Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea, pulse oximeter, polysomnography
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.
Interventions
DIAGNOSTIC_TESTBelun Ring
Simultaneous recording of Belun Ring data (pulse oximeter, pulse rate and actigraphy) and standard of care PSG will be performed for one night.
Sponsors
Belun Technology Company Limited
Stanford University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
1. 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) 2. Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.) 3. Without any unstable medical or psychiatric co-morbidities that would be expected to interfere with the study. 4. If taking any medication, must be on a stable dose of medication for a month 5. Able to read and understand English
Exclusion criteria
1. 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); 2. If positive airway pressure (PAP) titration study or split night study (diagnostic and PAP titration study combined) 3. Under 18 or over 80 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation with gold-standard polysomnography (PSG) recording | 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 |
Countries
United States
Outcome results
None listed