Neurophysiological and Sleep-Related Effects of a Cosmetic Shampoo and Conditioner in Adults With Scalp Discomfort
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
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Ontario
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Hamilton, Ontario, Kanada, L8P 1J4
- Zentrela Inc.
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Dandruff Group
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in EEG-Derived Mood Valence
Časové okno: 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).
|
Up to 4 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in EEG-Derived Relaxation Level
Časové okno: Up to 4 weeks
|
EEG-derived relaxation level compared between baseline and product-use visits.
|
Up to 4 weeks
|
|
Change in EEG-Derived Sleepiness Level
Časové okno: Up to 4 weeks
|
EEG-derived sleepiness indicators compared between baseline and product-use visits.
|
Up to 4 weeks
|
|
Change in EEG-Derived Anger Level
Časové okno: Up to 4 weeks
|
EEG-derived anger-related response compared between baseline and product-use visits.
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Up to 4 weeks
|
|
Change in Self-Reported Scalp Comfort
Časové okno: Up to 4 weeks
|
Weekly questionnaire measures of scalp itch and discomfort compared between baseline and product-use periods.
|
Up to 4 weeks
|
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Change in Self-Reported Sleep Quality
Časové okno: Up to 4 weeks
|
Weekly questionnaire measures of sleep onset, night-time waking, and feeling rested, compared between baseline and product-use periods.
|
Up to 4 weeks
|
|
Change in Fitbit-Measured Sleep Parameters
Časové okno: Up to 4 weeks
|
Wearable-derived sleep metrics collected nightly, compared between baseline and product-use periods.
|
Up to 4 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Dan Bosnyak, PhD, McMaster University
Publikace a užitečné odkazy
Obecné publikace
- Bosnyak D, McDonald AC, Gasperin Haaz I, Qi W, Crowley DC, Guthrie N, Evans M. Use of a Novel EEG-Based Objective Test, the Cognalyzer(R), in Quantifying the Strength and Determining the Action Time of Cannabis Psychoactive Effects and Factors that May Influence Them Within an Observational Study Framework. Neurol Ther. 2022 Mar;11(1):51-72. doi: 10.1007/s40120-021-00293-w. Epub 2021 Nov 2.
- McDonald AC, Gasperin Haaz I, Qi W, Crowley DC, Guthrie N, Evans M, Bosnyak D. Sensitivity, Specificity and Accuracy of a Novel EEG-Based Objective Test, the Cognalyzer(R), in Detecting Cannabis Psychoactive Effects. Adv Ther. 2021 May;38(5):2513-2531. doi: 10.1007/s12325-021-01718-6. Epub 2021 Apr 7.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CUSIC-74
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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