Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device

June 9, 2024 updated by: James Tisyakorn, Thammasat University Hospital

The goal of this study is to find the best method to use Wellue O2 ring to screen for moderate to severe obstructive sleep apnea. The method that investigators use to screen for moderate to severe obstructive sleep apnea is oxygen desaturation index(ODI). The main questions of this study are

  1. What is the best ODI to screen for moderate to severe obstructive sleep apnea?
  2. What are the sensitivity, specificity and AUC of the study? In this study, participants are recruited from Sleep center of Thammasat prior to polysomnography. All participants in this study will

1. Undergo polysomnography according to Sleep center of Thammasat protocol 2. Wear Wellue O2 ring when undertaking polysomnography If the polysomnography is switch to PAP titration Wellue O2 ring will be taken out.

Data of Oxygen data from Wellue O2 ring are collected and compared with AHI. Investigators will find the best ODI to screen for obstructive sleep apnea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

  • Obstructive sleep apnea is a highly prevalent sleep-related disease.
  • Moderate to severe obstructive sleep apnea is linked with traffic accident and other medical condition such as hypertension, pulmonary hypertension, myocardial infarction, stroke and diabetes mellitus
  • Screening for obstructive sleep apnea using questionaires such as STOP-BANG and ESS (Epworth sleepiness scale) provide good sensitivity but low specificity
  • Polysomnography used to diagnosed obstructive sleep apnea has limited assessibility and prolonged waiting time.
  • Overnight pulse oximetry had been used to screen for obstructive sleep apnea and provided good sensitivity and specificity for screening obstructive sleep apnea using ODI (Oxygen desaturation index)
  • Wellue O2 ring, a commercial grade pulse oximeter, with a frequency of measuring oxygen saturation of 0.25 Hz (compare to overnight pulse oximetry of 1 Hz) can measured oxygen saturation overnight with lower cost than overnight pulse oximetry (medical grade device)
  • In this study, investigators want to find the best ODI to use to screen for moderate to severe obstructive sleep apnea. Investigators will find the sensitivity specificity and AUC of ROC curver in each ODI.

Outcome

  • Sensitivity, Specificiy and area under the curve of ROC curve of each ODI. Sample size calculation
  • Referencing previous studies (Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017;13(3):479-504. Published 2017 Mar 15. doi:10.5664/jcsm.6506) The sensitivity of single channel home sleep test is 73% using Z = 1.96 and prevalence of 0.64 and d = 0.1 investigators get a population of 118 people. Investigators collected 42 more people in case of total sleep time < 2 hours.

Recruitment

  • Patients are recruited prior to undertaking polysomnography test Eligibility criteria Inclusion criteria
  • Patients age ≥ 18 years old Exclusion criteria
  • Patients with pacemaker or intra-cardiac defibrillator
  • Patients with suspected periodic limb movement disorder, insomnia, parasomnia, nacrolepsy and obesity hypoventilation syndrome
  • Patients who canot wear O2 ring
  • Patients with congestive heart failure, COPD, Asthma or Neuromuscular disorder
  • Patients with desaturation when awake
  • Patient with Scleroderma and Raynaud phenomenon

Study procedures

  • After inform consent was obtained age, gender, body weight, height, neck circumference,underlying disease, STOP-BANG and ESS score are recorded
  • Patients wear Wellue O2 ring when undergoing polysomnography, oxygen data were recorded from wellue O2 ring
  • Data of AHI is extracted from the polysomnography report
  • Data from wellue O2 ring is exported from wellu2 O2 ring using bluetooth in .csv format.
  • Investigators excluded patient with Total sleep time < 2 hrs
  • Baseline characteristic, oxygen saturation data and AHI are inputed in STATA version 17
  • Investigators find the multiple ODI criteria and find the best ODI with the best sensitivity and specificity and AUC of ROC for screening moderate to severe obstructive sleep apnea.

Study Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathum Thani
      • Khlong Luang, Pathum Thani, Thailand, 12120
        • Sleep center of Thammasat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients whom undertaking polysomnography at Sleep center of Thammasat

Description

Inclusion Criteria:

  • Age >= 18 years old
  • Undertaking polysomnography at Sleep center of Thammasat

Exclusion Criteria:

  • Patient with pacemaker or intra-cardiac defibrillator
  • Patient suspected to have periodic limb movement disorder, insomnia, parasomnia, narcolepsy, obesity hypoventilation syndrome
  • Patient who cannot wear Wellue O2 ring
  • Patient suspected to have congestive heart failure, COPD, neuromuscular disorder
  • Patient who have baseline O2 saturation below 92%
  • Patient who have scleroderma or having Raynaud phenomenon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
Patients undergoing polysomnography and having Wellue O2 ring wear when doing polysomnography
Diagnostic test: Wellue O2 ring
Wellue O2 ring wore when doing the polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: through study completion, an average of 1 year
Sensitivity of each ODI
through study completion, an average of 1 year
Specificity
Time Frame: through study completion, an average of 1 year
Specificy of each ODI
through study completion, an average of 1 year
AUC of ROC
Time Frame: through study completion, an average of 1 year
Area under the curve of receiver operator curve of each ODI
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

April 13, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-IM-1-066/65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obstructive Sleep Apnea

Clinical Trials on Wellue O2 ring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe