Clinical trial NCT06314477: Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial
Official title: Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea: The ASTHMA-SLEEP Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Asthma
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.
* 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

Primary outcomes:
measure: Asthma control questionnaire
timeFrame: 12 months
measure: Asthma control test
timeFrame: 12 months
Secondary outcomes:
measure: Lung function- forced expiratory volume in the first second (FEV1) in spirometry
timeFrame: 12 months
measure: Lung function-forced vital capacity (FVC) in spriometry
timeFrame: 12 months
measure: Prevalence of OSA in severe uncontrolled asthma
timeFrame: Baseline
measure: Inflammatory profile
timeFrame: Baseline and 12 months
measure: Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Hospital Clinic
name: Mireia Dalmases, MD
role: PRINCIPAL_INVESTIGATOR
References: