Pilot Study of Urine Melatonin Measurement.

• Research type

  Research Study

• Full title

  Pilot Study of Urine Melatonin Measurement.

• IRAS ID

  243965

• Contact name

  David O'Regan

• Contact email

  david.oregan@closedloopmedicine.com

• Sponsor organisation

  Closed Loop Medicine

• Duration of Study in the UK

  0 years, 4 months, 0 days

• Research summary

  The main aims of this study are to assess feasibility of participants:

  1. Wearing light-monitoring device
  2. Inputting data relating to their sleep into a mobile phone application
  3. Measuring their urine sulfatoxymelatonin using a simple home test

  Melatonin is the hormone of darkness, and promotes sleep. It rises in late evening, peaks in the middle of the night, and drops back down to baseline by morning. Light impacts melatonin; it is produced in darkness, and inhibited by bright light.

  Melatonin is often prescribed to patients with sleep difficulties. Currently it is done blindly, without knowing the patient’s melatonin level or light exposure.

  For example, we do not know if patients who have low melatonin levels are more likely to respond to melatonin tablets. It is also not understood how co-existing conditions (e.g. anxiety or pain) impact on melatonin levels.

  Measuring urine melatonin is currently not undertaken. We have developed a simple urine self-test which can do this. As it is not practical to measure peak melatonin in the middle of the night, we will measure its principal metabolite i.e. sulfatoxymelatonin. Research has shown that measuring morning sulfatoxymelatonin provides a good surrogate of overnight levels.

  As light impacts on melatonin levels, we will ask participants to wear a light monitoring device (size of a 2p coin; worn like a badge) to undertake this.

  Finally, we will ask participants to input their sleep timings into a mobile phone application. This will replace the paper sleep diaries that people are usually asked to keep as part of any sleep study.

  We plan to recruit participants from medical settings. For this study, participants may or may not have sleep conditions, as well as other conditions.

  In the long-term (outside the scope of this study), we are interested in whether modifying melatonin and light exposure could be used therapeutically to improve sleep.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  19/SC/0054

• Date of REC Opinion

  16 Apr 2019

• REC opinion

  Further Information Favourable Opinion