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

NCT ID: NCT06314477

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-27
• Study Completion Date: 2026-12-31

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.

Conditions

Obstructive Sleep Apnea; Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CPAP treatment

Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP)

Group Type: EXPERIMENTAL

CPAP treatment

Intervention Type: DEVICE

Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)

Conservative treatment

Subjects allocated to this arm will receive hygienic and dietary measures counselling

Group Type: ACTIVE_COMPARATOR

Hygienic and dietary advice

Intervention Type: OTHER

Subjects allocated to this arm will receive hygienic and dietary counselling

Interventions

CPAP treatment

Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

Hygienic and dietary advice

Subjects allocated to this arm will receive hygienic and dietary counselling

Intervention Type: OTHER

Eligibility Criteria

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.
• Apnea hypopnea rate greater than or equal to 15/hour
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Mireia Dalmases

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mireia Dalmases, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic

Locations

Hospital Clinic Barcelona

Barcelona, Spain, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Mireia Dalmases, MD

Role: CONTACT

mdalmase@clinic.cat

+34932275746

Other Identifiers

HCB/2022/1204

Identifier Type: -

Identifier Source: org_study_id