criteria (desaturation of 3% or more defines hypopnea); output cross-checked by two independent investigators.
Measured: Baseline
Secondary outcomes (2)
Sleep quality parameters
Total sleep time (TST), sleep latency, wake after sleep onset (WASO), sleep efficiency, and lowest oxygen saturation (LSAT)
Measured: Baseline
Epworth Sleepiness Scale (ESS) score
Self-reported daytime sleepiness questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 58 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Collaborators
- Belun Technology Company Limited
- Responsible party
- Principal investigator, Goh Liang Chye, University of Malaya
- Investigators
- Varatha Raju Kugan, MD, Principal investigator, Department of Otorhinolaryngology, Head & Neck Surgery, Universiti Malaya Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785999
- Sponsor's protocol ID
- UMMC-MREC 202583-15424
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Strumpf Z, Gu W, Tsai CW, Chen PL, Yeh E, Leung L, Cheung C, Wu IC, Strohl KP, Tsai T, Folz RJ, Chiang AA. Belun Ring (Belun Sleep System BLS-100): Deep learning-facilitated wearable enables obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification in patients suspected of obstructive sleep apnea. Sleep Health. 2023 Aug;9(4):430-440. doi: 10.1016/j.sleh.2023.05.001. Epub 2023 Jun 26.
PubMed 373805906. Hasan KIB, Lim KS, Goh LC, Fong SL, Ramanaidu LP, Lee ZY, Tan CT. Sequential screenings improve prediction in obstructive sleep apnoea severity. Neurology Asia. 2025;30(2):571-585.
Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
PubMed 18431116Gottlieb DJ, Punjabi NM. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA. 2020 Apr 14;323(14):1389-1400. doi: 10.1001/jama.2020.3514.
PubMed 322866481. American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinical Upper Airway Assessment Tool With Artificial Intelligence Wearable Technology Against In-Lab Polysomnography
- ClinicalTrials.gov ID
- NCT07785999
- Acronym / sponsor ID
- UMMC-MREC 202583-15424
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, sleep parameters, polysomnography, wearable device, diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Collaborators
- Belun Technology Company Limited
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Aug 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 study evaluates whether a clinical upper airway assessment tool (the Clinical Examination Score plus ENT Examination Score, CES-EES) and an artificial-intelligence wearable ring (Belun Ring, Belun Sleep System BLS-100) can serve as accurate, less resource-intensive alternatives to in-lab polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA). Adults referred to the Otorhinolaryngology sleep clinic at Universiti Malaya Medical Centre (UMMC) for suspected OSA, who score 4 or more on the combined CES-EES scale, undergo a single overnight Level 1 in-lab PSG. The Belun Ring is worn concurrently with standard PSG electrodes during this same overnight study. The apnea-hypopnea index (AHI) from the Belun Ring and the CES-EES score, individually and in combination, are compared against the AHI from in-lab PSG -- the diagnostic reference standard -- to assess their agreement, correlation, and diagnostic accuracy for OSA.
Detailed description
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder associated with cardiovascular, cerebrovascular, and other long-term health consequences if untreated. In-lab polysomnography (PSG) is the diagnostic reference standard but is resource-intensive, costly, and associated with long waiting times. Existing screening tools such as the STOP-BANG questionnaire and the Epworth Sleepiness Scale (ESS) have recognized sensitivity/specificity trade-offs. The Clinical Examination Score (CES) combined with the ENT Examination Score (EES) is a previously described clinical scoring tool for OSA screening. The Belun Ring (Belun Sleep System BLS-100) is an FDA 510(k)-cleared (Class II), Malaysia Medical Device Authority-registered, AI/deep-learning-facilitated wearable capable of estimating AHI, sleep staging, and OSA severity.
This is a prospective, comparative, single-centre study conducted at Universiti Malaya Medical Centre (UMMC). Adults referred to the Otorhinolaryngology sleep clinic for suspected OSA, with high ESS and/or STOP-BANG scores, are screened with the CES-EES; those scoring 4 or more and otherwise meeting eligibility criteria are enrolled. After informed consent, participants undergo a standardised history, demographic data collection, and physical examination (oral cavity examination, flexible nasopharyngeal endoscopy, dental assessment), followed by a single overnight Level 1 in-lab PSG (Compumedics, 7-channel) at the UMMC Neurology Sleep Lab. The Belun Ring is fitted to the participant's index finger concurrently with standard PSG electrodes, so both devices record simultaneously during the same overnight study. A minimum of 4 hours total sleep time (TST) is required; participants with less than 4 hours TST are excluded from analysis. Both PSG and Belun Ring AHI are scored using AASM 1A criteria (hypopnea defined by desaturation of 3% or more). PSG is manually scored by a sleep technician; Belun Ring output is processed by the device's AI algorithm and independently cross-checked by two investigators.
