Pulse Oximeter for Sleep Evaluation (ROSA)

Stanford University

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Diagnostic Test: Belun Ring

Study type: Observational

Funder types: Other

Identifiers

NCT04612114

53979

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Possible OSA

Description:

Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)

Treatment:

Diagnostic Test: Belun Ring