The Impact of Melatonin Lotion on Sleep and Mental Health

Официальное название

The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Melatonin lotion
  3 g lotion applied one hour before bedtime
• Другое Placebo lotion
  3 g of placebo lotion (scent-matched control) applied one hour before bedtime

Первичные конечные точки

• Sleep disturbance [Срок оценки: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)]
• Anxiety [Срок оценки: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)]
• Depression [Срок оценки: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)]
• Total sleep time [Срок оценки: Two weeks of data separated by a one week period]
• Sleep efficiency [Срок оценки: Two weeks of data separated by a one week period]
• Normalized high frequency power of heart rate variability [Срок оценки: Two weeks of data separated by a one week period]
• Anxiety by momentary ecological assessment [Срок оценки: Three times per day for two weeks of data separated by a one week period]
• Mood by momentary ecological assessment [Срок оценки: Three times per day for two weeks of data separated by a one week period]
• Salivary alpha-amylase [Срок оценки: Daily at bedtime for two weeks of data separated by a one week period]

Вторичные конечные точки (5)

• Sleep-related impairment [Срок оценки: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total)]
• Other sleep variables [Срок оценки: Two weeks of data separated by a one week period]
• Salivary melatonin [Срок оценки: Daily at bedtime for two weeks of data separated by a one week period]
• Other HRV variables [Срок оценки: 5 min period sitting upright each morning after waking, and overnight data capture starting one hour before bedtime]
• Side effects [Срок оценки: Daily for two weeks of data separated by a one week period]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Redlands — Redlands

Идентификаторы

NCT: NCT06768749 · 2024-032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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