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临床试验/NCT07693101
NCT07693101尚未招募不适用

Clinical Outcomes of Empirical CPAP Therapy in Suspected Obstructive Sleep Apnea Patients in a Resource-Limited Setting: Observational Cohort Study

Assiut University0 个研究点目标入组 80 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Change in Epworth Sleepiness Scale (ESS) Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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 ≥
  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in Epworth Sleepiness Scale (ESS) Score

时间窗: Baseline and 1 month post CPAP initiation

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.

次要结局

  • Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) Score(Baseline and 1 month post CPAP initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anas Mohamed Hamdan Ali

Resident Of Chest Diseases

Assiut University

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