Asthma, Obstructive Sleep Apnea
Conditions
Brief 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)
Detailed description
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 AOS. 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.
Interventions
DEVICECPAP treatment
Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)
OTHERHygienic and dietary advice
Subjects allocated to this arm will receive hygienic and dietary counselling
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma control questionnaire | 12 months | To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ) |
| Asthma control test | 12 months | To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of OSA in severe uncontrolled asthma | Baseline | Determine the prevalence of OSA in patients with severe uncontrolled asthma |
| Lung function- forced expiratory volume in the first second (FEV1) in spirometry | 12 months | To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry |
| Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire) | 12 months | 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 |
| Inflammatory profile | Baseline and 12 months | 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 |
| Lung function-forced vital capacity (FVC) in spriometry | 12 months | To evaluate the impact of CPAP treatment on FVC (ml) on spirometry |
Countries
Spain
Contacts
Primary ContactMireia Dalmases, MD
Outcome results
None listed