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Sleep, Circadian Rhythm & Skin Health

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ClinicalTrials.gov Identifier: NCT02457000
Recruitment Status : Recruiting
First Posted : May 29, 2015
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
Elma D. Baron, University Hospitals Cleveland Medical Center

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
Healthy Psoriasis Eczema Acne

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Official Title: Sleep, Circadian Rhythm & Skin Health
Study Start Date : March 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Analysis of Sleep Pattern via Actigraphy, Polysomnography & Questionnaires [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 24 hours ]
    MED Testing & Recovery from UV-induced erythema may be assessed in some volunteers.


Biospecimen Retention:   Samples Without DNA
Skin, blood, urine, saliva and hair follicle samples may be collected from volunteers to look at various markers related to sleep, the circadian rhythm and skin disease.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults from Northeast Ohio who are either healthy, normal volunteers or have skin pathology including but not limited to eczema, psoriasis, acne, and other inflammatory dermatoses
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457000


Contacts
Contact: A'ja Patterson 216-844-7546 aja.patterson@uhhospitals.org
Contact: Mary Consolo, BS 216-844-7546 mary.consolo@uhhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44118
Contact: Mary Consolo, BS    216-844-7546    mary.consolo@uhhospitals.org   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Elma Baron, MD University Hospitals Cleveland Medical Center