FIBRotic Interstitial Lung Disease and Nocturnal OXygen (FIBRINOX)

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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea; Idiopathic Pulmonary Fibrosis; Sleep Disturbance; Sleep Hypoventilation

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 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.

• Study Type: Observational
• Enrollment (Anticipated): 102

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE19RT
    • Recruiting
    • Guy's and St Thomas' NHS Foundation Trust
    • Contact: Katheirne J Myall, MBChB; Phone Number: 85834 02071887188; Email: katherine.myall@gstt.nhs.uk
  • London, United Kingdom, SW36NP
    • Recruiting
    • Royal Brompton Hospital
    • Contact: Philip Molyneaux, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with fibrotic interstitial lung disease

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		12 months
Forced vital capacity (FVC)	Annualised decline in FVC in patients with nocturnal hypoxaemia vs those without	12 months
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
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
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
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
Exacerbation frequency and hospitalisation		12 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Alex West, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2018
• Primary Completion (ANTICIPATED): May 30, 2021
• Study Completion (ANTICIPATED): May 30, 2021

Study Registration Dates

• First Submitted: December 17, 2018
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Lung Diseases; Dyssomnias; Parasomnias; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Hypoventilation
• Other Study ID Numbers: Fibrinox 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be collected on paper worksheets filed in the site file and web-based electronic clinical record forms provided by Castor EDC, a secure web database which is compliant with GCP regulations, Annex 11 and 21 CFR part 11. It also complies with EU GDPR. All communication to servers is encrypted using TLS (1.1 or 1.2) through HSTS.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No