Evaluating CPAP treatment for severe asthma patients with sleep apnea
Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea: The ASTHMA-SLEEP Study
NA · Hospital Clinic of Barcelona · NCT06314477
This study is testing if using a CPAP machine can help adults with severe asthma and sleep apnea breathe better and manage their asthma more effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Clinic of Barcelona (other) |
| Locations | 1 site (Barcelona, Spain) |
| Trial ID | NCT06314477 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with severe uncontrolled asthma and an apnea-hypopnea index of 15 or higher.
Not a fit: Patients with central sleep apnea, other significant sleep disorders, or unstable comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve asthma control in patients with severe uncontrolled asthma and OSA.
How similar studies have performed: Previous observational studies have shown promise for CPAP treatment in patients with mild to moderate asthma, but this approach in severe uncontrolled asthma is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona, Spain
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, Asthma