Pulse Oximeter for Sleep Evaluation | NCT04612114

Studies
Pulse Oximeter for Sleep Evaluation

NCT04612114

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jun 22, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

Belun Ring

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2020Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Oct 22, 2020

First Submission Date that Met QC Criteria

Oct 27, 2020

First Posted Date

Nov 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2022

Last Update Posted Date

Jun 22, 2022Actual

Name	Class
Belun Technology Company Limited	OTHER

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Possible OSA		Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)	Diagnostic Test: Belun Ring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Belun Ring	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.	Possible OSA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)
Under 18 or over 80 years of age

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

i) 40 participants ii) All enrollment will be at Stanford iii) Patients with obstructive sleep apnea will be enrolled

Sampling Method

Non-Probability Sample

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases