SleepNCT06053385
Impact of Commercial "Sleep Lotion" on Salivary Melatonin Levels and Sleep Quality in Undergraduates
A study testing Melatonin sleep lotion in people with Sleep, run by University of Redlands at 1 site in United States.
Trial summary
The goal of this clinical trial is to test an over-the-counter "sleep lotion" in healthy undergraduate college students. The main questions it aims to answer are: Does an over-the-counter "sleep lotion" containing melatonin actually increase melatonin levels in participants compared to a placebo (control) lotion? Does… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Melatonin sleep lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 20 Apr 2023
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 24 years old
- current University of Redlands student
Who cannot join
- Pregnancy
- currently taking any sleep medications
- allergies or sensitivities to scented lotion
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test an over-the-counter "sleep lotion" in healthy undergraduate college students. The main questions it aims to answer are:
- Does an over-the-counter "sleep lotion" containing melatonin actually increase melatonin levels in participants compared to a placebo (control) lotion?
- Does an over-the-counter "sleep lotion" containing melatonin improve the quality of participants' sleep compared to a placebo (control) lotion?
Read more
Participants will:
- provide three saliva samples on each of two nights
- apply melatonin-containing "sleep lotion" on one night and a placebo (control with no melatonin) lotion on the other night
- answer questionnaires about gender, race, ethnicity, medication use, exercise, and sleep quality
Read the detailed description
Melatonin is a hormone secreted by the pineal gland in the brain that regulates sleep. There are many over-the-counter products such as bubble baths, room sprays, and lotions that claim they contain melatonin and promote sleep. This study is a randomized, controlled, double-blind crossover trial to compare the impact of a commercial "sleep lotion" vs. a control lotion on melatonin levels detectable in saliva in healthy undergraduate students. Participants will provide saliva samples on two nights, one week apart, one hour before bedtime. The sample collections will take place just before and twice after applying 1) a melatonin lotion and 2) a placebo control lotion (order randomized). The investigators will determine whether the melatonin lotion affects the natural rise of melatonin before bedtime. A second dependent variable will be the quality of sleep on both nights. Potential confounding independent variables, such as gender, race, ethnicity, medication use, and exercise will also be assessed.
- Conditions
- Sleep
- Being tested
- Melatonin sleep lotion, Placebo control lotion
- Keywords
- melatonin, lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin sleep lotionOther
Also called Dr. Teal's Sleep Lotion
7 g of lotion applied to hands and arms one hour before bedtime
Placebo control lotionOther
Also called Dr. Teal's Lavender Essential Oils Lotion
7 g of lotion applied to hands and arms one hour before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Melatonin sleep lotion Night 1; Placebo control lotion Night 2 | Experimental | Participants in this arm received melatonin-containing "sleep lotion" to apply on the first night of saliva sampling. On the second night of saliva sampling, they received placebo control lotion. Receives: Other: Melatonin sleep lotion; Other: Placebo control lotion |
| Placebo control lotion Night 1; Melatonin sleep lotion Night 2 | Experimental | Participants in this arm received placebo control lotion to apply on the first night of saliva sampling. On the second night of saliva sampling, they received melatonin-containing "sleep lotion." Receives: Other: Melatonin sleep lotion; Other: Placebo control lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary melatonin
pg/ml of melatonin in saliva measured by enzyme-linked immunosorbent assay
Measured: Three samples over an hour: pre-lotion application (one hour before bedtime), 30 minutes after lotion application, and one hour after lotion application (at bedtime). This 1 hr sampling will happen on two separate nights within a week of enrollment.
Sleep Quality
Modified Pittsburgh Sleep Quality Index. Scores from 0 (good sleep quality) to 14 (poor sleep quality)
Measured: A 15 minute questionnaire taken each morning after lotion application and saliva sampling. These two mornings are both within a week of enrollment (specific dates chosen by participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start9 Feb 2022
- Primary completion8 Mar 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Participants will be randomized to either the melatonin lotion first or the placebo control lotion first, and then each participant will receive the other treatment second.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Redlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Olson, University of Redlands
- Investigators
- Lisa Olson, Ph.D., Principal investigator, University of Redlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053385
- Sponsor's protocol ID
- 2021-37-REDLANDS
- Status last verified
- Sep 2023
- First submitted
- 18 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized participant data will be provided upon request
Publications
Ponce C, Razon AD, Chao J, Nakagawa SK, Peterson MM, Roque AY, Vanderpool MA, Ferracane MJ, Olson LE. Impact of an over-the-counter "sleep lotion" on human salivary melatonin levels and sleep quality: a randomized controlled trial. Neuro Endocrinol Lett. 2024 Aug 12;45(3):167-172.
PubMed 39146562
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Commercial "Sleep Lotion" on Salivary Melatonin Levels and Sleep Quality in Undergraduates
- ClinicalTrials.gov ID
- NCT06053385
- Acronym / sponsor ID
- 2021-37-REDLANDS
- Conditions
- Sleep
- Keywords
- melatonin, lotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of RedlandsUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 25 Sep 2023 (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.
