FIBRINOX
Research type
Research Study
Full title
FIBrotic Interstitial Lung Disease and Nocturnal OXygen - An observational study of the effects of nocturnal hypoxaemia on patients with fibrotic interstitial lung disease
IRAS ID
234305
Contact name
Elizabeth Bruna
Contact email
Sponsor organisation
Guys and St Thomas' NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The interstitial lung diseases are a group of diseases in which patients develop uncontrolled scarring (called fibrosis) within the lung. This causes failure of the lung and patients become progressively more breathless over time. The commonest of these diseases is idiopathic pulmonary fibrosis and this is a devastating condition with a survival of 3-5 years.
Many people with fibrotic interstitial lung diseases have disrupted sleep as well as low oxygen levels at night or obstructive sleep apnoea (OSA - pauses in breathing at night time due to obstruction of the upper airway).
Patients with low oxygen levels at night have a worse quality of life, with fatigue during the day and survive for less long.
We will recruit 102 patients from our specialist clinics at Guy's and St Thomas' and the Royal Brompton and Harefield NHS Foundation Trusts. This research is funded by a grant from the British Lung Foundation. We aim to compare patients with and without low oxygen levels at night by observing how their disease and quality of life changes over a year.
We will ask patients to complete a two-night home sleep study which will involve wearning a probe over the finger connected to a sensor on the wrist. Patients will also be provided with a home spirometer to measure their breathing at home daily during the study.
They will also have lung function testing (which is part of normal clinical practice), perform a six-minute walk test and complete quality of life questionnaires at the beginning of the study. We will then repeat those investigations at six and twelve months and this will tell us how night time oxygen levels affect the progression of the disease, quality of life, exercise tolerance, hospitalisation frequency and survival of these patients.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0615
Date of REC Opinion
7 Nov 2018
REC opinion
Favourable Opinion