An interventional study of CPAP treatment and Hygienic and dietary advice in Obstructive Sleep Apnea and Asthma, sponsored by Hospital Clinic of Barcelona. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Treatment
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)
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 OSA.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 138 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Hospital Clinic of Barcelona is the lead sponsor of 327 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects allocated to this arm will receive hygienic and dietary measures counselling
Other: Hygienic and dietary advice
Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP)
Device: CPAP treatment
Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)
Subjects allocated to this arm will receive hygienic and dietary counselling
Asthma control questionnaire
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)
Time frame: 12 months
Asthma control test
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)
Time frame: 12 months
Lung function- forced expiratory volume in the first second (FEV1) in spirometry
To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry
Time frame: 12 months
Lung function-forced vital capacity (FVC) in spriometry
To evaluate the impact of CPAP treatment on FVC (ml) on spirometry
Time frame: 12 months
Prevalence of OSA in severe uncontrolled asthma
Determine the prevalence of OSA in patients with severe uncontrolled asthma
Time frame: Baseline
Inflammatory profile
Plasma proteins from peripheral blood samples will be used to analyze an inflammatory panel using a high-throughput, multiplex immunoassay technology based on Proximity Extension Assays (PEA) at baseline and after CPAP treatment
Time frame: Baseline, 6 and 12 months
Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)
Study whether OSA ans its treatment affects quality of life in subjects with severe uncontrolled asthma based on the punctuation obtained in the mini-AQLQ questionnaire. Higher scores indicate better quality of life
Time frame: 12 months
Exacerbations
Number of excarbations the year before starting the study and at 12-month of treatment in both arms
Time frame: From enrollment to the end of the study at 12 months
Plan to share: Yes — Anonymized IPD will be available upon reasonable request following publication of the study results. Requests will be valuated by the study team and be subject to applicable ethical, legal and data portection requeriments.
Supporting information: Study protocol
Time frame: IPD will be available upon reasonable request following publication of the study results.
Access criteria: Access will be granted to qualified researchers for cientifically valid reserach purposes
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Dec 2027, 46 months after the start.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 46 months is above that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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