FIBRotic Interstitial Lung Disease and Nocturnal OXygen

Obstructive Sleep Apnea Clinical Trial

— FIBRINOX  

Official title:

An Observational Study of the Effects of Nocturnal Hypoxaemia on Patients With Fibrotic Interstitial Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04586946
• Other study ID #: Fibrinox 1.0
• Status: Completed
• Start date: December 17, 2018
• Est. completion date: May 30, 2021

Study information

• Verified date: October 2020
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 UK's largest respiratory medicine services.The study will investigate at how symptoms, and breathing and exercise tests differ between these two groups after 12 months of study.

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 Guy's 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• MDT diagnosis of fibrotic interstitial lung disease including but not limited to idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), fibrotic organising pneumonia and unclassifiable fibrotic lung disease.

• Competent to provide written consent in English

Exclusion Criteria:

• Presence of an underlying connective tissue disease

• Daytime/resting hypoxaemia with pO2 <8.0

• Other indication for oxygen therapy

• 3% ODI >15 events/hour studied or established on CPAP

• Predominant emphysema on CT

• Inability to provide informed consent or complete health-related quality of life questionnaires in English

• Current participation in a research project which might alter lung function or sleep study results

Related Conditions & MeSH terms

• Dyssomnias
• Hypoventilation
• Idiopathic Pulmonary Fibrosis
• Lung Diseases
• Lung Diseases, Interstitial
• Obstructive Sleep Apnea
• Parasomnias
• Pulmonary Fibrosis
• Sleep Apnea, Obstructive
• Sleep Disturbance
• Sleep Hypoventilation

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Royal Brompton Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measured by King's Brief Interstitial Lung Disease Questionnaire (K-BILD)	Change in K-BILD score from baseline at 12 months in patients with nocturnal hypoxaemia vs those without (defined as time spent with SpO2<90% of > 10% total sleep time)	0 months,12 months
Secondary	Forced vital capacity (FVC)	Annualised decline in FVC in patients with nocturnal hypoxaemia vs those without	12 months
Secondary	Diffusion capacity of the lung for carbon monoxide (DLCO)	Change in DLCO from baseline at 6 and 12 months in patients with nocturnal hypoxaemia vs those without	12 months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	PSQI score at baseline, and change at 6 and 12 months in patients with nocturnal hypoxaemia vs those without	0 months, 6 months, 12 months
Secondary	Insomnia Severity Index (ISI)	ISI score at baseline, and change at 6 and 12 months in patients with nocturnal hypoxaemia vs those without	0 months, 6 months, 12 months
Secondary	Six-minute walk test (6MWT)	Total distance (in metres) and minimum oxygen saturation during 6MWT at baseline, 6 and 12 months	0 months 6 months, 12 months
Secondary	Exacerbation frequency and hospitalisation	Exacerbation frequency and hospitalisation	12 months
Secondary	Mortality	Mortality	12 months