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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Ellie Daly
+44 (0)1865 225205
ellie.daly@ndm.ox.ac.uk


Dr Swapna Mandal
+44 (0)7387586126
swapnamandal@nhs.net


Dr Patrick Murphy
+44 (0)20 7188 7727
Patrick.Murphy@gstt.nhs.uk


Study Location:

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Be Part of Research - Trial Details - Exacerbation prevention in patients with both chronic obstructive pulmonary disease and obstructive sleep apnoea
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Exacerbation prevention in patients with both chronic obstructive pulmonary disease and obstructive sleep apnoea

Recruiting

Open to: All Genders

Age: Adult

Sheffield London Gloucester Leeds London London Cleveland Birmingham Wakefield Newcastle upon Tyne Oxford

Medical Conditions

Respiratory

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Patients with chronic obstructive pulmonary disease-obstructive sleep apnoea (COPD-OSA) overlap syndrome have higher rates of COPD exacerbations compared to patients with similar severity COPD without OSA. It is currently unknown whether treating OSA in those with COPD-OSA overlap reduces COPD exacerbation rates. The randomised controlled trial will aim to determine whether giving PAP therapy to patients with COPD-OSA overlap will reduce exacerbations of COPD. Patients with COPD-OSA overlap will be randomised into one of two groups: a) PAP therapy in addition to usual care for COPD compared to b) Usual care for COPD alone.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Mar 2025 31 Oct 2026

Participants will be randomised to receive home positive airway pressure (PAP) and COPD usual care or COPD usual care alone with a 12-month follow-up period with an internal pilot.

Usual Care Arm:
If randomised to usual care the following information/advice and management will be delivered: as per NICE (https://www.nice.org.uk/guidance/ng115/resources/chronic-obstructive-pulmonary-disease-in-over-16s-diagnosis-and-management-pdf-66141600098245) and local guidance. This will include as a minimum: a review of pharmacotherapy and consideration of regular, triple-inhaled bronchodilator therapy (long-acting β-agonist, long-acting anti-muscarinic, and steroid), antibiotic prophylaxis, as-needed inhaled short-acting β-agonist therapy, sputum clearance techniques where appropriate, smoking cessation support, pulmonary rehabilitation and education on COPD self-management including non-pharmacological management of COPD, including vaccination additionally advice on sleep quality will be given.

Intervention Arm:
PAP therapy for participants in the intervention arm will be delivered according to local site clinical protocols. All centres involved in the study will be asked for SOPs as part of the process evaluation. Where SOPs are not available senior members of the team will be interviewed to understand the local pathway. As a minimum, the following would be expected for device setup:
1. Face-to-face assessment for mask fitting and device training
2. Mask fit and PAP tolerance check
3. Use of humidification according to patient preference and symptom tolerance
4. Remote review within 1st 30 days to check compliance, troubleshoot technical issues, review mask fit and leak

All participants will undergo face-to-face assessments at 3- and 12-months following randomisation and will complete outcome measures assessments. Trial visits will occur ± 14 days from the scheduled date. Telephone calls will be made monthly (a minimum of 3 attempts will be made over at least three days of the scheduled period of follow-up, after which this the visit will be classed as a missed visit) to collect health care utilisation and PAP therapy (if in the intervention group) data and will be verified at the face-to-face visits.


Patients with moderate-severe COPD (GOLD grade 2-4), high risk of future exacerbations: 1 severe (hospital assessed) exacerbation or 2 moderate (community clinician assessed) in the last 12 months, and moderate-severe OSA (AHI ≥ 15/h)

You can take part if:



You may not be able to take part if:


1. Clinically significant or severe daytime sleepiness: Epworth Sleepiness score > 15 or excessive sleepiness likely to impair safe driving in current drivers (as evidence has already established that such patients should be treated with PAP therapy) 2. Significant hypercapnic respiratory failure at baseline assessment (PaCO2 > 6kPa, with evidence already indicating these patients should be treated with NIV) 3. PAP therapy mandated by the treating clinician due to the severity of the sleep symptom burden4. Professional driver or other vigilance essential role with significant daytime sleepiness 5. Currently enrolled in an interventional clinical trial


