Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device

Obstructive Sleep Apnea Clinical Trial

Official title:

Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06454318
• Other study ID #: MTU-EC-IM-1-066/65
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: June 2024
• Source: Thammasat University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Polysomnography
• Pulse Oximetry
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Wellue O2 ring
Wellue O2 ring wore when doing the polysomnography

Locations

Country	Name	City	State
Thailand	Sleep center of Thammasat	Khlong Luang	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Ma — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity of each ODI	through study completion, an average of 1 year
Primary	Specificity	Specificy of each ODI	through study completion, an average of 1 year
Primary	AUC of ROC	Area under the curve of receiver operator curve of each ODI	through study completion, an average of 1 year

External Links

•   Association of atrial fibrillation and obstructive sleep apnea
•   Association of nocturnal arrhythmias with sleep-disordered breathing: The Sleep Heart Health Study
•   Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long-term continuous positive airway pressure treatment: a prospective observational study
•   Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline
•   Coronary heart disease incidence in sleep disordered breathing: the Wisconsin Sleep Cohort Study
•   Diagnostic accuracy of the Berlin questionnaire, STOP-BANG, STOP, and Epworth sleepiness scale in detecting obstructive sleep apnea: A bivariate meta-analysis
•   Investigating Cost Implications of Incorporating Level III At-Home Testing into a Polysomnography Based Sleep Medicine Program Using Administrative Data
•   Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study
•   Meta-analysis of all-cause and cardiovascular mortality in obstructive sleep apnea with or without continuous positive airway pressure treatment
•   Obstructive sleep apnoea syndrome as a risk factor for hypertension: population study
•   OSA and pulmonary hypertension: time for a new look
•   Prevalence of sleep apnea in HRH Princess Maha Chakri Srinthorn Medical Center, Thailand
•   Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study
•   Pulmonary hypertension in obstructive sleep apnoea: effects of continuous positive airway pressure: a randomized, controlled cross-over study
•   Pulmonary hypertension in patients with severe obstructive sleep apnea
•   Role of sleep apnea and continuous positive airway pressure therapy in the incidence of stroke or coronary heart disease in women
•   Sleep apnea, alertness, and motor vehicle crashes
•   Validation of the WristOx 3100 oximeter for the diagnosis of sleep apnea/hypopnea syndrome