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

NCT02195401 | Completed DMC

• 1 other identifier: 09-131
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism

Keywords

autism, cleanroom, immune dysregulation, toxins

Outcome Measures

Primary Outcomes (1)

• Change in blood and hair elemental concentrations

  Within one day pre and post 2 week experience of sleeping in the cleanroom

Secondary Outcomes (1)

• Change of xenobiotic chemical concentrations

  Within one day pre and post two week time the children sleep in the cleanroom

Other Outcomes (1)

• Change of T and B cell subset results

  Within one day pre and post the two week period the children sleep in the cleanroom

Study Arms (1)

Sleeping in a cleanroom

Each child and his or her parent slept in a cleanroom for two weeks. Within 24 hours pre and post this two week experience blood and hair samples were taken from the children and the parents filled out rating scales.

Other: Cleanroom

Interventions

Cleanroom OTHER

Cleanroom with air the quality of the pre-industrial age

Sleeping in a cleanroom

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Ten children confirmed to have autism through ADOS

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

Sponsors & Collaborators

• The Children's Institute: lead
• Duquesne University: collaborator
• Health Resources and Services Administration (HRSA): collaborator

Study Sites (1)

The Children's Institute

Pittsburgh, Pennsylvania, 15217, United States

Location

Related Publications (1)

• Faber S, Zinn GM, Boggess A, Fahrenholz T, Kern JC 2nd, Kingston HM. A cleanroom sleeping environment's impact on markers of oxidative stress, immune dysregulation, and behavior in children with autism spectrum disorders. BMC Complement Altern Med. 2015 Mar 19;15:71. doi: 10.1186/s12906-015-0564-0.

  PMID: 25887094 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Scott Faber, MD

  The Children's Institute

  PRINCIPAL INVESTIGATOR

• Skip Kingston, Ph.D.

  Duquesne University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Developmental Pediatrician

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 21, 2014
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 21, 2014

Record last verified: 2014-07

Locations

US (1)