AutismNCT02195401
The Effects of a Clean Room Sleeping Environment on Elemental and Chemical Concentrations in Children With Autism
An observational study of Autism, run by The Children's Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 21 years
- Conditions the study is for
- Autism
- What is being tested?
- Cleanroom
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Ten children confirmed to have autism through ADOS
Who may be able to join
- 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
Who cannot join
- Children who are behaviorally severely dysregulated
- Children with other chronic medical conditions that require close monitoring
- Children with uncontrolled seizure disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Institute
Pittsburgh, Pennsylvania, 15217
About this study
Official title: The Effects of a Clean Room Sleeping Environment on Elemental and Chemical Concentrations in Children and Adolescents With Autism Spectrum Disorders
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.
Read the detailed 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.
- Conditions
- Autism
- Being tested
- Cleanroom
- Keywords
- autism, cleanroom, immune dysregulation, toxins
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleanroomOther
Cleanroom with air the quality of the pre-industrial age
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cleanroom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood and hair elemental concentrations
Measured: Within one day pre and post 2 week experience of sleeping in the cleanroom
Secondary outcomes (1)
Change of xenobiotic chemical concentrations
Measured: Within one day pre and post two week time the children sleep in the cleanroom
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Children's Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Duquesne University, Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Dr. Scott Faber, The Children's Institute
- Investigators
- Scott Faber, MD, Principal investigator, The Children's InstituteSkip Kingston, Ph.D., Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195401
- Sponsor's protocol ID
- 09-131
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2014
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25887094
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Clean Room Sleeping Environment on Elemental and Chemical Concentrations in Children and Adolescents With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02195401
- Acronym / sponsor ID
- 09-131
- Conditions
- Autism
- Keywords
- autism, cleanroom, immune dysregulation, toxins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Children's InstituteUniversity, hospital or other
- Collaborators
- Duquesne University, Health Resources and Services Administration (HRSA)
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleeping in a cleanroom | – | Other: CleanroomEach 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. |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Ten children confirmed to have autism through ADOS
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Children who are behaviorally severely dysregulated
- Children with other chronic medical conditions that require close monitoring
- Children with uncontrolled seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CleanroomCleanroom with air the quality of the pre-industrial age | Other | Sleeping in a cleanroom |
Primary outcome
Change in blood and hair elemental concentrations
Time frame: Within one day pre and post 2 week experience of sleeping in the cleanroom
1 secondary outcome
Change of xenobiotic chemical concentrations
Time frame: Within one day pre and post two week time the children sleep in the cleanroom
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Derived from this study: PubMed 25887094Faber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Faber, MD principal investigator
The Children's Institute
Skip Kingston, Ph.D. principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism, run by The Children's Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood and hair elemental concentrations (time frame: Within one day pre and post 2 week experience of sleeping in the cleanroom). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02195401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.