Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study (ROSA Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- Stanford University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Validation with gold-standard polysomnography (PSG) recording
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
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.
Investigators
Makoto Kawai
Clinical Associate Professor
Stanford University
Eligibility Criteria
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
Outcomes
Primary Outcomes
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