Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Clinic of Barcelona
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous treatment with CPAP
Patient with central sleep apnea or Cheyne-Stokes respiration
Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,
Resistant hypertension
Trial design
Design model
Parallel
Treatments tested in this trial
CPAP treatment
DeviceSubjects allocated to this arm will receive continuous positive airway pressure (CPAP)
Hygienic and dietary advice
Other interventionSubjects allocated to this arm will receive hygienic and dietary counselling
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Conservative treatmentActive comparator 1 intervention
Group B: CPAP treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Asthma control questionnaire
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)
Time frame
12 months2
Asthma control test
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)
Time frame
12 monthsSecondary outcomes
1
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 months2
Lung function-forced vital capacity (FVC) in spriometry
To evaluate the impact of CPAP treatment on FVC (ml) on spirometry
Time frame
12 months3
Prevalence of OSA in severe uncontrolled asthma
Determine the prevalence of OSA in patients with severe uncontrolled asthma
Time frame
Baseline4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov