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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Asthma; Obstructive Sleep Apnea
• Intervention / Treatment: Other: Hygienic and dietary advice; Device: CPAP treatment

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 OSA.

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.

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireia Dalmases, MD; Phone Number: +34932275746; Email: mdalmase@clinic.cat

Study Locations

• Spain
  • Spain
    • Barcelona, Spain, Spain, 08036
      • Recruiting
      • Hospital Clinic Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative treatment; Subjects allocated to this arm will receive hygienic and dietary measures counselling	Other: Hygienic and dietary advice; Subjects allocated to this arm will receive hygienic and dietary counselling
Experimental: CPAP treatment; Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP)	Device: CPAP treatment; Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control questionnaire	To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)	12 months
Asthma control test	To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Lung function-forced vital capacity (FVC) in spriometry	To evaluate the impact of CPAP treatment on FVC (ml) on spirometry	12 months
Prevalence of OSA in severe uncontrolled asthma	Determine the prevalence of OSA in patients with severe uncontrolled asthma	Baseline
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, 6 and 12 months
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
Exacerbations	Number of excarbations the year before starting the study and at 12-month of treatment in both arms	From enrollment to the end of the study at 12 months

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Mireia Dalmases, MD, Hospital Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): September 21, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Asthma; Sleep Apnea, Obstructive; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Airway Management; Respiratory Therapy; Positive-Pressure Respiration; Respiration, Artificial; Continuous Positive Airway Pressure; Nutrition Assessment
• Other Study ID Numbers: HCB/2022/1204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Anonymized IPD will be available upon reasonable request following publication of the study results. Requests will be valuated by the study team and be subject to applicable ethical, legal and data portection requeriments.

IPD Sharing Time Frame

IPD will be available upon reasonable request following publication of the study results.

IPD Sharing Access Criteria

Access will be granted to qualified researchers for cientifically valid reserach purposes

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No