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NCT07160868Recruiting

Obstructive Sleep Apnoea and Difficult Asthma (OSADA)

Open-label Randomized Controlled Trial Investigating the Relationship Between Obstructive Sleep Apnoea and Difficult Asthma

Source: ClinicalTrials.gov · Last updated 26 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
24 Aug 2025
Start date
1 Sept 2025
Primary completion date
22 May 2026
Lead sponsor
St. James's Hospital, Ireland
Diseases
Asthma
NCT number
NCT07160868

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 1 Sept 2025 to the primary completion date, 22 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with previous sleep study investigations
  • Previous diagnosis of a sleep disorder
  • Resting hypoxaemia or need for long-term oxygen therapy

Other

  • Excessive daytime sleepiness; ESS \>17
  • Inability to provide informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. James's Hospital
Coordinator of this site? Confirm its status
DublinIrelandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.