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Recruiting NCT06314477

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

No phase Interventional Obstructive Sleep Apnea Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPAP treatment, Hygienic and dietary advice.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Asthma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea: The ASTHMA-SLEEP Study

Overview

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

  • Device CPAP treatment
    Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)
  • Other Hygienic and dietary advice
    Subjects allocated to this arm will receive hygienic and dietary counselling

Primary outcome measures

  • Asthma control questionnaire [Time frame: 12 months]
  • Asthma control test [Time frame: 12 months]
Secondary outcome measures (5)
  • Lung function- forced expiratory volume in the first second (FEV1) in spirometry [Time frame: 12 months]
  • Lung function-forced vital capacity (FVC) in spriometry [Time frame: 12 months]
  • Prevalence of OSA in severe uncontrolled asthma [Time frame: Baseline]
  • Inflammatory profile [Time frame: Baseline and 12 months]
  • Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire) [Time frame: 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.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Clinic Barcelona — Barcelona

Identifiers

NCT: NCT06314477 · HCB/2022/1204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