Obstructive Sleep Apnoea and Difficult Asthma (OSADA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorSt. James's Hospital, Ireland
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Continuous positive airway pressure (CPAP)
Treatment groups
80 Participants
are divided into 3 treatment groupsSponsors and collaborators
St. James's Hospital, Ireland
Lead sponsor
Tallaght University Hospital
Collaborator
Source ClinicalTrials.gov