Pulse Oximeter for Sleep Evaluation

Obstructive Sleep Apnea Clinical Trial

— ROSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612114
• Other study ID #: 53979
• Status: Completed
• Start date: July 21, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Redwood City	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Belun Technology Company Limited

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 respiratory disturbance index (RDI) from Belun Ring and apnea-hypopnea Index (AHI) from PSG	through study completion, an average of 1 year