Pulse Oximeter for Sleep Evaluation

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Diagnostic Test: Belun Ring

• Registration Number: NCT04612114
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-21
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Possible OSA	Belun Ring	Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)

Primary Outcome Measures

Name	Time	Method
Validation with gold-standard polysomnography (PSG) recording	through study completion, an average of 1 year	Concordance rate of respiratory disturbance index (RDI) from Belun Ring and apnea-hypopnea Index (AHI) from PSG

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Redwood City, California, United States