Pulse Oximeter for Sleep Evaluation (ROSA)

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: Belun Ring

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Possible OSA; Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)	Diagnostic test: Belun Ring; Simultaneous recording of Belun Ring data (pulse oximeter, pulse rate and actigraphy) and standard of care PSG will be performed for one night.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Belun Technology Company Limited
• Investigators: Principal Investigator: Makoto Kawai, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2020
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): April 30, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (ACTUAL): November 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: polysomnography; obstructive sleep apnea; pulse oximeter
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 53979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No