Clinical trial Recruiting at 1 site Interventional Ages 18 to 90

Treating obstructive sleep apnoea in people with difficult-to-control asthma

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

Run by St. James's Hospital, Ireland · NCT07160868 · Data updated 2026-11-12

We will see if treating obstructive sleep apnoea with CPAP helps adults with difficult-to-control asthma improve their symptoms, asthma control, and quality of life.

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment80 (estimated)
SponsorSt. James's Hospital, Ireland
Academic / other
Locations1 site (Dublin, Dublin)
StatusRecruiting
StartedSeptember 1, 2025
Main results expectedMay 22, 2026
Study endsMay 22, 2026
Registry record updatedMay 26, 2026
Trial IDNCT07160868 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–90 with difficult-to-control asthma on GINA step 4–5 therapy who have not had prior sleep studies and can give informed consent are the ideal candidates.

Probably not a fit

Patients without OSA, those with prior sleep study or established sleep disorder, those with excessive daytime sleepiness (ESS >17), or resting hypoxaemia are unlikely to benefit from CPAP within this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized controlled trial enrolling adults with difficult-to-control asthma who undergo home sleep testing for obstructive sleep apnoea (OSA). Participants found to have OSA are randomized to CPAP treatment or no CPAP, while those without OSA form a reference group. The study will compare asthma control, symptom burden, and quality of life as primary outcomes, with secondary outcomes including exacerbation rates, sleep quality, and healthcare use. Participants are recruited from Difficult Asthma clinics and must be on GINA step 4–5 therapy and meet other eligibility criteria.

Why it matters

Potential benefit: If successful, diagnosing and treating OSA could improve asthma control, reduce symptoms and exacerbations, and lower healthcare use for people with difficult-to-control asthma.

How similar studies have gone: Some observational studies suggest treating OSA can help asthma outcomes, but randomized evidence is limited and this randomized open-label approach is relatively novel in difficult asthma cohorts.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • St. James's Hospital
    Dublin, Dublin, Ireland
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.