Obstructive Sleep ApneaNCT06454318
Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device
An observational study of Obstructive Sleep Apnea and Polysomnography, run by Thammasat University Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Polysomnography, Pulse Oximetry
- What is being tested?
- Wellue O2 ring
- How many people
- 192 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients whom undertaking polysomnography at Sleep center of Thammasat
Who may be able to join
- Age >= 18 years old
- Undertaking polysomnography at Sleep center of Thammasat
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Sleep center of Thammasat
Khlong Luang, Changwat Pathum Thani, 12120
About this study
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
- What is the best ODI to screen for moderate to severe obstructive sleep apnea?
- 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
- 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.
- Conditions
- Obstructive Sleep Apnea, Polysomnography, Pulse Oximetry
- Being tested
- Wellue O2 ring
- Keywords
- Obstructive Sleep Apnea, polysomnography, Pulse oximetry, ring-type pulse oximeter, wearable healthcare device
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellue O2 ringDiagnostic test
Wellue O2 ring wore when doing the polysomnography
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patients undergoing polysomnography and having Wellue O2 ring wear when doing polysomnography Receives: Diagnostic Test: Wellue O2 ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of each ODI
Measured: through study completion, an average of 1 year
Specificity
Specificy of each ODI
Measured: through study completion, an average of 1 year
AUC of ROC
Area under the curve of receiver operator curve of each ODI
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Feb 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Tisyakorn, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454318
- Sponsor's protocol ID
- MTU-EC-IM-1-066/65
- Status last verified
- Jun 2024
- First submitted
- 13 Apr 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 20848319Stewart 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 28790878Arias 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 16497687Campos-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 24673616Fu 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 27502205Gami 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 15249509George 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 17823357Gottlieb 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 20625114Hla 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 25515104Ismail 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 25732450Lavie 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 10678860Marin 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 15781100Martinez-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 22983957Mehra 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 16424443Tregear 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Moderate to Severe Obstructive Sleep Apnea With Wearable Device
- ClinicalTrials.gov ID
- NCT06454318
- Acronym / sponsor ID
- MTU-EC-IM-1-066/65
- Conditions
- Obstructive Sleep Apnea, Polysomnography, Pulse Oximetry
- Keywords
- Obstructive Sleep Apnea, polysomnography, Pulse oximetry, ring-type pulse oximeter, wearable healthcare device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Thammasat University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- What is the best ODI to screen for moderate to severe obstructive sleep apnea?
- 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
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Diagnostic Test: Wellue O2 ringPatients undergoing polysomnography and having Wellue O2 ring wear when doing polysomnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whom undertaking polysomnography at Sleep center of Thammasat
Key inclusion criteria (2 listed)
- Age >= 18 years old
- Undertaking polysomnography at Sleep center of Thammasat
Key exclusion criteria (6 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellue O2 ringWellue O2 ring wore when doing the polysomnography | Diagnostic test | All patients |
Primary outcome
Sensitivity
Time frame: through study completion, an average of 1 year
Sensitivity of each ODI
Specificity
Time frame: through study completion, an average of 1 year
Specificy of each ODI
AUC of ROC
Time frame: through study completion, an average of 1 year
Area under the curve of receiver operator curve of each ODI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Background: PubMed 20848319Neruntarat 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.
- Background: PubMed 28790878Stewart 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.
- Background: PubMed 16497687Arias 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.
- Background: PubMed 24673616Campos-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.
- Background: PubMed 27502205Fu 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.
- Background: PubMed 15249509Gami 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.
- Background: PubMed 17823357George 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.
- Background: PubMed 20625114Gottlieb 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.
- Background: PubMed 25515104Hla 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.
- Background: PubMed 25732450Ismail 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.
- Background: PubMed 10678860Lavie 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.
- Background: PubMed 15781100Marin 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.
- Prevalence of sleep apnea in HRH Princess Maha Chakri Srinthorn Medical Center, ThailandLink provided by the sponsor.
- Investigating Cost Implications of Incorporating Level III At-Home Testing into a Polysomnography Based Sleep Medicine Program Using Administrative DataLink provided by the sponsor.
- Pulmonary hypertension in obstructive sleep apnoea: effects of continuous positive airway pressure: a randomized, controlled cross-over studyLink provided by the sponsor.
- Role of sleep apnea and continuous positive airway pressure therapy in the incidence of stroke or coronary heart disease in womenLink provided by the sponsor.
- Meta-analysis of all-cause and cardiovascular mortality in obstructive sleep apnea with or without continuous positive airway pressure treatmentLink provided by the sponsor.
- Association of atrial fibrillation and obstructive sleep apneaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Polysomnography, run by Thammasat University Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454318, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.