Pulse Oximeter for Sleep Evaluation

NCT04612114 | Completed FDA Device

• 1 other identifier: 53979
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; pulse oximeter; polysomnography

Outcome Measures

Primary Outcomes (1)

• Validation with gold-standard polysomnography (PSG) recording

  Concordance rate of respiratory disturbance index (RDI) from Belun Ring and apnea-hypopnea Index (AHI) from PSG

  through study completion, an average of 1 year

Study Arms (1)

Possible OSA

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

Diagnostic Test: Belun Ring

Interventions

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.

Possible OSA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

i) 40 participants ii) All enrollment will be at Stanford iii) Patients with obstructive sleep apnea will be enrolled

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Belun Technology Company Limited: collaborator

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Makoto Kawai, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 2, 2020
• Study Start: July 21, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)