Clinical trial NCT06146712: A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
Official title: A Single-Group Study to Examine the Efficacy of a Melatonin Lotion With Magnesium to Improve Sleep Quality and Quantity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Asutra
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate the efficacy of Asutra's 'Dream the night away' nighttime lotion with melatonin and magnesium on sleep health in terms of quantity, quality, ease of falling asleep or falling back asleep after waking in the night, and grogginess upon waking. The study will be conducted as a virtual single-group trial in which all 35 participants will use the test product. This study will last 3 weeks, and participants will use the product daily (each night 30 minutes before bedtime for 20 nights). Participants will use a sleep tracker to monitor their sleep for a week at Baseline (before commencing the trial) and nightly throughout the trial. Participants will complete study-specific questionnaires at Baseline, and after first use, 3 days, 1 week, 2 weeks, and 3 weeks, in which they will also record the results from their sleep tracker.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-59.
* Must agree to not use any other sleep aids including prescriptions, supplements, or melatonin products during the study or 28 days prior to Baseline.
* Has favorable sleep conditions (a dark, quiet room to sleep in and is not woken up regularly throughout the night due to personal circumstances e.g. by a baby).
* Willing to maintain their standard sleep pattern and activity level for the duration of the study.
* Be generally healthy and not living with any uncontrolled chronic disease. Willing and able to supply and use their own sleep tracking device.

Exclusion Criteria:

* Diagnosed with any chronic sleep condition including insomnia, narcolepsy, or sleep apnea.
* Has extremely sensitive/irritable skin or diagnosed skin conditions.
* Has poor sleep hygiene as a result of specific personal circumstances e.g. new mothers.
* Women who are pregnant, breastfeeding, or attempting to become pregnant.
* Anyone unwilling or unable to follow the study protocol.
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Is currently undergoing, or planning to to undergo any sleep-related procedures in the next three weeks.
* A history of severe allergic reactions including but not limited to any of the product's ingredients.
* Heavy drinkers or drug users. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.

Primary outcomes:
measure: Changes in scores on the validated Sleep Quality Scale (SQS). [Timeline: Baseline to Week 3]
timeFrame: 3 weeks
measure: Changes in time asleep recorded by a wearable sleep tracker. [Timeline: Baseline to Week 3]
timeFrame: 3 weeks
measure: Changes in "sleep score" given by wearable sleep tracker. [Timeline: Baseline to Week 3]
timeFrame: 3 weeks
Secondary outcomes:
measure: Participants' perceptions of the product's efficacy. [Timeline: Baseline to Week 3]
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: