Sleep ProblemsRESTNCT00691080
Understanding Sleep Problems in Children With Autism Spectrum Disorder
An observational study of Sleep Problems, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
The investigators will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important role in regulating sleep-wake cycle. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems
- How many people
- 58 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2007to Nov 2011
- 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 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with the diagnosis of ASD and that are not diagnosised with ASD (controls).
Who may be able to join
- Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects).
- Age greater than or equal to 4 or less than or equal to 9 years;
- Parents have given informed consent.
- Parent/Caregiver fluent in written and spoken English.
- Controls only: A SCQ score of less than 10 without parental or physician concern for another neurodevelopmental disorder will be used to define normal children.
Who cannot join
- Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.)*;
- Current or use within the last 1 month of beta-blockers or melatonin;
- Current use of sleep aids;
- Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD);
- Blindness.
- Controls only: current or past diagnosis of ADHD, depression, anxiety or with any other psychiatric conditions. (7) Controls only: Sibling has a diagnosis of Autism Spectrum Disorder.
- Psychoactive medications can be discontinued but the parents must discuss medication discontinuation with their prescribing physician prior to reducing or stopping the medications.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor College of Medicine
Houston, Texas, 77030
Columbia University
New York, New York, 10032
Oregon Health & Sciences University
Portland, Oregon, 97239
About this study
Official title: Characterization of Endogenous Melatonin Profiles in Children With Autism Spectrum Disorder.
The investigators will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important role in regulating sleep-wake cycle. Children with ASD experience high rates of sleep disturbances that potentially contribute to problems with thinking and behavior. It is unclear if changes in MT production cause sleep problems in children with ASD. MT is frequently used to treat these sleep problems; however, it has not been well established whether MT is an effective treatment. Our hypotheses concerning MT is children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production. This study will compare children diagnosed with ASD to "healthy" control children with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College of Medicine, Oregon Health \& Science University and Columbia University. The investigators will use a standardized questionnaire to determine whether the child has sleep problems. The investigators will measure MT levels in saliva in ASD children with sleep problems and in a group of control children without sleep problems. Total 24-hour MT production will be determined from urine samples in these same two groups.
Read the detailed description
This is a proposal to study the relationship between melatonin (MT) and sleep problems in children with autism spectrum disorder (ASD), as part of the collaborative research structure of the Autism Treatment Network (ATN). A major goal of the ATN is to conduct clinical research that will have a significant impact on the daily lives and functioning of individuals with ASD and to address immediate concerns of parents. Children with ASD experience high rates of sleep disturbance, which likely contribute to the severity of their daytime cognitive and behavioral dysfunction and to poorer quality of life for them and their families.
As a step toward addressing sleep problems in ASD, we propose to test the hypothesis that children with ASD and sleep problems will have a delay in MT onset and/or have decreased MT secretion over 24 hours compared to normal controls.
Primary endpoint: Characterize the endogenous MT profiles in children with ASD:
We predict that results from this study will reveal lower levels of metabolized MT in children with ASD when compared to normal children. In addition, we anticipate that children with ASD will have delayed MT onset or altered circadian phase.
Data from this study will provide important information concerning circadian rhythm dysregulation in ASD and will support the development of future studies using MT to modify and correct abnormal circadian rhythms.
- Conditions
- Sleep Problems
- Keywords
- Melatonin, Sleep, Autism, ASD, Sleep problems in children with autism spectrum disorder
- Medical subject headings
- Parasomnias, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ASD children | ASD children as defined by: 1. Age greater than or equal to 4 or less than or equal to 9 years 2. Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects). 3. No current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.) 4. No current or use within the last 1 month of beta-blockers or melatonin 5. No current use of sleep aids 6. No presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD) (6) No blindness. | |
| "Healthy" control children | "Healthy" control children as defined by: 1. Age greater than or equal to 4 or less than or equal to 9 years 2. A SCQ score of less than 10 without parental or physician concern for another neurodevelopmental disorder will be used to define normal children. 3. No current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.) 4. No current or use within the last 1 month of beta-blockers or melatonin 5. No current use of sleep aids; 6. No presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD) (6) No blindness. (7) No current or past diagnosis of ADHD, depression, anxiety or with any other psychiatric conditions. (8) No sibling with a diagnosis of Autism Spectrum Disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Latency, as measured by actigraphy
Measured: 1 week
Secondary outcomes (1)
Total sleep time, as measured by actigraphy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Autism Speaks, Oregon Health and Science University, Columbia University, The Emmes Company, LLC, Autism Treatment Network
- Responsible party
- Principal investigator, Daniel Glaze, Baylor College of Medicine
- Investigators
- Daniel G Glaze, M.D., Study director, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691080
- Sponsor's protocol ID
- 2003
- Acronym
- REST
- Status last verified
- Jan 2016
- First submitted
- 3 Jun 2008
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Couturier JL, Speechley KN, Steele M, Norman R, Stringer B, Nicolson R. Parental perception of sleep problems in children of normal intelligence with pervasive developmental disorders: prevalence, severity, and pattern. J Am Acad Child Adolesc Psychiatry. 2005 Aug;44(8):815-22. doi: 10.1097/01.chi.0000166377.22651.87.
