The Effects of a Clean Room Sleeping Environment on Elemental and Chemical Concentrations in Children With Autism

Completed

Conditions studied: Autism

In brief

A child and their parent were asked to participate in a research project that sought to study whether sleeping in a very clean environment for 14 days improved the elimination of chemicals and metals from the child's body. The child had an approximately two hour evaluation to confirm his or her diagnosis of Autism or Pervasive Developmental Disorder. Not Otherwise Specified. When one of these diagnoses was confirmed the child was scheduled to spend 14 nights sleeping in a very clean environment in a specially created room at The Children's Institute. Several hours prior to the first night the child slept in the clean room the child's mother, father, or guardian filled out behavioral rating scales about the child with the assistance of the study's research coordinator. The child also had approximately two tablespoons of blood drawn from an arm and a few inch sample of hair was taken from the back of the child's head. The child and a parent or guardian arrived at The Children's Institute about one half hour prior to the child's normal time of settling for bed for 14 consecutive nights. The child and a parent or guardian slept in the clean room, wearing the provided very clean clothes and sleeping on special mattresses and sheets each night for 14 consecutive nights. The child and parent were observed by a nurse through a window during the time in the clean room. The child and parent participated in regular daytime activities during these 14 days of the study. On the morning after the last night the child and a parent or guardian slept in the clean room a parent or guardian filled out behavioral rating scales with the help of the research coordinator. Approximately two tablespoons of blood were drawn from an arm and a few inch sample of hair was obtained from the back of the child's head, at The Children's Institute or at home.

Key facts

Study ID

NCT02195401

Run by

The Children's Institute

People needed

10

Starts

2010-05-01

Expected to finish

2010-10-01

Last updated by the study team

2014-07-21

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of autism or Pervasive Developmental Disorder . Not Otherwise Specified
• Age 3-21
• Delayed verbal ability and limited academic skill sets that are advancing slowly with current programming

You may not qualify if…

• Children who are behaviorally severely dysregulated
• Children with other chronic medical conditions that require close monitoring
• Children with uncontrolled seizure disorder

Where it is running

• The Children's Institute — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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