Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study

Sleep-Disordered Breathing Clinical Trial

— ROSA  

Official title:

Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06221124
• Other study ID #: SPO#179613
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: June 12, 2023

Study information

• Verified date: January 2024
• Source: Belun Technology Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 12, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Architecture
• Sleep-Disordered Breathing

Intervention

Device:
• Belun Ring Pulse Oximeter
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.

Locations

Country	Name	City	State
United States	Stanford Sleep Medecine Center	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Belun Technology Company Limited	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation with gold-standard polysomnography (PSG) recording	Concordance rate of bAHI from Belun Ring and apnea-hypopnea Index (AHI) from PSG	1 year