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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
35
Product contains Water (Aqua), Magnesium Chloride, Dimethyl Sulfone (MSM), Prunus Amygdalus Dulcis (Sweet Almond) Oil, Butyrospermum Parkii (Shea Butter), Sodium Lactate, Cetearyl Alcohol, Glyceryl Stearate Citrate, Glycerin, Undecane, Cetyl Palmitate, Polyglyceryl-3 Diisostearate, Pentylene Glycol, Glyceryl Stearate, Magnesium Sulfate, Melatonin, Tridecane, Potassium Chloride, Sodium Chloride, Calcium Chloride, Tocopheryl Acetate, Xanthan Gum, Hydroxyacetophenone, Sodium Hydroxide, Cymbopogon Flexuosus (East-Indian Lemongrass) Oil, Citral, Geraniol, Linalool
Citruslabs
Santa Monica, California, United States
Changes in scores on the validated Sleep Quality Scale (SQS). [Timeline: Baseline to Week 3]
Consisting of 28 items, the SQS evaluates six domains of sleep quality: daytime symptoms, restoration after sleep, problems initiating. Using a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "some- times," 2 = "often," and 3 = "almost always").
Time frame: 3 weeks
Changes in time asleep recorded by a wearable sleep tracker. [Timeline: Baseline to Week 3]
The total time asleep every night will be recorded using a wearable sleep tracker, the Fitbit Inspire 3.
Time frame: 3 weeks
Changes in "sleep score" given by wearable sleep tracker. [Timeline: Baseline to Week 3]
The Fitbit Inspire 3 gives a nightly "sleep score". This is based on heart rate, the time spent awake or restless, and the sleep stages. The score is out of 100, with 100 being the best possible score.
Time frame: 3 weeks
Participants' perceptions of the product's efficacy. [Timeline: Baseline to Week 3]
Participants' perception of the product's efficacy in improving sleep quality will be assessed via study-specific questionnaire. Participants will respond to Likert-scale questions (0-4 point scale) with 0=the least favourable score and 4=the most favourable score.
Time frame: 3 weeks
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