The goal of this clinical trial is to learn whether regular use of Nizoral® Daily Prevent shampoo and conditioner can improve scalp comfort, sleep experiences, mood, and overall well-being in adults who have scalp discomfort and difficulty sleeping. The main questions it aims to answer are: 1. Does using the shampoo and conditioner improve scalp comfort and reduce the impact of scalp discomfort on daily life? 2. Does using the shampoo and conditioner improve sleep experiences and how rested participants feel? 3. Does using the shampoo and conditioner affect mood and other measures of well-being?. Participants completed a one-week period without hair products, followed by two weeks of using the study shampoo and conditioner at least three times per week. During the study, participants: 1. Attended weekly study visits. 2. Answered questions about their scalp comfort, sleep, and daily experiences. 3. Wore a wrist-based sleep tracking device throughout the study. Completed weekly questionnaires about sleep and scalp health. 4. Took part in non-invasive brain activity measurements during study visits.
This was a prospective, single-arm, observational study evaluating the effects of regular use of a cosmetic shampoo and conditioner on scalp comfort, sleep-related experiences, mood, and neurophysiological responses in adults reporting scalp discomfort and sleep difficulties. Participants were recruited from an internal volunteer database and screened against predefined eligibility criteria. All participants provided written informed consent before any study procedures. The study consisted of four weekly visits: a baseline visit (EEG, scalp and sleep questionnaires, initiation of Fitbit sleep monitoring), a washout visit one week later with no hair products, followed by two further visits assessing early and extended effects after approximately one and two weeks of product use, respectively. Daily sleep monitoring and weekly questionnaires continued throughout. EEG recordings were analyzed using Cognalyzer® EEG-based metrics, including mood valence, relaxation, sleepiness, anger, and mental arousal. The primary objective was to evaluate changes in neurophysiological and self-reported measures of scalp comfort, sleep experiences, mood, and well-being following product use; exploratory objectives included sleep-related outcomes and EEG-derived indicators of emotional and cognitive state.
Study Type
OBSERVATIONAL
Enrollment
21
Participants used the study cosmetic shampoo together with the study cosmetic conditioner at least three times per week for two consecutive weeks, following a one-week washout period without hair products.
Zentrela Inc.
Hamilton, Ontario, Canada
Change in EEG-Derived Mood Valence
EEG-derived mood valence, reflecting positive versus negative emotional state, compared between baseline visits (1-2) and product-use visits (3-4).
Time frame: Up to 4 weeks
Change in EEG-Derived Relaxation Level
EEG-derived relaxation level compared between baseline and product-use visits.
Time frame: Up to 4 weeks
Change in EEG-Derived Sleepiness Level
EEG-derived sleepiness indicators compared between baseline and product-use visits.
Time frame: Up to 4 weeks
Change in EEG-Derived Anger Level
EEG-derived anger-related response compared between baseline and product-use visits.
Time frame: Up to 4 weeks
Change in Self-Reported Scalp Comfort
Weekly questionnaire measures of scalp itch and discomfort compared between baseline and product-use periods.
Time frame: Up to 4 weeks
Change in Self-Reported Sleep Quality
Weekly questionnaire measures of sleep onset, night-time waking, and feeling rested, compared between baseline and product-use periods.
Time frame: Up to 4 weeks
Change in Fitbit-Measured Sleep Parameters
Wearable-derived sleep metrics collected nightly, compared between baseline and product-use periods.
Time frame: Up to 4 weeks
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