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Recruiting NCT07376343

Comparative Study of CPAP Predictive Equations and In-laboratory Manual Titration in Thai Patients With Obstructive Sleep Apnea

Observational OSA - Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep test, Predictive equations of continuous positive airway pressure (CPAP).
Who it may be relevant to
Registry conditions: OSA - Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

This study is a cross-sectional study involving Thai patients aged 18 years or older with suspected obstructive sleep apnea (OSA). Participants will undergo an in-laboratory sleep study. During the study, sleep technicians will use CPAP predictive equations to estimate the optimal CPAP pressure.

Interventions

  • Diagnostic test Sleep test
    Type 1 polysomnography will be performed in the Sleep Center of Thammasat (SCENT).
  • Other Predictive equations of continuous positive airway pressure (CPAP)
    CPAP predictive equations will be selected based on evidence from reliable studies.

Primary outcome measures

  • Accuracy of CPAP equations in predicting the optimal pressure in OSA patients [Time frame: At baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Thailand · 2 centers
  • Faculty of Medicine, Thammasat University — Pathum Thani
  • Narongkorn Saiphoklang — Pathum Thani

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. PMID 12833183
  • 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. PMID 18797117
  • 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. PMID 23145885
  • 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. PMID 24731756
  • 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. PMID 39716408
  • 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. PMID 21217962
  • 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. PMID 23051618
  • 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. PMID 32883901

Identifiers

NCT: NCT07376343 · TUH-EC-OO-0-031/68

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