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CompletedNCT06454318Updated Jun 12, 2024

Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device

An observational study in Obstructive Sleep Apnea, Polysomnography and Pulse Oximetry, sponsored by Thammasat University Hospital. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-12.

Sponsored by Thammasat University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
192
Ages
18 Years and older
Sex
All
01

Study 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 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.

Read the 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.
02

Conditions studied

  • Obstructive Sleep Apnea
  • Polysomnography
  • Pulse Oximetry

Keywords

  • Obstructive Sleep Apnea
  • polysomnography
  • Pulse oximetry
  • ring-type pulse oximeter
  • wearable healthcare device
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 192 is above the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Thammasat University Hospital is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients whom undertaking polysomnography at Sleep center of Thammasat

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
192 participants (actual)
Patient registry
No

Groups and cohorts

  • All patients

    Patients undergoing polysomnography and having Wellue O2 ring wear when doing polysomnography

    Diagnostic Test: Wellue O2 ring

Interventions

  • Diagnostic testWellue O2 ring

    Wellue O2 ring wore when doing the polysomnography

06

What researchers measure

Primary outcomes

  1. Sensitivity

    Sensitivity of each ODI

    Time frame: through study completion, an average of 1 year

  2. Specificity

    Specificy of each ODI

    Time frame: through study completion, an average of 1 year

  3. AUC of ROC

    Area under the curve of receiver operator curve of each ODI

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Sleep center of Thammasat
    Khlong Luang, Pathum Thani 12120, Thailand
08

