Empirical CPAP Therapy for Suspected Obstructive Sleep Apnea in a Resource-Limited Setting

NCT07693101 | Not Yet Recruiting

• 1 other identifier: Outcome of Empiric CPAP in OSA
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA); Suspected Obstructive Sleep Apnea; Sleep Apnea Syndromes

Keywords

Obstructive Sleep Apnea; OSA; Continuous Positive Airway Pressure; CPAP; Auto-CPAP; Empirical Therapy; Empirical CPAP; Polysomnography; Resource-Limited Setting; STOP-BANG; Epworth Sleepiness Scale

Outcome Measures

Primary Outcomes (1)

• Change in Epworth Sleepiness Scale (ESS) Score

  The Epworth Sleepiness Scale (ESS) is used to assess daytime sleepiness. It consists of 8 specific situations where the patient rates their chance of dozing on a scale from 0 (would never doze) to 3 (high chance of dozing). The total score is calculated by summing the item responses, resulting in a possible range of 0 to 24. Higher scores indicate higher levels of daytime sleepiness, with scores of 10 or greater suggesting excessive sleepiness that may require medical attention. This outcome will report the change in the total ESS score to evaluate clinical improvement.

  Baseline and 1 month post CPAP initiation

Secondary Outcomes (1)

• Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) Score

  Baseline and 1 month post CPAP initiation

Study Arms (1)

Suspected OSA Patients on Empirical Auto-CPAP

Adult patients (aged 18 years and older) presenting with symptoms suggestive of Obstructive Sleep Apnea (OSA) and a high clinical probability of the disease, defined as having a STOP-BANG score of 5 or greater, or a STOP-BANG score of 3-4 combined with an Epworth Sleepiness Scale (ESS) score of 10 or greater. These patients are currently awaiting a diagnostic polysomnography (PSG) due to delayed access to sleep laboratory services. Participants in this cohort will be started on empirical Auto-CPAP therapy with a practical pressure range of 6-14 mmHg to evaluate symptom improvement and pressure agreement while they wait for their final PSG and optimal CPAP titration.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (aged 18 years and older) attending the Chest Department at Assiut University Hospital who present with symptoms suggestive of Obstructive Sleep Apnea (OSA), such as excessive daytime sleepiness, habitual snoring, or witnessed apnea. Eligible patients must have a high clinical probability of OSA, defined as having a STOP-BANG score of 5 or greater, or a STOP-BANG score of 3 to 4 combined with an Epworth Sleepiness Scale (ESS) score of 10 or greater. Furthermore, the population is specifically composed of individuals who are currently awaiting diagnostic polysomnography (PSG) due to delayed access to sleep laboratory services in a resource-limited setting.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Of Chest Diseases

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07