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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314477
• Other study ID #: HCB/2022/1204
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Hospital Clinic of Barcelona
• Contact: Mireia Dalmases, MD
• Phone: +34932275746
• Email: mdalmase[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control questionnaire	To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)	12 months
Primary	Asthma control test	To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)	12 months
Secondary	Lung function- forced expiratory volume in the first second (FEV1) in spirometry	To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry	12 months
Secondary	Lung function-forced vital capacity (FVC) in spriometry	To evaluate the impact of CPAP treatment on FVC (ml) on spirometry	12 months
Secondary	Prevalence of OSA in severe uncontrolled asthma	Determine the prevalence of OSA in patients with severe uncontrolled asthma	Baseline
Secondary	Inflammatory profile	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	Baseline and 12 months
Secondary	Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)	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	12 months