Neurophysiological, Sleep-Related, and Mood Effects of a Cosmetic Shampoo and Conditioner Regimen in Adults With Scalp Discomfort and Sleep Difficulty: A Pilot EEG-Based Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in EEG-Derived Mood Valence
研究概览
简要总结
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:
- Does using the shampoo and conditioner improve scalp comfort and reduce the impact of scalp discomfort on daily life?
- Does using the shampoo and conditioner improve sleep experiences and how rested participants feel?
- 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:
- Attended weekly study visits.
- Answered questions about their scalp comfort, sleep, and daily experiences.
- Wore a wrist-based sleep tracking device throughout the study. Completed weekly questionnaires about sleep and scalp health.
- Took part in non-invasive brain activity measurements during study visits.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Reported at least one scalp symptom within the past 2 weeks, such as itching, dryness, sensitivity, redness, or flakes.
- •Experienced scalp discomfort occasionally or more often during the past 2 weeks.
- •Reported a scalp discomfort rating of 4 or higher on a 0-10 scale.
- •Reported difficulty falling asleep or staying asleep within the past 2 weeks.
- •Experienced sleep difficulty more than once per week.
- •Willing and able to use the study shampoo and conditioner at least 3 times per week during the study.
- •Willing and able to wear a Fitbit sleep-tracking device during the study.
- •Able to attend all scheduled study visits.
- •Able to provide informed consent.
排除标准
- •Current use of medicated scalp treatments or use within the previous 14 days.
- •Known allergy or sensitivity to ingredients commonly found in shampoos or conditioners.
- •Ongoing scalp conditions, including active psoriasis, eczema, or open sores.
- •Use of sleep aids, sedatives, antihistamines, or other medications that affect sleep more than once per week during the previous 2 weeks.
- •Participation in another clinical, cosmetic, or consumer research study within the previous 30 days.
- •Any condition that, in the opinion of the investigators, could interfere with study participation, compliance with study procedures, or interpretation of study results.
研究组 & 干预措施
Dandruff Group
干预措施: Cosmetic Shampoo and Conditioner Regimen (Other)
结局指标
主要结局
Change in EEG-Derived Mood Valence
时间窗: Up to 4 weeks
EEG-derived mood valence, reflecting positive versus negative emotional state, compared between baseline visits (1-2) and product-use visits (3-4).
次要结局
- Change in EEG-Derived Relaxation Level(Up to 4 weeks)
- Change in EEG-Derived Sleepiness Level(Up to 4 weeks)
- Change in EEG-Derived Anger Level(Up to 4 weeks)
- Change in Self-Reported Scalp Comfort(Up to 4 weeks)
- Change in Self-Reported Sleep Quality(Up to 4 weeks)
- Change in Fitbit-Measured Sleep Parameters(Up to 4 weeks)