Melatonin Lotion for Sleep Disorders
Recruiting in Palo Alto (17 mi)
Overseen ByLisa E Olson, Ph.D.
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Redlands
Must not be taking: Antidepressants, Anti-anxiety, Sleep meds
Disqualifiers: Pregnancy, Lotion allergies, others
No Placebo Group
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any antidepressant, anti-anxiety, or sleep medications, including melatonin, to participate in this trial.
What data supports the effectiveness of the treatment Melatonin Lotion for sleep disorders?
Research shows that melatonin, when delivered through the skin (transdermal), can help improve sleep by reducing waking after sleep onset and promoting sleep during challenging times, like daytime for shift workers. This suggests that melatonin lotion might be effective for sleep disorders by maintaining sleep better than oral forms.
12345Is melatonin lotion safe for humans?
Melatonin is generally considered safe for short-term use, but there are concerns about potential risks, especially with long-term use, in certain groups like children and people with epilepsy or asthma.
678910How does melatonin lotion differ from other sleep disorder treatments?
Melatonin lotion offers a unique transdermal (through the skin) delivery method, which may provide more consistent melatonin levels and improve sleep maintenance compared to fast-release oral melatonin, especially during adverse circadian phases like shift work or jet lag.
134511Eligibility Criteria
This trial is for young adults with sleep issues and mild symptoms of depression or anxiety. Participants must have specific scores on the PROMIS measures for sleep disturbance, anxiety, or depression to join.Inclusion Criteria
My sleep disturbance score is 48 or higher.
T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)
Exclusion Criteria
I am currently taking medication for depression, anxiety, or sleep issues.
Pregnancy
Allergies/sensitivities to scented lotion
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive melatonin lotion or placebo lotion in a randomized crossover design for one week each, with a one-week washout period in between
3 weeks
3 visits (in-person) for equipment and sample return
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if melatonin lotion improves sleep quality and mental health in young adults. It involves comparing a placebo lotion (no active ingredient) with a melatonin-infused lotion over separate weeks, using surveys, actigraphs, heart rate monitors, and saliva samples.
2Treatment groups
Experimental Treatment
Group I: Placebo lotion firstExperimental Treatment2 Interventions
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
Group II: Melatonin lotion firstExperimental Treatment2 Interventions
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of RedlandsRedlands, CA
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Who Is Running the Clinical Trial?
University of RedlandsLead Sponsor
References
[Melatonin: is there a rationale for the clinical use of this hormone in sleep therapy?]. [2015]Melatonin, the hormone of the pineal gland, is under discussion as multipotent hormone for different indications. The question whether there is a therapeutical benefit for all these indications could not be evaluated, because more clinical studies are needed. Based on the data of basic research as well as first clinical experience, the use of melatonin to treat sleep disorders caused by a deficit of melatonin might be appropriate. Other indications, derived from animal studies where the results often could not be applied to humans, have still to be proved. Given the fact that melatonin is not an approved product, only an intent to treat approach is allowed where it might by useful to document the melatonin deficit and to use a selected and certificate product.
Sleep-promoting effects of melatonin: at what dose, in whom, under what conditions, and by what mechanisms? [2022]Differing conclusions regarding the sleep-promoting effects of melatonin may be the result of the broad range of doses employed (0.1-2000 mg), the differing categories of subjects tested (normal subjects, insomniac patients, elderly, etc.), and the varying times of administration (for daytime vs. nighttime sleep). We conclude that melatonin may benefit sleep by correcting circadian phase abnormalities and/or by a modest direct soporific effect that is most evident following daytime administration to younger subjects. We speculate that these effects are mediated by interactions with specific receptors concentrated in the suprachiasmatic nucleus (SCN) that result in resetting of the circadian pacemaker and/or attenuation of an SCN-dependent circadian alerting process.
Meta-analysis: melatonin for the treatment of primary sleep disorders. [2021]To investigate the efficacy of melatonin compared to placebo in improving sleep parameters in patients with primary sleep disorders.
Use of transdermal melatonin delivery to improve sleep maintenance during daytime. [2021]Oral melatonin (MEL) can improve daytime sleep, but the hormone's short elimination half-life limits its use as a hypnotic in shift workers and individuals with jet lag or other sleep problems. Here we show, in healthy subjects, that transdermal delivery of MEL during the daytime can elevate plasma MEL and reduce waking after sleep onset, by promoting sleep in the latter part of an 8-h sleep opportunity. Transdermal MEL may have advantages over fast-release oral MEL in improving sleep maintenance during adverse circadian phases.
