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

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

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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