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

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195401
• Other study ID #: 09-131
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: July 17, 2014
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: July 2014
• Source: The Children's Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

Autism spectrum disorders are characterized behaviorally by expressive language and social deficits, the performance of stereotypic and repetitive behavior patterns, and abnormal cognitive functioning. Children with autism spectrum disorders often do not have known anomalies seen on genetic testing. An emerging paradigm suggests that the majority of children with autism are displaying a pattern of genetic / environmental interaction that make them susceptible to difficulties with detoxification of the heavy metal and chemical environment. Children with autism demonstrate increased difficulty with the performance of methylation and sulfation required for the elimination of fat soluble chemicals from human tissues. These children also commonly display dysfunction of their metalloprotein systems necessary for the elimination of heavy metals such as mercury and arsenic from their bodies.

This study sought to provide 10 children with autism an opportunity to sleep in a clean room environment, a hospital room that was modified to remove nearly all traces of particulate matter, chemicals, and heavy metals, for a 2 week period while going about their normal activities during the day. In the clean room, the children slept on bedding and wore clothes that did not release any toxins. This room created a concentration gradient for chemical and heavy metal toxins that may have allowed these toxins to leave the children's bodies during their stays.

The children's parents filled out seven rating scales, including the Aberrant Behavior Checklist, immediately before and after the 2 week sleeping periods. The children had blood samples taken before and after the 2 week sleeping experiences that measured biomarkers of metalloprotein (heavy metal elimination) and immune functioning, such as the plasma zinc/serum copper ratio and T and B cell subsets. Red blood cell and hair concentrations of toxic heavy metals such as mercury, arsenic, and chromium 6, and red blood cell concentrations of chemicals implicated in contributing to human pathology, including polychlorinated biphenyls (PCBs), polybrominated diethyl ethers (PBDEs), and phthalates were determined before and after the sleeping experiences. These pre and post stay variables were statistically compared, and it was hypothesized that the children's red blood cell concentrations of toxins would be significantly reduced while their hair concentrations of toxins would be significantly increased after their sleeping experiences in the clean room, supporting the concept that the clean room promoted the release of heavy metals and chemicals from their bodies. This one year study was a proof of concept cohort study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Children who are behaviorally severely dysregulated

• Children with other chronic medical conditions that require close monitoring

• Children with uncontrolled seizure disorder

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Other:
• Cleanroom
Cleanroom with air the quality of the pre-industrial age

Locations

Country	Name	City	State
United States	The Children's Institute	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
The Children's Institute	Duquesne University, Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of T and B cell subset results		Within one day pre and post the two week period the children sleep in the cleanroom	No
Primary	Change in blood and hair elemental concentrations		Within one day pre and post 2 week experience of sleeping in the cleanroom	No
Secondary	Change of xenobiotic chemical concentrations		Within one day pre and post two week time the children sleep in the cleanroom	No