PubMed 16034284Wiggs L, Stores G. Severe sleep disturbance and daytime challenging behaviour in children with severe learning disabilities. J Intellect Disabil Res. 1996 Dec;40 ( Pt 6):518-28. doi: 10.1046/j.1365-2788.1996.799799.x.
PubMed 9004112Patzold LM, Richdale AL, Tonge BJ. An investigation into sleep characteristics of children with autism and Asperger's Disorder. J Paediatr Child Health. 1998 Dec;34(6):528-33. doi: 10.1046/j.1440-1754.1998.00291.x.
PubMed 9928644Richdale AL, Prior MR. The sleep/wake rhythm in children with autism. Eur Child Adolesc Psychiatry. 1995 Jul;4(3):175-86. doi: 10.1007/BF01980456.
PubMed 8846206Fallone G, Acebo C, Arnedt JT, Seifer R, Carskadon MA. Effects of acute sleep restriction on behavior, sustained attention, and response inhibition in children. Percept Mot Skills. 2001 Aug;93(1):213-29. doi: 10.2466/pms.2001.93.1.213.
PubMed 11693688Polimeni MA, Richdale AL, Francis AJ. A survey of sleep problems in autism, Asperger's disorder and typically developing children. J Intellect Disabil Res. 2005 Apr;49(Pt 4):260-8. doi: 10.1111/j.1365-2788.2005.00642.x.
PubMed 15816813Giannotti F, Cortesi F, Cerquiglini A, Bernabei P. An open-label study of controlled-release melatonin in treatment of sleep disorders in children with autism. J Autism Dev Disord. 2006 Aug;36(6):741-52. doi: 10.1007/s10803-006-0116-z.
PubMed 16897403Allik H, Larsson JO, Smedje H. Insomnia in school-age children with Asperger syndrome or high-functioning autism. BMC Psychiatry. 2006 Apr 28;6:18. doi: 10.1186/1471-244X-6-18.
PubMed 16646974Hoshino Y, Watanabe H, Yashima Y, Kaneko M, Kumashiro H. An investigation on sleep disturbance of autistic children. Folia Psychiatr Neurol Jpn. 1984;38(1):45-51. doi: 10.1111/j.1440-1819.1984.tb00353.x.
PubMed 6537391Clements J, Wing L, Dunn G. Sleep problems in handicapped children: a preliminary study. J Child Psychol Psychiatry. 1986 May;27(3):399-407. doi: 10.1111/j.1469-7610.1986.tb01841.x.
PubMed 3733919Quine L. Sleep problems in children with mental handicap. J Ment Defic Res. 1991 Aug;35 ( Pt 4):269-90. doi: 10.1111/j.1365-2788.1991.tb00402.x.
PubMed 1757978Honomichl RD, Goodlin-Jones BL, Burnham M, Gaylor E, Anders TF. Sleep patterns of children with pervasive developmental disorders. J Autism Dev Disord. 2002 Dec;32(6):553-61. doi: 10.1023/a:1021254914276.
PubMed 12553592Schreck KA, Mulick JA. Parental report of sleep problems in children with autism. J Autism Dev Disord. 2000 Apr;30(2):127-35. doi: 10.1023/a:1005407622050.
PubMed 10832777Wiggs L, Stores G. Sleep patterns and sleep disorders in children with autistic spectrum disorders: insights using parent report and actigraphy. Dev Med Child Neurol. 2004 Jun;46(6):372-80. doi: 10.1017/s0012162204000611.
PubMed 15174528Didden R, Korzilius H, van Aperlo B, van Overloop C, de Vries M. Sleep problems and daytime problem behaviours in children with intellectual disability. J Intellect Disabil Res. 2002 Oct;46(Pt 7):537-47. doi: 10.1046/j.1365-2788.2002.00404.x.
