Sleep, Circadian Rhythm & Skin Health

November 30, 2021 updated by: Dr. Kevin Cooper, University Hospitals Cleveland Medical Center
The purpose of this study is to explore the mechanisms behind how sleep quality may affect skin aging, skin integrity and skin disease.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44118
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7-14 days
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.
Only once during the study or at specific time points depending on what other procedures are being performed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Only once during the study or at specific time points depending on what other procedures are being performed
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.
Only once during the study or at specific time points depending on what other procedures are being performed
MED Testing & Recovery from UV-induced erythema
Time Frame: 24 hours
MED Testing & Recovery from UV-induced erythema may be assessed in some volunteers.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Actual)

December 15, 2021

Last Update Submitted That Met QC Criteria

November 30, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-14-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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