Sleep, Circadian Rhythm & Skin Health

Sponsor
University Hospitals Cleveland Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02457000
Collaborator
(none)
59
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65.1
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Study Details

Study Description

Brief Summary

The purpose of this study is to explore the mechanisms behind how sleep quality may affect skin aging, skin integrity and skin disease.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    59 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Sleep, Circadian Rhythm & Skin Health
    Actual Study Start Date :
    Mar 1, 2015
    Actual Primary Completion Date :
    Aug 1, 2020
    Actual Study Completion Date :
    Aug 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Normal, healthy volunteers

    Normal, healthy volunteers without any skin pathology will be asked to undergo various procedures to evaluate their sleep and skin health.

    Volunteers with skin pathology

    Volunteers with skin pathology including but not limited to eczema, psoriasis, acne, and other inflammatory dermatoses will be asked to undergo various procedures to evaluate their sleep and skin health.

    Outcome Measures

    Primary Outcome Measures

    1. Analysis of Sleep Pattern via Actigraphy, Polysomnography & Questionnaires [7-14 days]

      The volunteers may be asked to wear a wrist actigraph to measure movement. This watch would be worn for 24 hours per day for 7-14 days. The volunteer may also be asked to fill out questionnaires regarding their sleep patterns. Note: Other methods of assessing sleep patterns may also be used including a portable polysomnogram or a standard, overnight sleep study.

    2. Evaluation of skin (both in terms of skin aging and skin disease) [Only once during the study or at specific time points depending on what other procedures are being performed]

      The volunteers may have their skin evaluated for skin aging using the SCINEXA tool. Volunteers with psoriasis may have their skin evaluated via PASI and/or PGA assessments. Volunteers may have photographs taken to compare clinical appearance with laboratory and research findings.

    Secondary Outcome Measures

    1. Sample Analysis (from skin, blood, urine, saliva and hair follicle samples) [Only once during the study or at specific time points depending on what other procedures are being performed]

      Skin, blood, urine, saliva and hair follicle samples may be collected from some volunteers to look at various markers related to sleep, the circadian rhythm and skin disease.

    2. Skin Barrier Recovery (via TEWL measurement) [Only once during the study or at specific time points depending on what other procedures are being performed]

      Skin barrier recovery via Transepidermal Water Loss (TEWL) measurement may be assessed in some volunteers.

    3. MED Testing & Recovery from UV-induced erythema [24 hours]

      MED Testing & Recovery from UV-induced erythema may be assessed in some volunteers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Males or females ages 18 years and above

    • Capable of giving informed consent

    • Adults who are either healthy, normal volunteers or those with a skin disease including but not limited to eczema, psoriasis, acne or other inflammatory dermatoses

    • Fitzpatrick Skin Type I-VI

    • In good general health

    • Willing to cooperate with study instructions

    Exclusion Criteria:
    • Volunteers 18 years or younger

    • Any serious medical or physical condition that would cause the subject significant discomfort with study procedures

    • Women who are pregnant, nursing, or who may become pregnant in the next 3 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44118

    Sponsors and Collaborators

    • University Hospitals Cleveland Medical Center

    Investigators

    • Principal Investigator: Kevin Cooper, MD, University Hospitals Cleveland Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Kevin Cooper, Principal Investigator, University Hospitals Cleveland Medical Center
    ClinicalTrials.gov Identifier:
    NCT02457000
    Other Study ID Numbers:
    • 12-14-23
    First Posted:
    May 29, 2015
    Last Update Posted:
    Dec 15, 2021
    Last Verified:
    Nov 1, 2021
    Keywords provided by Dr. Kevin Cooper, Principal Investigator, University Hospitals Cleveland Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 15, 2021