The goal of this clinical trial is to test an over-the-counter "sleep lotion" in healthy undergraduate college students. The main questions it aims to answer are:
- Does an over-the-counter "sleep lotion" containing melatonin actually increase melatonin levels in participants compared to a placebo (control) lotion?
- Does an over-the-counter "sleep lotion" containing melatonin improve the quality of participants' sleep compared to a placebo (control) lotion?
Participants will:
- provide three saliva samples on each of two nights
- apply melatonin-containing "sleep lotion" on one night and a placebo (control with no melatonin) lotion on the other night
- answer questionnaires about gender, race, ethnicity, medication use, exercise, and sleep quality
Detailed description
Melatonin is a hormone secreted by the pineal gland in the brain that regulates sleep. There are many over-the-counter products such as bubble baths, room sprays, and lotions that claim they contain melatonin and promote sleep. This study is a randomized, controlled, double-blind crossover trial to compare the impact of a commercial "sleep lotion" vs. a control lotion on melatonin levels detectable in saliva in healthy undergraduate students. Participants will provide saliva samples on two nights, one week apart, one hour before bedtime. The sample collections will take place just before and twice after applying 1) a melatonin lotion and 2) a placebo control lotion (order randomized). The investigators will determine whether the melatonin lotion affects the natural rise of melatonin before bedtime. A second dependent variable will be the quality of sleep on both nights. Potential confounding independent variables, such as gender, race, ethnicity, medication use, and exercise will also be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the melatonin lotion first or the placebo control lotion first, and then each participant will receive the other treatment second.
| Arm | Type | Receives |
|---|---|---|
| Melatonin sleep lotion Night 1; Placebo control lotion Night 2 | Experimental | Other: Melatonin sleep lotion, Other: Placebo control lotionParticipants in this arm received melatonin-containing "sleep lotion" to apply on the first night of saliva sampling. On the second night of saliva sampling, they received placebo control lotion. |
| Placebo control lotion Night 1; Melatonin sleep lotion Night 2 | Experimental | Other: Melatonin sleep lotion, Other: Placebo control lotionParticipants in this arm received placebo control lotion to apply on the first night of saliva sampling. On the second night of saliva sampling, they received melatonin-containing "sleep lotion." |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 24 years old
- current University of Redlands student
Key exclusion criteria (3 listed)
- Pregnancy
- currently taking any sleep medications
- allergies or sensitivities to scented lotion
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 |
|---|---|---|
| Melatonin sleep lotionAlso: Dr. Teal's Sleep Lotion7 g of lotion applied to hands and arms one hour before bedtime | Other | Melatonin sleep lotion Night 1; Placebo control lotion Night 2, Placebo control lotion Night 1; Melatonin sleep lotion Night 2 |
| Placebo control lotionAlso: Dr. Teal's Lavender Essential Oils Lotion7 g of lotion applied to hands and arms one hour before bedtime | Other | Melatonin sleep lotion Night 1; Placebo control lotion Night 2, Placebo control lotion Night 1; Melatonin sleep lotion Night 2 |
Primary outcome
Salivary melatonin
Time frame: Three samples over an hour: pre-lotion application (one hour before bedtime), 30 minutes after lotion application, and one hour after lotion application (at bedtime). This 1 hr sampling will happen on two separate nights within a week of enrollment.
pg/ml of melatonin in saliva measured by enzyme-linked immunosorbent assay
Sleep Quality
Time frame: A 15 minute questionnaire taken each morning after lotion application and saliva sampling. These two mornings are both within a week of enrollment (specific dates chosen by participant).
Modified Pittsburgh Sleep Quality Index. Scores from 0 (good sleep quality) to 14 (poor sleep quality)
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 28 Sep 2023.
- Derived from this study: PubMed 39146562Ponce C, Razon AD, Chao J, Nakagawa SK, Peterson MM, Roque AY, Vanderpool MA, Ferracane MJ, Olson LE. Impact of an over-the-counter "sleep lotion" on human salivary melatonin levels and sleep quality: a randomized controlled trial. Neuro Endocrinol Lett. 2024 Aug 12;45(3):167-172.
- Individual participant dataSharing planned: Yes. Anonymized participant data will be provided upon request
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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.
Lisa Olson, Ph.D. principal investigator
University of Redlands
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 sleep lotion in people with Sleep, run by University of Redlands at 1 site in United States.
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 2 inclusion and 3 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 28 Sep 2023. 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 States. 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. 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?
Salivary melatonin (time frame: Three samples over an hour: pre-lotion application (one hour before bedtime), 30 minutes after lotion application, and one hour after lotion application (at bedtime). This 1 hr sampling will happen on two separate nights within a week of enrollment.). 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?
On the ClinicalTrials.gov record for NCT06053385, which also lists 1 linked publication.
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 28 Sep 2023.