Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454318
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-04-13
Brief Title:
Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device
Sponsor:
Thammasat University Hospital
Organization:
Thammasat University Hospital
Study Overview
Official Title:
Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 indexODI 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
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
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 025 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 2017133479-504 Published 2017 Mar 15 doi105664jcsm6506 The sensitivity of single channel home sleep test is 73 using Z 196 and prevalence of 064 and d 01 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 circumferenceunderlying 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
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 025 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 2017133479-504 Published 2017 Mar 15 doi105664jcsm6506 The sensitivity of single channel home sleep test is 73 using Z 196 and prevalence of 064 and d 01 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 circumferenceunderlying 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None