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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Ontario
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Hamilton, Ontario, Kanada, L8P 1J4
- Zentrela Inc.
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in EEG-Derived Mood Valence
Zeitfenster: 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).
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Up to 4 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in EEG-Derived Relaxation Level
Zeitfenster: 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
Zeitfenster: Up to 4 weeks
|
EEG-derived sleepiness indicators compared between baseline and product-use visits.
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Up to 4 weeks
|
|
Change in EEG-Derived Anger Level
Zeitfenster: 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
Zeitfenster: Up to 4 weeks
|
Weekly questionnaire measures of scalp itch and discomfort compared between baseline and product-use periods.
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Up to 4 weeks
|
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Change in Self-Reported Sleep Quality
Zeitfenster: Up to 4 weeks
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Weekly questionnaire measures of sleep onset, night-time waking, and feeling rested, compared between baseline and product-use periods.
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Up to 4 weeks
|
|
Change in Fitbit-Measured Sleep Parameters
Zeitfenster: Up to 4 weeks
|
Wearable-derived sleep metrics collected nightly, compared between baseline and product-use periods.
|
Up to 4 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Dan Bosnyak, PhD, McMaster University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CUSIC-74
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