Sleep-Disordered BreathingROSANCT06221124
Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study
A study testing Belun Ring Pulse Oximeter in people with Sleep-Disordered Breathing and Sleep Architecture, run by Belun Technology Company Limited at 1 site in United States.
Trial summary
Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment method. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep-Disordered Breathing, Sleep Architecture
- What is being tested?
- Belun Ring Pulse Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 12 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 80 years old. Ideally balanced for sex and age (18 to 80 years old)
- no more than 75% of subjects in one bin of: (male, female)
- no more than 50% of subjects in one age-group (18-29, 30-39, 40-49, 50-59, 60-80)
- Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)
- Without any unstable medical or psychiatric co-morbidities that would be expected to interfere with the study.
- If taking any medication, must be on a stable dose of medication for a month
- Able to read and understand English
Who cannot join
- Presence of any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol, suicidality, current regular use of psychiatric medications, opiates, or thyroid medications, dementia, current substance abuse, post-traumatic or psychotic disorders, bipolar disorder; any significant neurologic disease, including possible and probable dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma, history of alcohol or substance use disorder within the past 2 years (DSM V criteria);
- If positive airway pressure (PAP) titration study or split night study (diagnostic and PAP titration study combined)
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Sleep Medecine Center
Redwood City, California, 94063
About this study
Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment method. Thus, combining ELAM with PSG will validate ELAM and improve its clinical and research utilization.
The investigators propose to conduct this study to validate ELAM device for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab PSG measures of Sleep-Disordered Breathing (SDB) and sleep architecture in adults with obstructive sleep apnea (OSA) symptoms.
The investigators propose to recruit a total of 40 participants with symptoms of OSA. The overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture will be validated by using PSG analysis as a gold standard.
- Conditions
- Sleep-Disordered Breathing, Sleep Architecture
- Being tested
- Belun Ring Pulse Oximeter
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belun Ring Pulse OximeterDevice
Belun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Sleep stage (bSTAGES) and respiratory event index (bAHI) are estimated.
| Study group | Role | What they receive |
|---|---|---|
| BEL-Participant | Experimental | First, we will measure the size of the finger of the participant and select appropriate size of Belun Ring device and the participant will be instructed to wear it on a finger in addition to regular PSG set up on the night of sleep study. Simultaneous recording of Belun Ring data {pulse oximeter, pulse rate and actigraphy} and standard PSG will be performed for one night. Receives: Device: Belun Ring Pulse Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation with gold-standard polysomnography (PSG) recording
Concordance rate of bAHI from Belun Ring and apnea-hypopnea Index (AHI) from PSG
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start15 Jul 2020
- Primary completion1 Dec 2021
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belun Technology Company Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221124
- Sponsor's protocol ID
- SPO#179613
- Acronym
- ROSA
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study
- ClinicalTrials.gov ID
- NCT06221124
- Acronym / sponsor ID
- ROSA / SPO#179613
- Conditions
- Sleep-Disordered Breathing, Sleep Architecture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Belun Technology Company LimitedUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 24 Jan 2024 (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.
Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment method. Thus, combining ELAM with PSG will validate ELAM and improve its clinical and research utilization.
The investigators propose to conduct this study to validate ELAM device for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab PSG measures of Sleep-Disordered Breathing (SDB) and sleep architecture in adults with obstructive sleep apnea (OSA) symptoms.
The investigators propose to recruit a total of 40 participants with symptoms of OSA. The overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture will be validated by using PSG analysis as a gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEL-Participant | Experimental | Device: Belun Ring Pulse OximeterFirst, we will measure the size of the finger of the participant and select appropriate size of Belun Ring device and the participant will be instructed to wear it on a finger in addition to regular PSG set up on the night of sleep study. Simultaneous recording of Belun Ring data {pulse oximeter, pulse rate and actigraphy} and standard PSG will be performed for one night. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 to 80 years old. Ideally balanced for sex and age (18 to 80 years old)
- no more than 75% of subjects in one bin of: (male, female)
- no more than 50% of subjects in one age-group (18-29, 30-39, 40-49, 50-59, 60-80)
- Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)
- Without any unstable medical or psychiatric co-morbidities that would be expected to interfere with the study.
Key exclusion criteria (2 listed)
- Presence of any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol, suicidality, current regular use of psychiatric medications, opiates, or thyroid medications, dementia, current substance abuse, post-traumatic or psychotic disorders, bipolar disorder; any significant neurologic disease, including possible and probable dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma, history of alcohol or substance use disorder within the past 2 years (DSM V criteria);
- If positive airway pressure (PAP) titration study or split night study (diagnostic and PAP titration study combined)
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 Pulse OximeterBelun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Sleep stage (bSTAGES) and respiratory event index (bAHI) are estimated. | Device | BEL-Participant |
Primary outcome
Validation with gold-standard polysomnography (PSG) recording
Time frame: 1 year
Concordance rate of bAHI from Belun Ring and apnea-hypopnea Index (AHI) from PSG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belun Ring Pulse Oximeter in people with Sleep-Disordered Breathing and Sleep Architecture, run by Belun Technology Company Limited at 1 site in United States.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jan 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation with gold-standard polysomnography (PSG) recording (time frame: 1 year). 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 24 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.