<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02195401</url>
  </required_header>
  <id_info>
    <org_study_id>09-131</org_study_id>
    <nct_id>NCT02195401</nct_id>
  </id_info>
  <brief_title>The Effects of a Clean Room Sleeping Environment on Elemental and Chemical Concentrations in Children With Autism</brief_title>
  <official_title>The Effects of a Clean Room Sleeping Environment on Elemental and Chemical Concentrations in Children and Adolescents With Autism Spectrum Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Children's Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duquesne University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Health Resources and Services Administration (HRSA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>The Children's Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A child and their parent were asked to participate in a research project that sought to study&#xD;
      whether sleeping in a very clean environment for 14 days improved the elimination of&#xD;
      chemicals and metals from the child's body. The child had an approximately two hour&#xD;
      evaluation to confirm his or her diagnosis of Autism or Pervasive Developmental Disorder. Not&#xD;
      Otherwise Specified. When one of these diagnoses was confirmed the child was scheduled to&#xD;
      spend 14 nights sleeping in a very clean environment in a specially created room at The&#xD;
      Children's Institute.&#xD;
&#xD;
      Several hours prior to the first night the child slept in the clean room the child's mother,&#xD;
      father, or guardian filled out behavioral rating scales about the child with the assistance&#xD;
      of the study's research coordinator. The child also had approximately two tablespoons of&#xD;
      blood drawn from an arm and a few inch sample of hair was taken from the back of the child's&#xD;
      head. The child and a parent or guardian arrived at The Children's Institute about one half&#xD;
      hour prior to the child's normal time of settling for bed for 14 consecutive nights. The&#xD;
      child and a parent or guardian slept in the clean room, wearing the provided very clean&#xD;
      clothes and sleeping on special mattresses and sheets each night for 14 consecutive nights.&#xD;
      The child and parent were observed by a nurse through a window during the time in the clean&#xD;
      room. The child and parent participated in regular daytime activities during these 14 days of&#xD;
      the study. On the morning after the last night the child and a parent or guardian slept in&#xD;
      the clean room a parent or guardian filled out behavioral rating scales with the help of the&#xD;
      research coordinator. Approximately two tablespoons of blood were drawn from an arm and a few&#xD;
      inch sample of hair was obtained from the back of the child's head, at The Children's&#xD;
      Institute or at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autism spectrum disorders are characterized behaviorally by expressive language and social&#xD;
      deficits, the performance of stereotypic and repetitive behavior patterns, and abnormal&#xD;
      cognitive functioning. Children with autism spectrum disorders often do not have known&#xD;
      anomalies seen on genetic testing. An emerging paradigm suggests that the majority of&#xD;
      children with autism are displaying a pattern of genetic / environmental interaction that&#xD;
      make them susceptible to difficulties with detoxification of the heavy metal and chemical&#xD;
      environment. Children with autism demonstrate increased difficulty with the performance of&#xD;
      methylation and sulfation required for the elimination of fat soluble chemicals from human&#xD;
      tissues. These children also commonly display dysfunction of their metalloprotein systems&#xD;
      necessary for the elimination of heavy metals such as mercury and arsenic from their bodies.&#xD;
&#xD;
      This study sought to provide 10 children with autism an opportunity to sleep in a clean room&#xD;
      environment, a hospital room that was modified to remove nearly all traces of particulate&#xD;
      matter, chemicals, and heavy metals, for a 2 week period while going about their normal&#xD;
      activities during the day. In the clean room, the children slept on bedding and wore clothes&#xD;
      that did not release any toxins. This room created a concentration gradient for chemical and&#xD;
      heavy metal toxins that may have allowed these toxins to leave the children's bodies during&#xD;
      their stays.&#xD;
&#xD;
      The children's parents filled out seven rating scales, including the Aberrant Behavior&#xD;
      Checklist, immediately before and after the 2 week sleeping periods. The children had blood&#xD;
      samples taken before and after the 2 week sleeping experiences that measured biomarkers of&#xD;
      metalloprotein (heavy metal elimination) and immune functioning, such as the plasma&#xD;
      zinc/serum copper ratio and T and B cell subsets. Red blood cell and hair concentrations of&#xD;
      toxic heavy metals such as mercury, arsenic, and chromium 6, and red blood cell&#xD;
      concentrations of chemicals implicated in contributing to human pathology, including&#xD;
      polychlorinated biphenyls (PCBs), polybrominated diethyl ethers (PBDEs), and phthalates were&#xD;
      determined before and after the sleeping experiences. These pre and post stay variables were&#xD;
      statistically compared, and it was hypothesized that the children's red blood cell&#xD;
      concentrations of toxins would be significantly reduced while their hair concentrations of&#xD;
      toxins would be significantly increased after their sleeping experiences in the clean room,&#xD;
      supporting the concept that the clean room promoted the release of heavy metals and chemicals&#xD;
      from their bodies. This one year study was a proof of concept cohort study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">October 2010</completion_date>
  <primary_completion_date type="Actual">October 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in blood and hair elemental concentrations</measure>
    <time_frame>Within one day pre and post 2 week experience of sleeping in the cleanroom</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of xenobiotic chemical concentrations</measure>
    <time_frame>Within one day pre and post two week time the children sleep in the cleanroom</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of T and B cell subset results</measure>
    <time_frame>Within one day pre and post the two week period the children sleep in the cleanroom</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Sleeping in a cleanroom</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cleanroom</intervention_name>
    <description>Cleanroom with air the quality of the pre-industrial age</description>
    <arm_group_label>Sleeping in a cleanroom</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Ten children confirmed to have autism through ADOS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of autism or Pervasive Developmental Disorder . Not Otherwise Specified&#xD;
&#xD;
          -  Age 3-21&#xD;
&#xD;
          -  Delayed verbal ability and limited academic skill sets that are advancing slowly with&#xD;
             current programming&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who are behaviorally severely dysregulated&#xD;
&#xD;
          -  Children with other chronic medical conditions that require close monitoring&#xD;
&#xD;
          -  Children with uncontrolled seizure disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Faber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Children's Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Skip Kingston, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duquesne University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>July 17, 2014</last_update_submitted>
  <last_update_submitted_qc>July 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Children's Institute</investigator_affiliation>
    <investigator_full_name>Dr. Scott Faber</investigator_full_name>
    <investigator_title>Developmental Pediatrician</investigator_title>
  </responsible_party>
  <keyword>autism, cleanroom, immune dysregulation, toxins</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02195401
org study id: 09-131
nct id: NCT02195401
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Change in blood and hair elemental concentrations
time frame: Within one day pre and post 2 week experience of sleeping in the cleanroom
measure: Change of xenobiotic chemical concentrations
time frame: Within one day pre and post two week time the children sleep in the cleanroom
measure: Change of T and B cell subset results
time frame: Within one day pre and post the two week period the children sleep in the cleanroom
arm group label: Sleeping in a cleanroom
description: 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.
intervention type: Other
intervention name: Cleanroom
description: Cleanroom with air the quality of the pre-industrial age
arm group label: Sleeping in a cleanroom
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 21 Years
healthy volunteers: No
last name: Scott Faber, MD
role: Principal Investigator
affiliation: The Children's Institute
last name: Skip Kingston, Ph.D.
role: Principal Investigator
affiliation: Duquesne University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Children's Institute
investigator full name: Dr. Scott Faber
investigator title: Developmental Pediatrician
mesh term: Autistic Disorder