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Neurophysiological and Sleep-Related Effects of a Cosmetic Shampoo and Conditioner in Adults With Scalp Discomfort

2. juli 2026 opdateret af: Zentrela Inc.

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:

  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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

21

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8P 1J4
        • Zentrela Inc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants were recruited from an existing volunteer database maintained by the research site in Hamilton, Ontario, Canada. The study population consisted of community-dwelling adults interested in participating in consumer product research. Recruitment was conducted through database outreach and screening questionnaires. Participants were selected from the local community and represented a range of ages and both sexes.

Beskrivelse

Inclusion Criteria:

  1. Age 18 years or older.
  2. Reported at least one scalp symptom within the past 2 weeks, such as itching, dryness, sensitivity, redness, or flakes.
  3. Experienced scalp discomfort occasionally or more often during the past 2 weeks.
  4. Reported a scalp discomfort rating of 4 or higher on a 0-10 scale.
  5. Reported difficulty falling asleep or staying asleep within the past 2 weeks.
  6. Experienced sleep difficulty more than once per week.
  7. Willing and able to use the study shampoo and conditioner at least 3 times per week during the study.
  8. Willing and able to wear a Fitbit sleep-tracking device during the study.
  9. Able to attend all scheduled study visits.
  10. Able to provide informed consent.

Exclusion Criteria:

  1. Current use of medicated scalp treatments or use within the previous 14 days.
  2. Known allergy or sensitivity to ingredients commonly found in shampoos or conditioners.
  3. Ongoing scalp conditions, including active psoriasis, eczema, or open sores.
  4. Use of sleep aids, sedatives, antihistamines, or other medications that affect sleep more than once per week during the previous 2 weeks.
  5. Participation in another clinical, cosmetic, or consumer research study within the previous 30 days.
  6. Any condition that, in the opinion of the investigators, could interfere with study participation, compliance with study procedures, or interpretation of study results.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Dandruff Group
Andet: Cosmetic Shampoo and Conditioner Regimen
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in EEG-Derived Mood Valence
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in EEG-Derived Relaxation Level
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 4 weeks
EEG-derived anger-related response compared between baseline and product-use visits.
Up to 4 weeks
Change in Self-Reported Scalp Comfort
Tidsramme: Up to 4 weeks
Weekly questionnaire measures of scalp itch and discomfort compared between baseline and product-use periods.
Up to 4 weeks
Change in Self-Reported Sleep Quality
Tidsramme: 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
Tidsramme: Up to 4 weeks
Wearable-derived sleep metrics collected nightly, compared between baseline and product-use periods.
Up to 4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zentrela Inc.

Samarbejdspartnere

Thornton & Ross

Efterforskere

  • Ledende efterforsker: Dan Bosnyak, PhD, McMaster University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. november 2025

Primær færdiggørelse (Faktiske)

7. februar 2026

Studieafslutning (Faktiske)

7. februar 2026

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CUSIC-74

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data collected during this study, including electroencephalography (EEG), questionnaire, and wearable device data, will not be made available to other researchers. The study was conducted as a sponsor-supported consumer product research study, and there is no plan to share de-identified participant-level datasets or supporting data dictionaries outside the study team.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Cosmetic Shampoo and Conditioner Regimen

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Indonesia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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