Evaluating CPAP treatment for severe asthma patients with sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effects of Continuous Positive Airway Pressure (CPAP) treatment on asthma control in patients suffering from severe uncontrolled asthma and obstructive sleep apnea (OSA). It is a multicenter, prospective, randomized, controlled clinical trial involving adults over 18 years old who meet specific criteria for asthma severity and sleepiness levels. Participants will undergo polysomnography to confirm OSA and will be randomized to receive either standard treatment or standard treatment plus CPAP for a duration of 12 months, with evaluations at multiple time points.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Clinic Barcelona
  Barcelona, Spain, Spain Recruiting

Study contacts

• Principal investigator: Mireia Dalmases, MD — Hospital Clinic
• Study coordinator: Mireia Dalmases, MD
• Email: mdalmase@clinic.cat
• Phone: +34932275746

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.