Melatonin in doctors and nurses working nightshifts

Melatonin In Doctors and nurses working NIGHTshifts (MIDNIGHT): a randomised double-blind placebo-controlled crossover pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15529655

Enrollment

Registered

2016-02-22

Start date

2016-04-01

Completion date

Unknown

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Doctors and nurses working nightshifts Not Applicable

Interventions

Subjects will take 6mg Circadin (slow release melatonin) or a matching placebo on three consecutive days during night shift working on two separate series of night shifts at least 4 weeks apart.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Either sex 2. Non-smokers 3. Not taking regular medicine 4. No health complaints 5. Doctor or nurse working two series of night shifts at least 4 weeks apart

Exclusion criteria

Exclusion criteria: 1. Pregnant or trying to get pregnant 2. Breastfeeding 3. Use of sedatives, hypnotics, herbal remedies, sleeping pills 4. Taking medication except oral contraceptives

Design outcomes

Secondary

Measure	Time frame
1. Determination of drop out, non completion and retention rate (end of trial) 2. Differential gene expression (blood samples on Day 1 before shift, and end of shifts series on Day 4) 3. Differential gene expression between placebo and active arms (blood samples Day 4 after each shift series) 4. Serum interleukin-6 and tumour necrosis factor alpha levels (blood samples on Day 1, and end of shifts series on Day 4) 5. Serum IL-6 and TNFalpha levels after placebo and active arms (blood samples Day 4 after each shift series) 6. Serum melatonin and 6-hydroxymelatonin sulphate levels at each time point (blood samples on Day 1 before shift, and end of each shift for shift series) 7. Verran and Snyder-Halpern sleep scale, Epworth sleepiness scale, data from wristband activity monitor (VSH before each shift, ESS before, during and after each shift. Activity monitoring during each sleep period) 8. Psychomotor vigilance task, double digit addition test (PVT and DDAT before and after each shift) 9. Usual sleep habits and owl-lark questionnaires (before randomisation) 10. Questionnaire about trial (trial end) 11. Focus group about trial (trial end - requires additional consent)	—

Measure

Time frame

1. Determination of drop out, non completion and retention rate (end of trial) 2. Differential gene expression (blood samples on Day 1 before shift, and end of shifts series on Day 4) 3. Differential gene expression between placebo and active arms (blood samples Day 4 after each shift series) 4. Serum interleukin-6 and tumour necrosis factor alpha levels (blood samples on Day 1, and end of shifts series on Day 4) 5. Serum IL-6 and TNFalpha levels after placebo and active arms (blood samples Day 4 after each shift series) 6. Serum melatonin and 6-hydroxymelatonin sulphate levels at each time point (blood samples on Day 1 before shift, and end of each shift for shift series) 7. Verran and Snyder-Halpern sleep scale, Epworth sleepiness scale, data from wristband activity monitor (VSH before each shift, ESS before, during and after each shift. Activity monitoring during each sleep period) 8. Psychomotor vigilance task, double digit addition test (PVT and DDAT before and after each shift) 9. Usual sleep habits and owl-lark questionnaires (before randomisation) 10. Questionnaire about trial (trial end) 11. Focus group about trial (trial end - requires additional consent)

—

Primary

Measure	Time frame
The primary endpoint is successful completion of the trial, defined as recruitment, randomisation and protocol completion of 25 individuals i.e., both arms of the crossover design.	—

Countries

Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026