SleepI-MASQNCT06215573
Effect of a Novel Melatonin Supplement on Sleep Quality
A study testing Melatonin in people with Sleep, run by University of Exeter at 1 site in United Kingdom.
Trial 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 improved sleep quality following melatonin supplementation before bed. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2023to 18 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Aged 18-40
- Sometimes have trouble sleeping (Pittsburgh sleep quality index score >5)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sport & Health Sciences University of Exeter
Exeter, Devon, EX1 2LU
About this study
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 improved sleep quality following melatonin supplementation before bed. However, it is not known whether such supplements actually increase blood melatonin above normal levels, particularly at night.
The aims of this study are to investigate whether a novel melatonin supplement (Ritual Sleep BioSeriesTM Melatonin) can increase blood melatonin in human participants at night, and to determine if taking the supplement before bed for two-weeks can improve sleep quality.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
5mg melatonin supplement, once daily, from Ritual BioSeries
Placebo supplementDietary supplement
Placebo supplement, once daily, from Ritual BioSeries
| Study group | Role | What they receive |
|---|---|---|
| Melatonin supplementation | Experimental | 5mg melatonin supplement from Ritual Inc's BioSeries Receives: Dietary Supplement: Melatonin |
| Placebo supplementation | Placebo comparator | Placebo supplement from Ritual Inc. Receives: Dietary Supplement: Placebo supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic
Serum melatonin concentration area under curve
Measured: 10 hours
Sleep efficiency
Sleep efficiency, as total time asleep as percentage of time in bed
Measured: 2 weeks
Secondary outcomes (3)
Sleep diary
Sleep diary recorded daily via 'consensus sleep diary - core'
Measured: 2 weeks
Recovery and well being
Recovery and well being recorded via recovery stress questionnaire (REST-Q)
Measured: 2 weeks
Sleep quality
Sleep quality determined via 'Pittsburgh Sleep Quality Index survey'
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start4 Dec 2023
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised cross over trial counterbalanced for trial order
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- Ritual Inc.
- Responsible party
- Sponsor
- Investigators
- Francis B Stephens, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215573
- Sponsor's protocol ID
- WT4634027_I-MASQ v2.0
- Acronym
- I-MASQ
- Status last verified
- Mar 2025
- First submitted
- 10 Jan 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Melatonin Supplement on Sleep Quality
- ClinicalTrials.gov ID
- NCT06215573
- Acronym / sponsor ID
- I-MASQ / WT4634027_I-MASQ v2.0
- Conditions
- Sleep
- Keywords
- melatonin, pharmacokinetics, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- Ritual Inc.
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 improved sleep quality following melatonin supplementation before bed. However, it is not known whether such supplements actually increase blood melatonin above normal levels, particularly at night.
The aims of this study are to investigate whether a novel melatonin supplement (Ritual Sleep BioSeriesTM Melatonin) can increase blood melatonin in human participants at night, and to determine if taking the supplement before bed for two-weeks can improve sleep quality.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised cross over trial counterbalanced for trial order
| Arm | Type | Receives |
|---|---|---|
| Melatonin supplementation | Experimental | Dietary Supplement: Melatonin5mg melatonin supplement from Ritual Inc's BioSeries |
| Placebo supplementation | Placebo comparator | Dietary Supplement: Placebo supplementPlacebo supplement from Ritual Inc. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Aged 18-40
- Sometimes have trouble sleeping (Pittsburgh sleep quality index score >5)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin5mg melatonin supplement, once daily, from Ritual BioSeries | Dietary supplement | Melatonin supplementation |
| Placebo supplementPlacebo supplement, once daily, from Ritual BioSeries | Dietary supplement | Placebo supplementation |
Primary outcome
Pharmacokinetic
Time frame: 10 hours
Serum melatonin concentration area under curve
Sleep efficiency
Time frame: 2 weeks
Sleep efficiency, as total time asleep as percentage of time in bed
3 secondary outcomes
Sleep diary
Time frame: 2 weeks
Recovery and well being
Time frame: 2 weeks
Sleep quality
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis B Stephens, PhD principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Sleep, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (time frame: 10 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.