FIBRotic Interstitial Lung Disease and Nocturnal OXygen

NCT04586946 | Completed

• 1 other identifier: Fibrinox 1.0
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Idiopathic Pulmonary Fibrosis; Obstructive Sleep Apnea; Sleep Disturbance; Sleep Hypoventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Forced vital capacity (FVC)

  12 months

• Diffusion capacity of the lung for carbon monoxide (DLCO)

  12 months

• Pittsburgh Sleep Quality Index (PSQI)

  0 months, 6 months, 12 months

• Insomnia Severity Index (ISI)

  0 months, 6 months, 12 months

• Six-minute walk test (6MWT)

  0 months 6 months, 12 months

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with fibrotic interstitial lung disease

You may qualify if:

• 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

You may not qualify if:

• Presence of an underlying connective tissue disease
• Daytime/resting hypoxaemia with pO2 \<8.0
• Other indication for oxygen therapy
• % 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (2)

Guy's and St Thomas' NHS Foundation Trust

London, SE19RT, United Kingdom

Location

Royal Brompton Hospital

London, sw36np, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted and used to genotype common variants known to be associated with pulmonary fibrosis, including but not limited to Muc5b, TOLLIP and TERT. Serum and plasma will be analysed for solu-ble biomarkers including but not limited to KL-6, SP-A, SP-D, Fas, MMP1, MMP7, clusterin, dynamin, VEGF, CCL18, osteopontin, thrombospondin and inflammatory cytokines. Levels in biomarkers and geno-type frequency will be compared between subgroups of patients

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Sleep Apnea, Obstructive; Parasomnias

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Alex West

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: October 14, 2020
• Study Start: December 17, 2018
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: March 8, 2023

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)