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

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.

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