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CompletedNCT07680608Updated Jul 6, 2026

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

An observational study in Dandruff, sponsored by Zentrela Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Zentrela Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study summary

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.
Read the detailed description

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.

02

Conditions studied

  • Dandruff

Keywords

  • dandruff
  • EEG
  • well-being
  • machine learning
03

In context

Lead sponsor

Zentrela Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
21 participants (actual)
Patient registry
No

Groups and cohorts

  • Dandruff Group

    Other: Cosmetic Shampoo and Conditioner Regimen

Interventions

  • OtherCosmetic 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in EEG-Derived Relaxation Level

    EEG-derived relaxation level compared between baseline and product-use visits.

    Time frame: Up to 4 weeks

  2. Change in EEG-Derived Sleepiness Level

    EEG-derived sleepiness indicators compared between baseline and product-use visits.

    Time frame: Up to 4 weeks

  3. Change in EEG-Derived Anger Level

    EEG-derived anger-related response compared between baseline and product-use visits.

    Time frame: Up to 4 weeks

  4. 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

  5. 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

  6. 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

07

Study locations

1 site
  • Zentrela Inc.
    Hamilton, Ontario L8P 1J4, Canada
08

References and documents

Publications

  • 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. PubMed 34727345 ↗
  • 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. PubMed 33826089 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07680608
Lead sponsor
Zentrela Inc.
Collaborators
Thornton & Ross
Responsible party
Sponsor
First posted
Jul 2, 2026
Start date
Nov 7, 2025
Primary completion
Feb 7, 2026
Completion
Feb 7, 2026
Last update
Jul 6, 2026

Study contacts

Dan Bosnyak, PhD
principal investigator · McMaster University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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