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Autism Spectrum Disorder (ASD) Fever Effect Pilot Study Completed
SAN DIEGO, Nov. 18, 2019 /PRNewswire/ -- AVACEN Medical, Inc. (AVACEN) announced that its sponsored and independently conducted 12-family double blinded, double placebo-controlled, multi-phase (6 weeks per phase) pilot study of ASD children ages 4-17* has been completed.
This extensive study which began 24 months ago, used the FDA-cleared, Class II, AVACEN 100 dry heat therapy device to simulate a low-grade fever by non-invasively infusing heat into the circulatory system.
The Fielding Graduate University IRB approved study is entitled: "The Fever Effect: Do kids with autism do better when they use a device to warm their blood? Effects of a six-week AVACEN Treatment Method on Autism Spectrum Disorder". It examined improvements in the Childhood Autism Rating Scale and the Parental Stress Scale.
The study also evaluated changes in pragmatic language and behavior, parents stress levels, Autism symptom severity and reductions in sleep problems previously reported by parents of ASD children and adolescents using the AVACEN 100.
According to Frances Poteet, Graduate Researcher at Fielding Graduate University in Santa Barbara, California who acted as Principal Investigator: "We have seen exciting results relating to improved sleep quality and quantity without the use of medications. This is significant because sleep problems are among the most urgent concerns for families coping with ASD."
Joshua Feder M.D., a board-certified family and child psychiatrist practicing in Solana Beach, California acted as Study Advisor. Dr. Feder, who researches ASD commented; "Although the size of this study is small, this study offers new insights in the evaluation of treatments by rating video samples of subjects before and after treatment."
ASD Fever Effect
In 1980, when a viral infection swept through a therapeutic nursery for children with autism at Bellevue Psychiatric Hospital in New York, the hospital staff reported that the children were more social, alert, and talkative while feverish (Sullivan, 1980). When their fevers faded, so did those behavioral improvements. Unraveling the "fever effect" could lead to innovative ways to improve the lives of individuals affected by ASD.
The Autism Society estimates that 70 million people worldwide have ASD. Research on the costs associated with ASD conducted in the United States (e.g. Croen, et al. 2006) determined that the average cost for children with ASD were twice as high as other children for hospitalization, clinic visits, and prescription medications.
About Fielding Graduate University
Fielding Graduate University, a private university in Santa Barbara, California was founded in 1974 by Frederic M. Hudson, Hallock Hoffman, and Renata Tesch.
They designed Fielding as a graduate program for mid-career professionals who were not being served by traditional universities.
It offers postgraduate and doctoral studies mainly in psychology, education, and organizational studies.
About AVACEN Medical
AVACEN Medical www.AVACEN.com is dedicated to the innovation and design of safe, easy to use, noninvasive drug-free alternatives for the management of pain associated with numerous chronic and acute conditions including the temporary relief of minor muscle and joint pain and stiffness associated with arthritis and potentially other conditions that can cause joint pain, such as CRPS, Reynaud's, and Lyme Disease. Founded in 2009, AVACEN Medical is headquartered in San Diego. Contact: Thomas Muehlbauer, CEO at (888) 428-2236 x 701 or firstname.lastname@example.org.
E.U. Approval: A heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; the temporary relief of widespread pain associated with fibromyalgia; muscular relaxation; and the temporary increase of microcirculation.
U.S. FDA-Clearance: A heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.
IMPORTANT: The AVACEN 100 is not for sale in the U.S. or E.U. for any non-cleared or non-approved indication mentioned in this document.
*AVACEN recommends parents contact a physician before using the AVACEN 100 on those under 18 years of age.
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SOURCE AVACEN Medical