Pulse Oximeter for Sleep Evaluation

NCT ID: NCT04612114

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-21
• Study Completion Date: 2022-04-30

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Possible OSA

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

Belun Ring

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belun Technology Company Limited

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Makoto Kawai

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Makoto Kawai, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Redwood City, California, United States

Countries

United States

Other Identifiers

53979

Identifier Type: -

Identifier Source: org_study_id