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Northern General Hospital
    Sheffield Teaching Hospitals NHS Foundation Trust Herries Road
    Sheffield
    S5 7AU
  • Royal Free Hospital
    Royal Free London Nhs Foundation Trust Pond Street
    London
    NW3 2QG
  • Gloucestershire Royal Hospital
    Gloucestershire Hospitals NHS Foundation Trust Great Western Road
    Gloucester
    GL1 3NN
  • St James's Hospital
    Leeds Teaching Hospitals NHS Trust Beckett Street
    Leeds
    LS9 7TF
  • St Bartholomew’s Hospital
    Barts Health NHS Trust West Smithfield
    London
    EC1A 7BE
  • St Thomas' Hospital (Leading sponsor site)
    Guy's and St Thomas' NHS foundation trust Westminster Bridge Road
    London
    SE1 7EH
  • James Cook University Hospital
    South Tees Hospitals NHS Foundation Trust Marton Road Middlesbrough
    Cleveland
    TS3 4BW
  • Birmingham Heartlands Hospital
    University Hospitals Birmingham NHS Foundation Trust Bordesley Green East
    Birmingham
    B9 5SS
  • Pinderfields General Hospital
    Mid Yorkshire Teaching NHS Trust Aberford Road
    Wakefield
    WF1 4DG
  • Freeman Hospital
    Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • John Radcliffe Hospital
    Oxford University Hospitals NHS Foundation Trust Headley Way Headington
    Oxford
    OX3 9DU

Using PAP therapy may reduce participants' risk of having another flare-up of their breathing and improve sleep quality and quality of life. Taking part in the study will help us understand whether PAP therapy is or is not beneficial to patients with COPD and OSA who are at high risk of having repeated exacerbations of their COPD.
All patients taking part in the study will benefit from regular visits with the research team who are experienced in supporting patients with COPD.
Potential risks/side effects of PAP therapy include:
• Skin irritation: the mask can irritate the skin where it is applied. You will be provided with training to fit the mask appropriately to reduce this risk.
• Dry nose, mouth and eyes: The flow of air from the PAP device can sometimes cause drying of the nose, mouth or eyes. This is more common if there is a significant leak from the mask so it will be important to have training to reduce this. Participants will also be offered additional humidification of the air to reduce this problem. Rarely (<5%) nose bleeds can occur following starting PAP.
• Runny nose: It is common when starting PAP therapy to develop a runny nose. This is usually mild and resolves without any treatment but may need treatment with a nasal spray.
• Claustrophobia: Some people can find the mask claustrophobic.
• Swallowing air (called aerophagia): When using the machine, you can sometimes swallow some of the air causing burping or slight discomfort.
All patients receive current “best practice” therapy. All the tests involve little/no discomfort, other than the time taken to perform them. The blowing tests may feel uncomfortable as they require some effort but are safe.
This study will require time and commitment from the patients enrolled, which the research team appreciate and are very grateful for. There are three face-to-face study visits (at the start of the study, 3 months later and at the end of the study at 12 months). These face-to-face visits will take approximately 45 minutes. There are also monthly telephone calls which should take 10 minutes each. All participants will be closely followed up by the research team who are experienced in the management of patients with COPD and OSA.
Other potential risks of taking part in the study are felt to be low but could include:
• Distress if you are unable to comply with the PAP treatment or follow-up plans that are part of the trial
• Data risks: Data are collected about participants and their health. These data are collected and stored in line with data protection and clinical trial guidance to reduce the risks but data may be accessed by individuals not directly involved in your care or the trial.

Dr Ellie Daly
+44 (0)1865 225205
ellie.daly@ndm.ox.ac.uk


Dr Patrick Murphy
+44 (0)20 7188 7727
Patrick.Murphy@gstt.nhs.uk


Dr Swapna Mandal
+44 (0)7387586126
swapnamandal@nhs.net



The study is sponsored by Guy's and St Thomas' NHS Foundation Trust and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN13475234

Or CPMS 65205

Last updated 10 April 2025

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