Actively Recruiting
Open-label Randomized Controlled Trial Investigating the Relationship Between Obstructive Sleep Apnoea and Difficult Asthma
Led by St. James's Hospital, Ireland · Updated on 2026-05-26
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
St. James's Hospital, Ireland
Lead Sponsor
T
Tallaght University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on asthma control in adults with difficult-to-control asthma. This open-label, randomized controlled trial focuses on patients who have persistent asthma symptoms despite high-dose inhaler use and explores how OSA may contribute to their condition. The study aims to clarify the role of OSA in asthma management and examine whether treating OSA can improve asthma control, symptom burden, quality of life, and reduce exacerbations and healthcare use. Participants will undergo home-based sleep studies to detect OSA and then be assigned to one of three groups: asthma patients without OSA, asthma patients with OSA who do not receive treatment, and asthma patients with OSA who receive treatment using continuous positive airway pressure (CPAP) therapy at night. The treatment group will use the CPAP device to manage sleep apnoea while monitoring their asthma symptoms and lung function over the study period. Throughout the 3-4 month study, participants will track airflow variability using home electronic peak flow monitoring and report on asthma control and symptoms. Researchers will collect data on asthma exacerbations, lung function, airway inflammation, sleep quality, and healthcare utilization. The study includes regular assessments to evaluate the effects of CPAP treatment on asthma outcomes compared to untreated OSA and patients without OSA.
CONDITIONS
Brief Title
Obstructive Sleep Apnoea and Difficult Asthma (OSADA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a clinical diagnosis of asthma supported by objective tests such as airway obstruction, bronchial hyper-responsiveness, or evidence of eosinophilic inflammation
- Patients must be receiving step 4 or step 5 treatment according to the Global Initiative for Asthma (GINA) guidelines
- Participants must be between 18 and 90 years old
You will not qualify if you...
- Patients who have had previous sleep study investigations
- Patients with excessive daytime sleepiness, defined as an Epworth Sleepiness Score greater than 17
- Patients with a previous diagnosis of any sleep disorder
- Patients with resting low oxygen levels or those requiring long-term oxygen therapy
- Patients unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo home sleep studies to determine the presence and severity of obstructive sleep apnoea (OSA).
1 home sleep study
Duration - 3 to 4 months
Participants are monitored for airflow variability, asthma control, lung function, and markers of airway inflammation over a 3- to 4-month period.
Regular home monitoring and assessments
Duration - 3 to 4 months
Participants diagnosed with OSA and randomized to treatment receive continuous positive airway pressure (CPAP) therapy at night while continuing monitoring of asthma and respiratory measures.
Daily CPAP use with ongoing home monitoring
Trial Site Locations
Total: 1 location
1
St. James's Hospital
Dublin, Dublin, Ireland
Actively Recruiting
Research Team
L
Laura Piggott, BM BS BSc MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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