Pulse Oximeter for Sleep Evaluation

Study Overview
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Brief Summary
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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.

Official Title
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Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study (ROSA Study)

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Diagnostic Test: Belun Ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Possible OSA<br>Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.) | Diagnostic Test: Belun Ring<br>* Simultaneous recording of Belun Ring data (pulse oximeter, pulse rate and actigraphy) and standard of care PSG will be performed for one night.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation with gold-standard polysomnography (PSG) recording | Concordance rate of respiratory disturbance index (RDI) from Belun Ring and apnea-hypopnea Index (AHI) from PSG | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, pulse oximeter, polysomnography