Clinical trial NCT04586946: FIBRotic Interstitial Lung Disease and Nocturnal OXygen
Official title: An Observational Study of the Effects of Nocturnal Hypoxaemia on Patients With Fibrotic Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Obstructive Sleep Apnea
Sleep Disturbance
Sleep Hypoventilation
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2020-10-14
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with fibrotic interstitial lung disease

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life measured by King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
timeFrame: 0 months,12 months
Secondary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: 12 months
measure: Diffusion capacity of the lung for carbon monoxide (DLCO)
timeFrame: 12 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 0 months, 6 months, 12 months
measure: Insomnia Severity Index (ISI)
timeFrame: 0 months, 6 months, 12 months
measure: Six-minute walk test (6MWT)
timeFrame: 0 months 6 months, 12 months
measure: Exacerbation frequency and hospitalisation
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Alex West
role: PRINCIPAL_INVESTIGATOR
References: