The Impact of Melatonin Lotion on Sleep and Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-21
SponsorUniversity of Redlands
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Crossover
Treatments tested in this trial
Melatonin lotion
Other intervention3 g lotion applied one hour before bedtime
Placebo lotion
Other intervention3 g of placebo lotion (scent-matched control) applied one hour before bedtime
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Melatonin lotion firstExperimental treatment 2 interventions
Group B: Placebo lotion firstExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Sleep disturbance
PROMIS SF v1.0 - Sleep Disturb 8b
Time frame
Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)2
Anxiety
PROMIS SF v1.0 - Anxiety 8a
Time frame
Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)3
Depression
PROMIS SF v1.0 - Depression 8b
Time frame
Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)4
Total sleep time
Measured via actigraphy
Time frame
Two weeks of data separated by a one week periodSecondary outcomes
1
Sleep-related impairment
PROMIS SF v1.0 - Sleep-Related Impairment 8a
Time frame
Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)2
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
Time frame
Two weeks of data separated by a one week period3
Salivary melatonin
For confirmation of protocol compliance
Time frame
Daily at bedtime for two weeks of data separated by a one week period4
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
Time frame
5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtimeSponsors and contacts
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Source ClinicalTrials.gov