NCT06454318

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 index(ODI). The main questions of this study are

  1. 1.What is the best ODI to screen for moderate to severe obstructive sleep apnea?
  2. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

April 13, 2024

Last Update Submit

June 9, 2024

Conditions

Obstructive Sleep ApneaPolysomnographyPulse Oximetry

Keywords

Obstructive Sleep ApneapolysomnographyPulse oximetryring-type pulse oximeterwearable healthcare device

Outcome Measures

Primary Outcomes (3)

  • Sensitivity

    Sensitivity of each ODI

    through study completion, an average of 1 year

  • Specificity

    Specificy of each ODI

    through study completion, an average of 1 year

  • AUC of ROC

    Area under the curve of receiver operator curve of each ODI

    through study completion, an average of 1 year

Study Arms (1)

All patients

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

Diagnostic Test: Wellue O2 ring

Interventions

Wellue O2 ringDIAGNOSTIC_TEST

Wellue O2 ring wore when doing the polysomnography

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients whom undertaking polysomnography at Sleep center of Thammasat

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep center of Thammasat

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (19)

  • 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.

    PMID: 20848319BACKGROUND

  • 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.

    PMID: 28790878BACKGROUND

  • 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.

    PMID: 16497687BACKGROUND

  • 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.

    PMID: 24673616BACKGROUND

  • 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.

    PMID: 27502205BACKGROUND

  • 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.

    PMID: 15249509BACKGROUND

  • 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.

    PMID: 17823357BACKGROUND

  • 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.

    PMID: 20625114BACKGROUND

  • 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.

    PMID: 25515104BACKGROUND

  • 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.

    PMID: 25732450BACKGROUND

  • 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.

    PMID: 10678860BACKGROUND

  • 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.

    PMID: 15781100BACKGROUND

  • 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.

    PMID: 22983957BACKGROUND

  • 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.

    PMID: 16424443BACKGROUND

  • 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.

    PMID: 20465027BACKGROUND

  • 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.

    PMID: 12047610BACKGROUND

  • 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.

    PMID: 27919588RESULT

  • 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.

    PMID: 18830731RESULT

  • 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.

    PMID: 28162150RESULT

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 13, 2024

First Posted

June 12, 2024

Study Start

February 1, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

June 12, 2024

Record last verified: 2024-06

Locations

TH(1)