Circadian disruption v.1
Research type
Research Study
Full title
The pathological effects of circadian disruption
IRAS ID
299053
Contact name
John Blaikley
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
Disruption of sleep and the body’s clock (circadian disruption) are linked to adverse outcomes in many human diseases, including chronic lung diseases. Idiopathic pulmonary fibrosis (IPF) is an incurable lung disease characterized by progressive lung fibrosis (“scarring”), with few treatment options and a median survival of three years in the absence of antifibrotic treatment. Circadian factors are likely to play an important role in the development and progression of IPF.
We plan to investigate the role of circadian disruption in patients diagnosed with IPF, through a comprehensive study in four parts, involving analysis of data stored in large biobanks (such as FinnGen and the UK biobank), a small residential study allowing blood sample collection at four-hourly intervals over a 48-hour period to measure biomarkers of circadian disruption (in 10 IPF patients and 10 non-IPF control participants), a larger study of up to 45 IPF patients followed-up over approximately 52 weeks to determine whether circadian disruption is associated with a faster rate of decline in lung function and a healthy volunteer blood collection group (up to 50 volunteers) to define circadian factors/ mediators. These samples will be stored for further studies in future to maximise their use.
The residential and healthy volunteer study will take place via a clinical research facility (such as MFT CRF) and the long-term study will take place through the MFT NHS interstitial lung diseases (ILD) unit and CRF.
In clinical parts of the study, circadian disruption will be determined through a combination of specific blood biomarkers (genetic, hormonal and metabolic), sleep questionnaires, and accelerometry (recording body movement, sleep duration and related parameters with wearable commercially available devices). Lung function will be performed as part of routine clinical care and at home using certified home spirometers.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
21/NW/0273
Date of REC Opinion
22 Oct 2021
REC opinion
Further Information Favourable Opinion