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OpenTrials
Completed

NCT Number: NCT06221124

Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study

Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment method. Thus, combining ELAM with PSG will validate ELAM and improve its clinical and research utilization.

The investigators propose to conduct this study to validate ELAM device for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab PSG measures of Sleep-Disordered Breathing (SDB) and sleep architecture in adults with obstructive sleep apnea (OSA) symptoms.

The investigators propose to recruit a total of 40 participants with symptoms of OSA. The overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture will be validated by 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

Interventional

Phase

Not applicable

Primary location

Stanford Sleep Medecine Center

Redwood City, California, 94063, United States

Who can participate

Healthy volunteers accepted: No

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)

Treatment and study plan

Belun Ring Pulse Oximeter

Device

Belun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Sleep stage (bSTAGES) and respiratory event index (bAHI) are estimated.

Primary outcomes

  1. Validation with gold-standard polysomnography (PSG) recording

    Time frame: 1 year

    Concordance rate of bAHI from Belun Ring and apnea-hypopnea Index (AHI) from PSG

Sponsors and collaborators

Lead sponsor

Belun Technology Company Limited

Other

Collaborators

  • Stanford University

Registry information

Acronym: ROSA

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Jan 24, 2024
Registry last updated
Jan 24, 2024

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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