The primary comparisons are: (1) CES-EES score against PSG AHI; (2) Belun Ring AHI against PSG AHI; and (3) CES-EES combined with Belun Ring AHI against PSG AHI. Planned statistical analyses include the paired t-test or Wilcoxon signed-rank test for comparative analysis, Bland-Altman plots for agreement/bias analysis, the intraclass correlation coefficient (ICC) for inter-scorer reliability, and descriptive statistics (mean, median, SD, range).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab P | – | Device: Belun Ring (Belun Sleep System BLS-100), Other: CES-EES Clinical ScoringAdults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab PSG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults referred to the UMMC Otorhinolaryngology sleep clinic for sleep-related breathing disorders and scheduled for in-lab PSG
Key inclusion criteria (5 listed)
- ≥18 years old
- Patients with suspected OSA (high ESS and/or STOP-BANG score)
- CES-EES score 4 or more
- Newly diagnosed cases
- Minimum 4 hours of Total Sleep Time (TST)
Key exclusion criteria (6 listed)
- Active URTI (upper respiratory tract infection) in the past 1 month
- Current smoker
- Alcohol consumption within 8 hours prior to testing
- History of head and neck carcinoma
- Active respiratory or neurological disorders
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 |
|---|---|---|
| Belun Ring (Belun Sleep System BLS-100)AI/deep-learning-facilitated wearable ring worn on the index finger concurrently with standard PSG electrodes during the overnight PSG study; estimates AHI, sleep stages, and OSA severity using AASM 1A scoring criteria (desaturation of 3% or more defines hypopnea). | Device | Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab P |
| CES-EES Clinical ScoringCombined Clinical Examination Score (CES) and ENT Examination Score (EES), administered via history, oral cavity examination, flexible nasopharyngeal endoscopy, and dental assessment prior to PSG. | Other | Adults with suspected OSA undergoing concurrent CES-EES scoring, Belun Ring monitoring, and in-lab P |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: Baseline
AHI (events/hour) derived from polysomnogram or wearable sleep study, scored using AASM 1A criteria (desaturation of 3% or more defines hypopnea); output cross-checked by two independent investigators.
2 secondary outcomes
Sleep quality parameters
Time frame: Baseline
Epworth Sleepiness Scale (ESS) score
Time frame: Baseline
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 25 Aug 2026.
- Background: PubMed 37380590Strumpf Z, Gu W, Tsai CW, Chen PL, Yeh E, Leung L, Cheung C, Wu IC, Strohl KP, Tsai T, Folz RJ, Chiang AA. Belun Ring (Belun Sleep System BLS-100): Deep learning-facilitated wearable enables obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification in patients suspected of obstructive sleep apnea. Sleep Health. 2023 Aug;9(4):430-440. doi: 10.1016/j.sleh.2023.05.001. Epub 2023 Jun 26.
- Background6. Hasan KIB, Lim KS, Goh LC, Fong SL, Ramanaidu LP, Lee ZY, Tan CT. Sequential screenings improve prediction in obstructive sleep apnoea severity. Neurology Asia. 2025;30(2):571-585.
- Background: PubMed 1798888Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Background: PubMed 18431116Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
- Background: PubMed 32286648Gottlieb DJ, Punjabi NM. Diagnosis and Management of Obstructive Sleep Apnea: A Review. JAMA. 2020 Apr 14;323(14):1389-1400. doi: 10.1001/jama.2020.3514.
- Background1. American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
- Individual participant dataSharing planned: No
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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.
Associate Professor Dr. Goh Liang Chye, MBBS contact
Varatha Raju Kugan, MD principal investigator
Department of Otorhinolaryngology, Head & Neck Surgery, Universiti Malaya Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University of Malaya at 1 site in Malaysia.
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 5 inclusion and 6 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 25 Aug 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 Malaysia. 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?
Contact Dr. Kugan a/l Varatha Raju, MD (+6012-4559957, kugan.varatha@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07785999, which also lists 6 linked publications.
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 25 Aug 2026.