Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea; Asthma
• Interventions: Other: Hygienic and dietary advice; Device: CPAP treatment

• Registration Number: NCT06314477
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)

Detailed Description

Background: The prevalence of obstructive sleep apnea (OSA) is high in patients with severe uncontrolled asthma and can worsen asthma control. Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma. Nevertheless, there are no studies in patients with severe uncontrolled asthma.

Primary objective: To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and AOS.

Methodology: Multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (Epworth sleepiness scale score ≤10). All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (AHI) ≥15/hour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus CPAP. Monitoring will be carried out during12 months. Patients will be evaluated at inclusion, at 1 month, 6 and 12 months.

Study Timeline

• Study Start: 2023-12-27
• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Age >18 years
• Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study.
• Punctuation in the Epworth Sleepiness Scale ≤10
• Obtaining informed consent.

Exclusion Criteria

• Previous treatment with CPAP
• Patient with central sleep apnea or Cheyne-Stokes respiration
• Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,
• Resistant hypertension
• Active Smoking
• Unstable comorbidities or medications may interfere with asthma control
• Pregnancy
• Any process that reduces life expectancy to <1 year,
• Any medical or social factor that may limit CPAP compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Hygienic and dietary advice	Subjects allocated to this arm will receive hygienic and dietary measures counselling
CPAP treatment	CPAP treatment	Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP)

Primary Outcome Measures

Name	Time	Method
Asthma control test	12 months	To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)
Asthma control questionnaire	12 months	To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)

Secondary Outcome Measures

Name	Time	Method
Lung function-forced vital capacity (FVC) in spriometry	12 months	To evaluate the impact of CPAP treatment on FVC (ml) on spirometry
Inflammatory profile	Baseline and 12 months	Plasma proteins from peripheral blood samples will be used to analyze an inflammatory panel using a high-throughput, multiplex immunoassay technology based on Proximity Extension Assays (PEA) at baseline and after CPAP treatment
Lung function- forced expiratory volume in the first second (FEV1) in spirometry	12 months	To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry
Prevalence of OSA in severe uncontrolled asthma	Baseline	Determine the prevalence of OSA in patients with severe uncontrolled asthma
Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)	12 months	Study whether OSA ans its treatment affects quality of life in subjects with severe uncontrolled asthma based on the punctuation obtained in the mini-AQLQ questionnaire. Higher scores indicate better quality of life

Trial Locations

Locations (1)

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain