Sleep ProblemsNCT06768749
The Impact of Melatonin Lotion on Sleep and Mental Health
A study testing Melatonin lotion in people with Sleep Problems and Depressive Disorder and Anxiety Disorders, run by University of Redlands at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. Read more about this study
- Who is it for?
- Ages 18 to 21 years
- Conditions the study is for
- Sleep Problems, Depressive Disorder and Anxiety Disorders
- What is being tested?
- Melatonin lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and
- a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)
Who cannot join
- currently using antidepressant, anti-anxiety, or sleep medication including melatonin
- are pregnant
- have allergies/sensitivities to scented lotion
- are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Redlands
Redlands, California, 92374
Lisa Olson, Ph.D., 909-748-8524, lisa_olson@redlands.edu
Lisa Olson, Ph.D.
About this study
Official title: The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects
The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.
Read the detailed description
All participants will receive a melatonin lotion and a placebo lotion in a randomized crossover design. Participants will receive equipment and supplies on a Monday and will begin the assigned treatment that night, by self-applying premeasured lotion 1 hour before bedtime. During the two treatment weeks, participants will wear ActiGraph GT3X-BT accelerometers (ActiGraph, Pensacola, FL) at all times except when bathing or submerged in water. They will wear Polar H10 heart rate monitor chest straps (Polar Electro, Kempele, Finland) from one hour prior to bedtime until after a 5 min sitting period after waking. Three times daily they will be asked 1-item mood/anxiety questions ("How ___ do you feel right now?") through REDCap software. Participants will check any experienced side effects off a checklist once daily. Participants will collect a passive drool sample daily at bedtime and store in their home freezer until returning the samples to the laboratory. Treatment will occur for seven nights, with a return of equipment and saliva samples as well as confirmation of actigraphy and HRV readings the following Monday. After a seven day washout period to reduce any carryover effects, equipment and supplies will be supplied the next Monday and the participant will begin the other assigned treatment (active or placebo) that night in a crossover design. At three timepoints (pre-treatment, at the end of the melatonin treatment week, and at the end of the placebo week), participants will answer the following surveys online via REDCap: PROMIS short forms for anxiety, depression, sleep quality, and sleep-related impairment.
- Being tested
- Melatonin lotion, Placebo lotion
- Keywords
- melatonin, sleep, heart rate variability, actigraphy, amylase, mood, anxiety, depression
- Medical subject headings
- Parasomnias, Depressive Disorder, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin lotionOther
3 g lotion applied one hour before bedtime
Placebo lotionOther
3 g of placebo lotion (scent-matched control) applied one hour before bedtime
| Study group | Role | What they receive |
|---|---|---|
| Melatonin lotion first | Experimental | Participants will be randomized to one week of treatment with melatonin lotion, followed by a week washout, then one week of treatment with placebo lotion Receives: Other: Melatonin lotion; Other: Placebo lotion |
| Placebo lotion first | Experimental | Participants will be randomized to one week of treatment with placebo lotion, followed by a week washout, then one week of treatment with melatonin lotion Receives: Other: Melatonin lotion; Other: Placebo lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disturbance
PROMIS SF v1.0 - Sleep Disturb 8b
Measured: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Anxiety
PROMIS SF v1.0 - Anxiety 8a
Measured: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Depression
PROMIS SF v1.0 - Depression 8b
Measured: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Total sleep time
Measured via actigraphy
Measured: Two weeks of data separated by a one week period
Sleep efficiency
Measured by actigraphy
Measured: Two weeks of data separated by a one week period
Normalized high frequency power of heart rate variability
5 min period during sleep latency, overnight recording while sleeping, and 5 min period sitting upright each morning
Measured: Two weeks of data separated by a one week period
Anxiety by momentary ecological assessment
One item question: "How anxious do you feel right now?"
Measured: Three times per day for two weeks of data separated by a one week period
Mood by momentary ecological assessment
Single-item questions ("How ___ do you feel right now?)
Measured: Three times per day for two weeks of data separated by a one week period
Salivary alpha-amylase
As an indicator of sympathetic nervous system activity
Measured: Daily at bedtime for two weeks of data separated by a one week period
Secondary outcomes (5)
Sleep-related impairment
PROMIS SF v1.0 - Sleep-Related Impairment 8a
Measured: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Other sleep variables
A MANOVA will be conducted with the primary sleep outcomes as well as sleep onset latency (both self-reported and as measured by actigraphy) and subjective sleep quality
Measured: Two weeks of data separated by a one week period
Salivary melatonin
For confirmation of protocol compliance
Measured: Daily at bedtime for two weeks of data separated by a one week period
Other HRV variables
A MANOVA will be conducted with autonomic nervous system indicators including normalized high frequency HRV and salivary alpha amylase as primary outcomes, but also including LF/HF ratio, RMSSD, and pNN50
Measured: 5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime
Side effects
Frequency of headache, drowsiness, skin irritation, vivid dreams, nightmares, dizziness, and other
Measured: Daily for two weeks of data separated by a one week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start28 Feb 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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 E Olson, Ph.D., Principal investigator, University of Redlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768749
- Sponsor's protocol ID
- 2024-032
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD (deidentified through the safe harbor method)
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects
- ClinicalTrials.gov ID
- NCT06768749
- Acronym / sponsor ID
- 2024-032
- Keywords
- melatonin, sleep, heart rate variability, actigraphy, amylase, mood, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RedlandsUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 10 Jan 2025 (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 purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.
Detailed description
All participants will receive a melatonin lotion and a placebo lotion in a randomized crossover design. Participants will receive equipment and supplies on a Monday and will begin the assigned treatment that night, by self-applying premeasured lotion 1 hour before bedtime. During the two treatment weeks, participants will wear ActiGraph GT3X-BT accelerometers (ActiGraph, Pensacola, FL) at all times except when bathing or submerged in water. They will wear Polar H10 heart rate monitor chest straps (Polar Electro, Kempele, Finland) from one hour prior to bedtime until after a 5 min sitting period after waking. Three times daily they will be asked 1-item mood/anxiety questions ("How ___ do you feel right now?") through REDCap software. Participants will check any experienced side effects off a checklist once daily. Participants will collect a passive drool sample daily at bedtime and store in their home freezer until returning the samples to the laboratory. Treatment will occur for seven nights, with a return of equipment and saliva samples as well as confirmation of actigraphy and HRV readings the following Monday. After a seven day washout period to reduce any carryover effects, equipment and supplies will be supplied the next Monday and the participant will begin the other assigned treatment (active or placebo) that night in a crossover design. At three timepoints (pre-treatment, at the end of the melatonin treatment week, and at the end of the placebo week), participants will answer the following surveys online via REDCap: PROMIS short forms for anxiety, depression, sleep quality, and sleep-related impairment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin lotion first | Experimental | Other: Melatonin lotion, Other: Placebo lotionParticipants will be randomized to one week of treatment with melatonin lotion, followed by a week washout, then one week of treatment with placebo lotion |
| Placebo lotion first | Experimental | Other: Melatonin lotion, Other: Placebo lotionParticipants will be randomized to one week of treatment with placebo lotion, followed by a week washout, then one week of treatment with melatonin lotion |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and
- a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)
Key exclusion criteria (4 listed)
- currently using antidepressant, anti-anxiety, or sleep medication including melatonin
- are pregnant
- have allergies/sensitivities to scented lotion
- are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.
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 lotion3 g lotion applied one hour before bedtime | Other | Melatonin lotion first, Placebo lotion first |
| Placebo lotion3 g of placebo lotion (scent-matched control) applied one hour before bedtime | Other | Melatonin lotion first, Placebo lotion first |
Primary outcome
Sleep disturbance
Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
PROMIS SF v1.0 - Sleep Disturb 8b
Anxiety
Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
PROMIS SF v1.0 - Anxiety 8a
Depression
Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
PROMIS SF v1.0 - Depression 8b
Total sleep time
Time frame: Two weeks of data separated by a one week period
Measured via actigraphy
Sleep efficiency
Time frame: Two weeks of data separated by a one week period
Measured by actigraphy
Normalized high frequency power of heart rate variability
Time frame: Two weeks of data separated by a one week period
5 min period during sleep latency, overnight recording while sleeping, and 5 min period sitting upright each morning
Anxiety by momentary ecological assessment
Time frame: Three times per day for two weeks of data separated by a one week period
One item question: "How anxious do you feel right now?"
Mood by momentary ecological assessment
Time frame: Three times per day for two weeks of data separated by a one week period
Single-item questions ("How ___ do you feel right now?)
Salivary alpha-amylase
Time frame: Daily at bedtime for two weeks of data separated by a one week period
As an indicator of sympathetic nervous system activity
5 secondary outcomes
Sleep-related impairment
Time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)
Other sleep variables
Time frame: Two weeks of data separated by a one week period
Salivary melatonin
Time frame: Daily at bedtime for two weeks of data separated by a one week period
Other HRV variables
Time frame: 5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime
Side effects
Time frame: Daily for two weeks of data separated by a one week period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. All IPD (deidentified through the safe harbor method)
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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.
Lisa E 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 lotion in people with Sleep Problems and Depressive Disorder and Anxiety Disorders, 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 4 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa E Olson, Ph.D. (909-748-8524, lisa_olson@redlands.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disturbance (time frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)). The study lists 9 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 1 May 2026.