Obstructive Sleep Apnoea and Difficult Asthma (OSADA)

NCT07160868 | Recruiting

• 1 other identifier: 4211
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in airflow variability measured by home electronic peak flow monitoring

  Airflow variability will be assessed using peak expiratory flow rate (PEFR) measured with electronic home peak flow meters. Variability will be calculated using the daily amplitude percent mean (DAPM) method. Participants will be asked to record PEFR twice daily (early morning and late afternoon) over the defined period to provide adequate data points. For each day, variability will be calculated using the DAPM formula, and the average daily variability across the collection period will then be derived.

  3-4 months

Secondary Outcomes (4)

• Change in asthma control

  3-4 months

• Change in asthma control

  3-4 months

• Change in asthma control

  3-4 months

• Change in asthma control

  3-4 months

Study Arms (3)

Asthma - no sleep apnoea

NO INTERVENTION

This the group of asthma patients without sleep apnoea

Asthma - sleep apnoea, no treatment

NO INTERVENTION

This the group of asthma patients with sleep apnoea (as defined as AHI ≥10 events per hour recorded) who have been randomized to the no treatment arm

Asthma - sleep apnoea, treatment

EXPERIMENTAL

This the group of asthma patients with sleep apnoea (as defined as AHI ≥10 events per hour recorded) who have been randomized to the treatment arm. They will receive CPAP therapy as treatment for sleep apnoea, while monitoring their asthma control measures and airflow variability.

Device: Continuous positive airway pressure (CPAP)

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Continuous positive airway pressure - device to be used at night in the treatment of sleep apnoea

Asthma - sleep apnoea, treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. James's Hospital, Ireland: lead
• Tallaght University Hospital: collaborator

Study Sites (1)

St. James's Hospital

Dublin, Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Asthma; Disease; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Laura Piggott, BM BS BSc MSc

CONTACT

+353876801786; laurampiggott@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)