Circadian Therapeutics Sleep Health Study Version 1.1

• Research type

  Research Study

• Full title

  Quantification of circadian rhythms in the Vision Impaired

• IRAS ID

  248419

• Contact name

  Suzanne Ftouni

• Contact email

  suzanne.ftouni@circadiantherapeutics.com

• Sponsor organisation

  Circadian Therapeutics

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  1 years, 2 months, 31 days

• Research summary

  Summary of Research
  Sleep and biological daily rhythms (circadian rhythms) are essential to maintaining the healthy balance and functioning of the mind and body. Our master internal circadian clock coordinates our body’s daily physiological and behavioural cycles to the Earth's solar day – including daytime alertness and sleep timing, to synchronization of changes in hormone secretion and organ activity, to fluctuations in mood and cognitive ability.

  Sleep and circadian rhythm disruption (SCRD), however, is widely experienced in our communities, with the scope of the problem often underreported. Common suffers range from teenagers, new mothers and shift workers, to individuals with depression and the severely Vision Impaired. Critically, SCRD is an underlying, and often undetected, feature in many of the most challenging diseases of our time, including cardiovascular disease, cancer and neuropsychiatric diseases.

  In order to treat SCRD, knowledge of an individual’s circadian time or phase i.e. the body’s internal time is critical to making a definitive diagnosis of underlying disruption, and secondly, to time the delivery of treatment appropriately. However, current gold-standard approaches to circadian measurement are invasive and not feasible for effective monitoring in applied everyday settings.

  In partnership with the Blind Veterans UK (BVUK), we aim to develop new techniques to accurately detect underlying circadian disruption by quantifying robust circadian rhythms in physiological and biological markers, in a sample of Vision Impaired individuals experiencing desynchronised external-internal rhythms.

  Members of BVUK will be invited to participate in a Sleep and Circadian Health Survey. Individuals identified with a risk of abnormal circadian rhythms will be invited to measure their circadian time, requiring the repeated collection of urine samples over 4 weeks to assess rhythmic changes in melatonin, the gold-standard marker of circadian time. Participants will then be invited to BVUK Residential Care Facility for two-days of high-resolution profiling of physiological and biological measures.

  Summary of Research
  A large proportion of vision-impaired individuals report significant sleep disruption. The underlying cause of this disruption is often attributed to biological clock (circadian rhythm) disturbance. The results of our study are two-fold. First, we found that the underlying cause of sleep disturbance in vision-impaired individuals is multifaceted - including health/mental health, aging, and light perception dysfunction - and has demonstrated the importance of identifying the cause of sleep disruption for effective and targeted treatment. Second, the study provided preliminary evidence for application of circadian quantification methods to more simply assess underlying circadian rhythm disturbance

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  18/WM/0290

• Date of REC Opinion

  24 Oct 2018

• REC opinion

  Further Information Favourable Opinion