Recruiting

Obstructive Sleep Apnoea and Difficult Asthma (OSADA)

ClinicalTrials.gov IDNCT07160868

PhaseNA

Enrollment80

SponsorSt. James's Hospital, Ireland

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Asthma (Diagnosis), OSA - Obstructive Sleep Apnea, CPAP Treatment

About this study

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.

Interventions

Device: Continuous positive airway pressure (CPAP) — Continuous positive airway pressure - device to be used at night in the treatment of sleep apnoea

Primary outcomes

Change in airflow variability measured by home electronic peak flow monitoring (3-4 months)

Eligibility information

Inclusion Criteria: * 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 Criteria: * 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

Study locations

St. James's Hospital, Dublin, Dublin Ireland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.