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OpenTrials
Completed

NCT Number: NCT04612114

Pulse Oximeter for Sleep Evaluation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Redwood City, California, 94063, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Belun Ring

Diagnostic Test

Simultaneous recording of Belun Ring data (pulse oximeter, pulse rate and actigraphy) and standard of care PSG will be performed for one night.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Belun Technology Company Limited

Registry information

Official study title

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

Acronym: ROSA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2020
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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