Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04586946
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2018-12-17
Brief Title:
FIBRotic Interstitial Lung Disease and Nocturnal OXygen
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
An Observational Study of the Effects of Nocturnal Hypoxaemia on Patients With Fibrotic Interstitial Lung Disease
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBRINOX
Brief Summary:
Home sleep studies - which allow the measurement of breathing while the person sleeps - will be performed on patients with fibrotic interstitial lung disease attending two of the UKs largest respiratory medicine servicesThe study will investigate at how symptoms and breathing and exercise tests differ between these two groups after 12 months of study
Detailed Description:
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
102 patients from specialist clinics at Guys and St Thomas and the Royal Brompton and Harefield NHS Foundation Trusts will be recruited This research is funded by a grant from the British Lung Foundation The investigators 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
Patients will be asked to complete a two-night home sleep study which will involve wearing 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
Lung function testing which is part of normal clinical practice a six-minute walk test and quality of life questionnaires will be performed at the beginning of the study These investigations will be repeated 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
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
102 patients from specialist clinics at Guys and St Thomas and the Royal Brompton and Harefield NHS Foundation Trusts will be recruited This research is funded by a grant from the British Lung Foundation The investigators 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
Patients will be asked to complete a two-night home sleep study which will involve wearing 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
Lung function testing which is part of normal clinical practice a six-minute walk test and quality of life questionnaires will be performed at the beginning of the study These investigations will be repeated 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None