Empirical CPAP Therapy for Suspected Obstructive Sleep Apnea in a Resource-Limited Setting (NCT07693101) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Empirical CPAP Therapy for Suspected Obstructive Sleep Apnea in a Resource-Limited Setting
80 participantsStarted 2026-08
Plain-language summary
Obstructive sleep apnea (OSA) is a condition where a person's airway repeatedly collapses during sleep, causing them to stop breathing briefly and disrupting their rest. The standard way to diagnose OSA is a formal overnight sleep study called polysomnography (PSG). However, in resource-limited settings, sleep study centers are scarce, which can lead to months of waiting before a patient can be diagnosed and treated. Delaying treatment can negatively affect a patient's quality of life and increase their risk for other health issues.
The purpose of this observational study is to evaluate the clinical benefits of starting continuous positive airway pressure (CPAP) therapy early for patients who are highly suspected to have OSA, while they wait for their formal sleep study.
Researchers will enroll adult patients who have symptoms of OSA (such as loud snoring, witnessed breathing pauses, and severe daytime sleepiness) and a high clinical probability of having the condition. Instead of waiting for the official sleep study to begin treatment, these participants will be provided with an Auto-CPAP machine set to a practical pressure range.
The main goals of the study are to evaluate:
* If this early, empirical Auto-CPAP treatment improves patients' daytime sleepiness and overall quality of life, which will be measured using specialized questionnaires.
* How accurately the temporary Auto-CPAP machine's pressure settings match the final, optimal pressure settings that will eventually be determined by the formal sleep study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years.
* Patients presenting with symptoms suggestive of OSA, including one or more of the following: excessive daytime sleepiness, habitual snoring, witnessed apnea during sleep, non-restorative sleep, or morning headache.
* High clinical probability of OSA defined by: STOP-BANG score ≥5 or STOP-BANG score 3-4 with ESS ≥10.
* Patients awaiting diagnostic PSG due to delayed access to sleep laboratory services.
* Patients with OSAS and COPD overlap.
* Obesity hypoventilation syndrome requiring automated CPAP.
* Ability and willingness to use CPAP and provide informed consent.
Exclusion Criteria:
* Age \<18 years.
* Pregnancy.
* Previous PSG-confirmed OSA with prescribed CPAP settings.
* Predominant central sleep apnea.
* Cheyne-Stokes respiration.
* Neuromuscular disorders affecting respiration.
* Severe psychiatric illness impairing adherence.
* Inability to provide informed consent.
* Severe unstable cardiopulmonary disease requiring urgent respiratory support, including: acute heart failure, acute coronary syndrome, acute respiratory failure, or severe COPD with chronic hypercapnic respiratory failure requiring NIV rather than CPAP.
* Obesity hypoventilation syndrome requiring bilevel PAP (BiPAP) instead of CPAP.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Epworth Sleepiness Scale (ESS) Score
Timeframe: Baseline and 1 month post CPAP initiation