Assessing subcutaneous melatonin with in-vivo microdialysis
Research type
Research Study
Full title
Measurement of subcutaneous melatonin in healthy volunteers by in-vivo microdialysis
IRAS ID
193298
Contact name
Katharina Wulff
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 2 months, 1 days
Research summary
The circadian (body) clock is a fundamental biological process widely observed across different organisms. It follows an approximately 24-hour cycle and, in humans, regulates important functions including our sleep-wake patterns, physiology and behaviour. Melatonin is a hormone considered to be the most reliable marker of the circadian clock in humans. However, current practice to sample melatonin (e.g., blood, saliva, urine sampling) disrupt sleep and, in the case of out-of-clinic home studies, rely on the compliance of participants to repeatedly collect saliva/urine samples at low resolution, and is often limited to the waking period.
This study aims to address these limitations by adopting a novel automated sampling system that collects measurements at high resolution and can eventually be used outside of the clinic in the home environment of participants and patients. This would allow us to study physiological fluctuations and disorders that were previously not feasible to study in detail.
We hope this pilot study will help us to understand more about how melatonin and other hormones vary in healthy participants across the circadian cycle. Therefore, we will conduct the pilot study in a clinical research facility under controlled conditions for a period of 26 hours. The novel sampling system uses an approach called microdialysis to automatically measure hormone levels over a short period of time. We will compare this to samples taken from blood, which will allow us to validate the use of automated microdialysis, a safe and easier to use method, and determine if this approach can provide results that are comparable to standard blood sampling.
In addition to these fluid measurements we will collect additional measures (including polysomnography, actigraphy and sleep diaries) in order to link metabolic measures to the sleep-wake cycle. The duration of the overall study participation is therefore 8 days for each participant.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0440
Date of REC Opinion
6 Sep 2016
REC opinion
Favourable Opinion