Sleep, Circadian Rhythm & Skin Health

Completed

• Conditions: Acne; Healthy; Psoriasis; Eczema

• Registration Number: NCT02457000
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-29
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
MED Testing & Recovery from UV-induced erythema	24 hours	MED Testing \& Recovery from UV-induced erythema may be assessed in some volunteers.
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.
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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States