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

H

Hospital Clinic of Barcelona

Status

Enrolling

Conditions

Asthma
Obstructive Sleep Apnea

Treatments

Other: Hygienic and dietary advice
Device: CPAP treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06314477
HCB/2022/1204

Details and patient eligibility

About

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)

Full 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.

Enrollment

138 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

138 participants in 2 patient groups

Conservative treatment
Active Comparator group
Description:
Subjects allocated to this arm will receive hygienic and dietary measures counselling
Treatment:
Other: Hygienic and dietary advice
CPAP treatment
Experimental group
Description:
Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP)
Treatment:
Device: CPAP treatment

Trial contacts and locations

1

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Central trial contact

Mireia Dalmases, MD

Data sourced from clinicaltrials.gov

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