Status:
COMPLETED
Effect of a Novel Melatonin Supplement on Sleep Quality
Lead Sponsor:
University of Exeter
Collaborating Sponsors:
Ritual Inc.
Conditions:
Sleep
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Melatonin is a hormone naturally found in our body that increases in our blood at night and controls how we sleep. Melatonin can also be taken as a pill and numerous clinical trials have documented im...
Eligibility Criteria
Inclusion
- Healthy
- Aged 18-40
- Sometimes have trouble sleeping (Pittsburgh sleep quality index score \>5)
Exclusion
- Routinely taking melatonin supplements or other drugs known to affect sleep
- A diagnosed sleep disorder
- Major psychiatric illness
- Current physical injury
- Known or suspected hypersensitivity to melatonin
- Presence of major sleep disruptors at home (e.g. new born baby)
- Night shift/rotational-shift work
- Receiving non-pharmacological treatment for sleep disorder (e.g. cognitive behavioral therapy)
- Substance use disorder
- Recent (\<1 month) increase in daily caffeinated drink consumption
- Consuming \>14 standard alcoholic drinks per week
- Pregnant or lactating
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06215573
Start Date
December 4 2023
End Date
April 18 2024
Last Update
March 30 2025
Active Locations (1)
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1
Sport & Health Sciences University of Exeter
Exeter, Devon, United Kingdom, EX1 2LU