Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Obstructive sleep apnea (OSA) is a prevalent sleep disorder associated with severe comorbidities, including an increased risk of cardiovascular events, stroke, and premature mortality. While polysomnography (PSG) remains the gold standard for diagnosing OSA, it is time-consuming, expensive, and not readily accessible in resource-limited settings. The scarcity of sleep study centers often results in months of delay for patients with a high clinical suspicion of OSA, leaving them untreated and at an elevated risk for prolonged morbidity.
This observational cohort study, conducted at the Chest Department of Assiut University Hospital, aims to evaluate the efficacy of empirical Auto-CPAP therapy for patients waiting for diagnostic PSG. Patients presenting with a high clinical probability of OSA will undergo a comprehensive baseline evaluation. This includes a meticulous medical history, clinical examination, and anthropometric measurements to categorize Body Mass Index (BMI). Additional baseline diagnostics include a standard posteroanterior Chest X-Ray and comprehensive laboratory investigations (Lipogram, HbA1C, T3, T4, TSH, CBC, Urea, Creatinine, Liver Function Tests, and Arterial Blood Gases). Furthermore, patients will undergo spirometry testing (using a Zan 300 device) performed according to ATS-ERS 2019 criteria for acceptability and repeatability.
Clinical probability and the impact of daytime sleepiness will be quantified using standardized questionnaires, including the STOP-BANG score, the Epworth Sleepiness Scale (ESS), and the 10-item Functional Outcomes of Sleep Questionnaire (FOSQ-10). Following these baseline assessments, eligible patients will be initiated on empirical Auto-CPAP therapy utilizing a practical pressure range of 6-14 mmHg.
Patients will be monitored to evaluate clinical symptom improvement and quality of life changes during this empirical therapy phase. Once patients are able to undergo their delayed diagnostic PSG, the optimal CPAP titration pressure determined by the formal sleep study will be recorded. The study will analyze the agreement and differences between the initial empirical Auto-CPAP pressures and the final PSG-determined pressures. The data will be analyzed to explore correlations between the optimal pressure requirements and specific patient characteristics, such as BMI, neck circumference, and baseline STOP-BANG scores.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) Score | The FOSQ-10 is a 10-item self-administered questionnaire designed to assess the impact of excessive sleepiness on daily activities across five domains: vigilance, general productivity, social outcomes, intimacy, and activity level. Each item is rated on a 1 to 4 scale, where 1 indicates extreme difficulty and 4 indicates no difficulty performing the activity due to sleepiness or tiredness. The total score is calculated by summing the responses, resulting in a possible range of 5 (maximum impairment) to 20 (no impairment). This outcome will report the change in the total score to evaluate the improvement in quality of life. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and 1 month post CPAP initiation |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |