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

3 luglio 2026 aggiornato da: Anas Mohamed Hamdan Ali, Assiut University

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

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

80

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Epworth Sleepiness Scale (ESS) Score
Lasso di tempo: 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.
Baseline and 1 month post CPAP initiation

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) Score
Lasso di tempo: Baseline and 1 month post CPAP initiation
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.
Baseline and 1 month post CPAP initiation

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

3 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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