- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07376343
Comparative Study of CPAP Predictive Equations and In-laboratory Manual Titration in Thai Patients With Obstructive Sleep Apnea
The goal of this observational study is to compare predictive equations for continuous positive airway pressure (CPAP) with in-laboratory manual titration in patients with obstructive sleep apnea (OSA).
The main question the study aims to answer is:
Which CPAP predictive equation best predicts the optimal CPAP pressure in OSA patients in Thailand? Participants will undergo an in-laboratory sleep study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Narongkorn Saiphoklang, MD
- Phone Number: +6629269794
- Email: M_narongkorn@hotmail.com
Study Contact Backup
- Name: Apiwat Pugongchai, MSc
- Phone Number: +669269142
- Email: pu.apiwat@gmail.com
Study Locations
-
-
-
Pathum Thani, Thailand, 12120
- Recruiting
- Faculty of Medicine, Thammasat University
-
Contact:
- Narongkorn Saiphoklang, MD
- Phone Number: +6629269794
- Email: M_narongkorn@hotmail.com
-
Contact:
- Apiwat Pugongchai, MSc
- Phone Number: +6629269142
- Email: pu.apiwat@gmail.com
-
Pathum Thani, Thailand, 12120
- Recruiting
- Narongkorn Saiphoklang
-
Contact:
- Narongkorn Saiphoklang, MD
- Phone Number: +6629269794
- Email: M_narongkorn@hotmail.com
-
Principal Investigator:
- Narongkorn Saiphoklang, MD
-
Contact:
- Apiwat Pugongchai, MSc
- Phone Number: +6629269142
- Email: pu.apiwat@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Suspected OSA
- Undergoing an in-laboratory sleep study
Exclusion Criteria:
- No indication for in-laboratory manual CPAP titration
- Failure to determine an optimal CPAP pressure during in-laboratory manual CPAP titration
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Obstructive sleep apnea (OSA)
Patients aged 18 years or older with OSA
|
Type 1 polysomnography will be performed in the Sleep Center of Thammasat (SCENT).
CPAP predictive equations will be selected based on evidence from reliable studies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of CPAP equations in predicting the optimal pressure in OSA patients
Time Frame: At baseline
|
Sensitivity and specificity (%) of CPAP equations in predicting the optimal pressure in OSA patients
|
At baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Narongkorn Saiphoklang, Thammasat University Faculty of Medicine
Publications and helpful links
General Publications
- Lin IF, Chuang ML, Liao YF, Chen NH, Li HY. Predicting effective continuous positive airway pressure in Taiwanese patients with obstructive sleep apnea syndrome. J Formos Med Assoc. 2003 Apr;102(4):215-21.
- Chuang ML, Lin IF, Vintch JR, Liao YF. Predicting continuous positive airway pressure from a modified split-night protocol in moderate to severe obstructive sleep apnea-hypopnea syndrome. Intern Med. 2008;47(18):1585-92. doi: 10.2169/internalmedicine.47.1107. Epub 2008 Sep 16.
- Luo J, Xiao S, Qiu Z, Song N, Luo Y. Comparison of manual versus automatic continuous positive airway pressure titration and the development of a predictive equation for therapeutic continuous positive airway pressure in Chinese patients with obstructive sleep apnoea. Respirology. 2013 Apr;18(3):528-33. doi: 10.1111/resp.12014.
- Wu MF, Hsu JY, Huang WC, Shen GH, Wang JM, Wen CY, Chang KM. Should sleep laboratories have their own predictive formulas for continuous positive airway pressure for patients with obstructive sleep apnea syndrome? J Chin Med Assoc. 2014 Jun;77(6):283-9. doi: 10.1016/j.jcma.2014.02.015. Epub 2014 Apr 14.
- Pang F, Deng W, Huang J, Guo Y, Lin M, Zhang X, Liu J. Prediction of Optimal Positive Airway Pressure in Chinese Patients With Obstructive Sleep Apnea. Clin Respir J. 2024 Dec;18(12):e70047. doi: 10.1111/crj.70047.
- Choi JH, Kim EJ, Kim KW, Choi J, Kwon SY, Lee HM, Kim TH, Lee SH, Shin C, Lee SH. Optimal continuous positive airway pressure level in korean patients with obstructive sleep apnea syndrome. Clin Exp Otorhinolaryngol. 2010 Dec;3(4):207-11. doi: 10.3342/ceo.2010.3.4.207. Epub 2010 Dec 22.
- Lee GH, Kim MJ, Lee EM, Kim CS, Lee SA. Prediction of optimal CPAP pressure and validation of an equation for Asian patients with obstructive sleep apnea. Respir Care. 2013 May;58(5):810-5. doi: 10.4187/respcare.01860.
- Sarma L, Putti N, Alias K, Chilana M. Determination of equation for estimating continuous positive airway pressure in patients with obstructive sleep apnea for the Indian population. Lung India. 2020 Sep-Oct;37(5):411-414. doi: 10.4103/lungindia.lungindia_322_19.
- Bamagoos AA, Alshaynawi SA, Gari AS, Badawi AM, Alhiniah MH, Alshahrani AA, Rajab RR, Bahaj RK, Alhejaili F, Wali SO. Optimal positive airway pressure requirement and polysomnography indices of obstructive sleep apnea severity in the Saudi population. Ann Thorac Med. 2023 Jan-Mar;18(1):31-38. doi: 10.4103/atm.atm_183_22. Epub 2023 Jan 25.
- Ebben MR, Narizhnaya M, Krieger AC. A new predictive model for continuous positive airway pressure in the treatment of obstructive sleep apnea. Sleep Breath. 2017 May;21(2):435-442. doi: 10.1007/s11325-016-1436-7. Epub 2016 Nov 22.
- Saiphoklang N, Leelasittikul K, Pugongchai A. Prediction of optimal continuous positive airway pressure in Thai patients with obstructive sleep apnea. Sci Rep. 2021 Jul 6;11(1):13935. doi: 10.1038/s41598-021-93554-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TUH-EC-OO-0-031/68
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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