References and documents

Publications

  • Neruntarat C, Chantapant S. Prevalence of sleep apnea in HRH Princess Maha Chakri Srinthorn Medical Center, Thailand. Sleep Breath. 2011 Dec;15(4):641-8. doi: 10.1007/s11325-010-0412-x. Epub 2010 Sep 17. PubMed 20848319 ↗
  • Stewart SA, Penz E, Fenton M, Skomro R. Investigating Cost Implications of Incorporating Level III At-Home Testing into a Polysomnography Based Sleep Medicine Program Using Administrative Data. Can Respir J. 2017;2017:8939461. doi: 10.1155/2017/8939461. Epub 2017 Jul 16. PubMed 28790878 ↗
  • Arias MA, Garcia-Rio F, Alonso-Fernandez A, Martinez I, Villamor J. Pulmonary hypertension in obstructive sleep apnoea: effects of continuous positive airway pressure: a randomized, controlled cross-over study. Eur Heart J. 2006 May;27(9):1106-13. doi: 10.1093/eurheartj/ehi807. Epub 2006 Feb 23. PubMed 16497687 ↗
  • Campos-Rodriguez F, Martinez-Garcia MA, Reyes-Nunez N, Caballero-Martinez I, Catalan-Serra P, Almeida-Gonzalez CV. Role of sleep apnea and continuous positive airway pressure therapy in the incidence of stroke or coronary heart disease in women. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1544-50. doi: 10.1164/rccm.201311-2012OC. PubMed 24673616 ↗
  • Fu Y, Xia Y, Yi H, Xu H, Guan J, Yin S. Meta-analysis of all-cause and cardiovascular mortality in obstructive sleep apnea with or without continuous positive airway pressure treatment. Sleep Breath. 2017 Mar;21(1):181-189. doi: 10.1007/s11325-016-1393-1. Epub 2016 Aug 8. PubMed 27502205 ↗
  • Gami AS, Pressman G, Caples SM, Kanagala R, Gard JJ, Davison DE, Malouf JF, Ammash NM, Friedman PA, Somers VK. Association of atrial fibrillation and obstructive sleep apnea. Circulation. 2004 Jul 27;110(4):364-7. doi: 10.1161/01.CIR.0000136587.68725.8E. Epub 2004 Jul 12. PubMed 15249509 ↗
  • George CF. Sleep apnea, alertness, and motor vehicle crashes. Am J Respir Crit Care Med. 2007 Nov 15;176(10):954-6. doi: 10.1164/rccm.200605-629PP. Epub 2007 Sep 6. PubMed 17823357 ↗
  • Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12. PubMed 20625114 ↗
  • Hla KM, Young T, Hagen EW, Stein JH, Finn LA, Nieto FJ, Peppard PE. Coronary heart disease incidence in sleep disordered breathing: the Wisconsin Sleep Cohort Study. Sleep. 2015 May 1;38(5):677-84. doi: 10.5665/sleep.4654. PubMed 25515104 ↗
  • Ismail K, Roberts K, Manning P, Manley C, Hill NS. OSA and pulmonary hypertension: time for a new look. Chest. 2015 Mar;147(3):847-861. doi: 10.1378/chest.14-0614. PubMed 25732450 ↗
  • Lavie P, Herer P, Hoffstein V. Obstructive sleep apnoea syndrome as a risk factor for hypertension: population study. BMJ. 2000 Feb 19;320(7233):479-82. doi: 10.1136/bmj.320.7233.479. PubMed 10678860 ↗
  • Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7. PubMed 15781100 ↗
  • Martinez-Garcia MA, Campos-Rodriguez F, Catalan-Serra P, Soler-Cataluna JJ, Almeida-Gonzalez C, De la Cruz Moron I, Duran-Cantolla J, Montserrat JM. Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long-term continuous positive airway pressure treatment: a prospective observational study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):909-16. doi: 10.1164/rccm.201203-0448OC. Epub 2012 Sep 13. PubMed 22983957 ↗
  • Mehra R, Benjamin EJ, Shahar E, Gottlieb DJ, Nawabit R, Kirchner HL, Sahadevan J, Redline S; Sleep Heart Health Study. Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study. Am J Respir Crit Care Med. 2006 Apr 15;173(8):910-6. doi: 10.1164/rccm.200509-1442OC. Epub 2006 Jan 19. PubMed 16424443 ↗
  • Tregear S, Reston J, Schoelles K, Phillips B. Obstructive sleep apnea and risk of motor vehicle crash: systematic review and meta-analysis. J Clin Sleep Med. 2009 Dec 15;5(6):573-81. PubMed 20465027 ↗
  • Yamakawa H, Shiomi T, Sasanabe R, Hasegawa R, Ootake K, Banno K, Wakayama H, Katada M, Kobayashi T. Pulmonary hypertension in patients with severe obstructive sleep apnea. Psychiatry Clin Neurosci. 2002 Jun;56(3):311-2. doi: 10.1046/j.1440-1819.2002.00957.x. PubMed 12047610 ↗
  • Chiu HY, Chen PY, Chuang LP, Chen NH, Tu YK, Hsieh YJ, Wang YC, Guilleminault C. Diagnostic accuracy of the Berlin questionnaire, STOP-BANG, STOP, and Epworth sleepiness scale in detecting obstructive sleep apnea: A bivariate meta-analysis. Sleep Med Rev. 2017 Dec;36:57-70. doi: 10.1016/j.smrv.2016.10.004. Epub 2016 Nov 5. PubMed 27919588 ↗
  • Nigro CA, Aimaretti S, Gonzalez S, Rhodius E. Validation of the WristOx 3100 oximeter for the diagnosis of sleep apnea/hypopnea syndrome. Sleep Breath. 2009 May;13(2):127-36. doi: 10.1007/s11325-008-0217-3. Epub 2008 Oct 2. PubMed 18830731 ↗
  • Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. 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 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506. PubMed 28162150 ↗

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06454318
Lead sponsor
Thammasat University Hospital
Responsible party
James Tisyakorn (Doctor, Thammasat University Hospital) — Principal investigator
First posted
Jun 12, 2024
Start date
Feb 1, 2023
Primary completion
Jan 31, 2024
Completion
Jan 31, 2024
Last update
Jun 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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