Comprehensive Investigation of Heart Rate Variability as a Measure of the Autonomic Nervous System in Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gil Yosipovitch, Wake Forest University
ClinicalTrials.gov Identifier:
NCT00691366
First received: June 2, 2008
Last updated: August 8, 2012
Last verified: June 2008
  Purpose

The purpose of this research is to study heart rate patterns in people with moderate to severe atopic dermatitis and how itching affects those patterns.


Condition
Atopic Dermatitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Autonomic Nervous System Physiology and Chronic Pruritus: A Comprehensive Investigation of Heart Rate Variability as a Measure of the Autonomic Nervous System in Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Enrollment: 45
Study Start Date: March 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

To comprehensively evaluate the autonomic nervous system through heart rate variability (HRV) measurements in patients with moderate to severe atopic dermatitis suffering from pruritus.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Wake Forest University Health Sciences Dermatology Clinic population and from appropriate IRB-approved advertising in the community.

Criteria

Inclusion Criteria:

  • Adult men and women who are between 18 and 50 years of age.
  • Diagnosis of moderate to severe atopic dermatitis confirmed by published consensus diagnostic criteria26 (except for healthy control subjects). Severity will be based on an investigator's global assessment score and will have to be moderate or severe (IGA) (see Appendix 1).
  • Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation as determined by the investigators.
  • Women of child bearing potential will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, Norplant, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship. An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge.
  • Subjects must cease using topical agents on the forearm where experimental data is going to be collected at least 1 week prior. Topical agents can be used on all other parts of the body.
  • Subjects will be required to cease use of oral antihistamines for a period of one week prior to and during the study visit.

Exclusion Criteria:

  • Adults over age 50.
  • Children less than 18 years of age.
  • Unable to complete the required measures.
  • Diagnosis with other diseases that would affect the measurement of heart rate variability as determined by the investigators such as cardiovascular disease, hypertension, bradycardia (<60 beats per minute) and tachycardia (>100 beats per minute) amongst others.
  • Diagnosis with other skin diseases that would affect the measurement of transepidermal water loss (TEWL) and skin hydration as determined by the investigators.
  • Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and subjects undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation.
  • Consistent consumption of more than 4 caffeinated beverages per day.
  • Current treatment with oral lipophilic beta blockers, antihistamines, opioids, glucocorticoids, theophylline, anticholinergic medication or inhaled beta-agonists or anticholinergics or other medications known to interfere autonomic nervous system physiology.
  • Asthma/Chronic Obstructive Airways Disease or other respiratory disease.
  • Neuropathy causing diseases such as uremia.
  • Uncontrolled thyroid disease.
  • Diabetes mellitus.
  • Use of illicit drugs.
  • Current diagnosis of a psychiatric disorder27;28.
  • History of chronic urticaria.
  • History of anaphylactic shock.
  • Allergy to histamine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691366

Locations
United States, North Carolina
Facility: Wake Forest University Health Sciences Dermatology
Winston-Salem, North Carolina, United States, 27295
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Gil Yosipovitch, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Gil Yosipovitch, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT00691366     History of Changes
Other Study ID Numbers: 00002115
Study First Received: June 2, 2008
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014