Obstructive Sleep ApneaROSANCT04612114
Pulse Oximeter for Sleep Evaluation
An observational study of Obstructive Sleep Apnea, run by Stanford University at 1 site in United States.
Trial summary
The investigators will conduct this study to validate Belun Ring for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab polysomnography (PSG) measures of SDB and sleep architecture in adults with OSA symptoms. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Belun Ring
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 30 Apr 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: i) 40 participants ii) All enrollment will be at Stanford iii) Patients with obstructive sleep apnea will be enrolled
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)
- Under 18 or over 80 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study (ROSA Study)
The investigators will conduct this study to validate Belun Ring for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab polysomnography (PSG) measures of SDB and sleep architecture in adults with OSA symptoms.
The investigators propose to recruit a total of 40 participants with symptoms of obstructive sleep apnea. The investigators will i) validate the overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture, using PSG analysis as a gold standard.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Belun Ring
- Keywords
- obstructive sleep apnea, pulse oximeter, polysomnography
- 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 RingDiagnostic test
Simultaneous recording of Belun Ring data (pulse oximeter, pulse rate and actigraphy) and standard of care PSG will be performed for one night.
| Study group | Role | What they receive |
|---|---|---|
| Possible OSA | Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.) Receives: Diagnostic Test: Belun Ring |
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 respiratory disturbance index (RDI) from Belun Ring and apnea-hypopnea Index (AHI) from PSG
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start21 Jul 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Belun Technology Company Limited
- Responsible party
- Principal investigator, Makoto Kawai, Stanford University
- Investigators
- Makoto Kawai, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612114
- Sponsor's protocol ID
- 53979
- Acronym
- ROSA
- Status last verified
- Jun 2022
- First submitted
- 22 Oct 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 22 Jun 2022. 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 (ROSA Study)
- ClinicalTrials.gov ID
- NCT04612114
- Acronym / sponsor ID
- ROSA / 53979
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, pulse oximeter, polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Belun Technology Company Limited
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 2 Nov 2020 (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.
The investigators will conduct this study to validate Belun Ring for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab polysomnography (PSG) measures of SDB and sleep architecture in adults with OSA symptoms.
The investigators propose to recruit a total of 40 participants with symptoms of obstructive sleep apnea. The investigators will i) validate the overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture, using PSG analysis as a gold standard.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Possible OSA | – | Diagnostic Test: Belun RingPatients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- i) 40 participants ii) All enrollment will be at Stanford iii) Patients with obstructive sleep apnea will be enrolled
Key inclusion criteria (7 listed)
- Age between 18 to 80 years old. Ideally balanced for sex and age (18 to 80 years old)
- 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
Key exclusion criteria (3 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)
- Under 18 or over 80 years of age
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 RingSimultaneous recording of Belun Ring data (pulse oximeter, pulse rate and actigraphy) and standard of care PSG will be performed for one night. | Diagnostic test | Possible OSA |
Primary outcome
Validation with gold-standard polysomnography (PSG) recording
Time frame: through study completion, an average of 1 year
Concordance rate of respiratory disturbance index (RDI) 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 22 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
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.
Makoto Kawai, MD principal investigator
Stanford University
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 Stanford University 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 3 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 22 Jun 2022. 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: through study completion, an average of 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 22 Jun 2022.