RecruitingNot Applicable

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

Spain138 participantsStarted 2023-12-27

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Asthma control questionnaire

Timeframe: 12 months

Asthma control test

Timeframe: 12 months

Trial details

NCT IDNCT06314477

SponsorHospital Clinic of Barcelona

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Mireia Dalmases, MD

+34932275746 mdalmase@clinic.cat

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.