Obstructive Sleep Apnoea and Difficult Asthma (OSADA)
Open-label Randomized Controlled Trial Investigating the Relationship Between Obstructive Sleep Apnoea and Difficult Asthma
St. James's Hospital, Ireland
80 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
Summary
The OSADA (Obstructive Sleep Apnoea in Difficult Asthma) trial is an open-label, randomized control trial investigating the impact of diagnosing and treating obstructive sleep apnoea (OSA) on a asthma control in patients with difficult-to-control asthma. Participants will undergo home-based sleep studies to assess for OSA and are then allocated to one of three arms: 1) Patients with OSA treated with CPAP (intervention group), 2) Patients with OSA not treated for OSA (control group) and 3) Patients without OSA (reference group). The primary objective is to evaluate whether treating OSA improves asthma control, symptom burden, and quality of life compared to untreated OSA and to patients without OSA. Secondary outcomes include exacerbation rates, sleep quality, and healthcare utilization. This trial aims to clarify the contribution of OSA to poor asthma control and the potential benefits of integrated sleep and respiratory care in this complex population.
Eligibility
Inclusion Criteria3
- Patients must have a clinical diagnosis of asthma with supportive objective diagnostics including but not limited to, variable airflow obstruction, bronchial-hyper responsiveness and demonstrable eosinophilic inflammation via fractional exhaled nitric oxide or peripheral eosinophilia
- Patients receiving step 4 or step 5 of 'The Global Initiative for Asthma' (GINA) treatment guidelines will be selected
- Between the ages of 18 to 90 years of age
Exclusion Criteria5
- Patients with previous sleep study investigations
- Excessive daytime sleepiness; ESS \>17
- Previous diagnosis of a sleep disorder
- Resting hypoxaemia or need for long-term oxygen therapy
- Inability to provide informed consent
Interventions
Continuous positive airway pressure - device to be used at night in the treatment of sleep apnoea
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07160868