Use of melatonin in the treatment of phase shift and sleep disorders. [2019]When administered to humans the pineal hormone melatonin can phase shift a number of circadian rhythms. This property has prompted the investigation of exogenous melatonin in sleep disorders known to have an underlying chronophysiological basis (i.e. circadian rhythm sleep disorders). Both in field and simulated studies of jet lag and shift work suitably timed melatonin improved sleep and, in some cases, hastened readaptation of the circadian rhythms following the phase shift. Melatonin treatment has also been evaluated in the circadian sleep disorders: delayed sleep phase syndrome (DSPS) and non-24-hour sleep wake disorder. Compared with placebo, melatonin advanced the sleep period in subjects with DSPS. Melatonin also improved a number of sleep parameters in blind subjects suffering from non-24-hour sleep wake disorder.
Adverse Events Associated with Melatonin for the Treatment of Primary or Secondary Sleep Disorders: A Systematic Review. [2020]Melatonin is widely available either on prescription for the treatment of sleep disorders or as an over-the-counter dietary supplement. Melatonin has also recently been licensed in the UK for the short-term treatment of jetlag. Little is known about the potential for adverse events (AEs), in particular AEs resulting from long-term use. Concern has been raised over the possible risks of exposure in certain populations including pre-adolescent children and patients with epilepsy or asthma.
Antiaging efficacy of melatonin-based day and night creams: a randomized, split-face, assessor-blinded proof-of-concept trial. [2022]Skin is a complete and independent melatoninergic system. At the skin level, melatonin (Mel) acts as a relevant antioxidant and cytoprotective substance. Topical application of Mel is considered meaningful, since it can easily penetrate the stratum corneum. Exogenous Mel can be expected to represent a potent antioxidative defense system against skin aging mechanisms. Day and night creams containing Mel, carried in lipospheres (Melatosphere™), have been developed (Nutriage SPF 30 day cream and Nutriage night cream).
Melatonin Delivery: Transdermal and Transbuccal Evaluation in Different Vehicles. [2018]Melatonin (MLT) could be candidate drug for treatment of several diseases because of its high antioxidant and anticarcinogenic activity and its important biological roles. The aim of this study was to assess the influence of different vehicles on the permeation of MLT through buccal and skin tissues.
Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis. [2018]To conduct a systematic review of the efficacy and safety of exogenous melatonin in managing secondary sleep disorders and sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder.
The short-term and long-term adverse effects of melatonin treatment in children and adolescents: a systematic review and GRADE assessment. [2023]Currently, melatonin is used to treat children and adolescents with insomnia without knowing the full extent of the short-term and long-term consequences. Our aim was to provide clinicians and guideline panels with a systematic assessment of serious-and non-serious adverse events seen in continuation of melatonin treatment and the impact on pubertal development and bone health following long-term administration in children and adolescents with chronic insomnia.
Therapeutic potential of melatonin agonists. [2019]Melatonin, a hormone secreted by the pineal gland, has been successfully employed to improve sleep in both normal patients and insomniacs, and for the treatment of circadian rhythm sleep disorders. Melatonergic MT1 and MT2 receptors exist in high concentrations in the suprachiasmatic nucleus of the hypothalamus and have been shown to be instrumental for the sleep-promoting and circadian rhythm-regulating effects of melatonin. A lack of consistency among reports on the therapeutic efficacy of melatonin has been attributed to differences in melatonin's bioavailability and the short half-life of the hormone. In view of the need for longer acting melatonergic agonists that improve sleep efficiency without causing drug abuse or dependency, ramelteon (Rozerem™, Takeda) was developed. Ramelteon, which acts via MT1/MT2 melatonergic agonism, has been found clinically effective for improving total sleep time and sleep efficiency in insomniacs. Agomelatine (Valdoxan™, Servier) is another MT1/MT2 melatonergic agonist that also displays antagonist activity at 5-HT2C serotonin receptors. Agomelatine has been found effective in treating depression and sleep disorders in patients with major depressive disorder. A slow-release preparation of melatonin (Circadin™, Neurim) has been shown to be effective in treating sleep disorders in the elderly population.