PubMed 12354310
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Endogenous Melatonin Profiles in Children With Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT00691080
- Acronym / sponsor ID
- REST / 2003
- Conditions
- Sleep Problems
- Keywords
- Melatonin, Sleep, Autism, ASD, Sleep problems in children with autism spectrum disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Autism Speaks, Oregon Health and Science University, Columbia University, The Emmes Company, LLC, Autism Treatment Network
- Study start
- Sep 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Jun 2008 (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.
The investigators will examine whether sleep problems in children with autism spectrum disorder (ASD) are related to alterations in the production of melatonin (MT), a hormone that plays an important role in regulating sleep-wake cycle. Children with ASD experience high rates of sleep disturbances that potentially contribute to problems with thinking and behavior. It is unclear if changes in MT production cause sleep problems in children with ASD. MT is frequently used to treat these sleep problems; however, it has not been well established whether MT is an effective treatment. Our hypotheses concerning MT is children with ASD and sleep problems will have a delayed sleep-wake cycle and/or decreased MT production. This study will compare children diagnosed with ASD to "healthy" control children with no ASD diagnosis. All subjects will be recruited from one of three sites: Baylor College of Medicine, Oregon Health \& Science University and Columbia University. The investigators will use a standardized questionnaire to determine whether the child has sleep problems. The investigators will measure MT levels in saliva in ASD children with sleep problems and in a group of control children without sleep problems. Total 24-hour MT production will be determined from urine samples in these same two groups.
Detailed description
This is a proposal to study the relationship between melatonin (MT) and sleep problems in children with autism spectrum disorder (ASD), as part of the collaborative research structure of the Autism Treatment Network (ATN). A major goal of the ATN is to conduct clinical research that will have a significant impact on the daily lives and functioning of individuals with ASD and to address immediate concerns of parents. Children with ASD experience high rates of sleep disturbance, which likely contribute to the severity of their daytime cognitive and behavioral dysfunction and to poorer quality of life for them and their families.
As a step toward addressing sleep problems in ASD, we propose to test the hypothesis that children with ASD and sleep problems will have a delay in MT onset and/or have decreased MT secretion over 24 hours compared to normal controls.
Primary endpoint: Characterize the endogenous MT profiles in children with ASD:
We predict that results from this study will reveal lower levels of metabolized MT in children with ASD when compared to normal children. In addition, we anticipate that children with ASD will have delayed MT onset or altered circadian phase.
Data from this study will provide important information concerning circadian rhythm dysregulation in ASD and will support the development of future studies using MT to modify and correct abnormal circadian rhythms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD children | – | –ASD children as defined by: 1. Age greater than or equal to 4 or less than or equal to 9 years 2. Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects). 3. No current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.) 4. No current or use within the last 1 month of beta-blockers or melatonin 5. No current use of sleep aids 6. No presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD) (6) No blindness. |
| "Healthy" control children | – | –"Healthy" control children as defined by: 1. Age greater than or equal to 4 or less than or equal to 9 years 2. A SCQ score of less than 10 without parental or physician concern for another neurodevelopmental disorder will be used to define normal children. 3. No current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.) 4. No current or use within the last 1 month of beta-blockers or melatonin 5. No current use of sleep aids; 6. No presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD) (6) No blindness. (7) No current or past diagnosis of ADHD, depression, anxiety or with any other psychiatric conditions. (8) No sibling with a diagnosis of Autism Spectrum Disorder. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with the diagnosis of ASD and that are not diagnosised with ASD (controls).
Key inclusion criteria (5 listed)
- Diagnosis of Autism Spectrum Disorder; supported by ADOS and the ADI or SCQ (subjects).
- Age greater than or equal to 4 or less than or equal to 9 years;
- Parents have given informed consent.
- Parent/Caregiver fluent in written and spoken English.
- Controls only: A SCQ score of less than 10 without parental or physician concern for another neurodevelopmental disorder will be used to define normal children.
Key exclusion criteria (7 listed)
- Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.)*;
- Current or use within the last 1 month of beta-blockers or melatonin;
- Current use of sleep aids;
- Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease - GERD);
- Blindness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep Latency, as measured by actigraphy
Time frame: 1 week
1 secondary outcome
Total sleep time, as measured by actigraphy
Time frame: 1 week
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 13 Jan 2016.
- Background: PubMed 16034284Couturier JL, Speechley KN, Steele M, Norman R, Stringer B, Nicolson R. Parental perception of sleep problems in children of normal intelligence with pervasive developmental disorders: prevalence, severity, and pattern. J Am Acad Child Adolesc Psychiatry. 2005 Aug;44(8):815-22. doi: 10.1097/01.chi.0000166377.22651.87.
- Background: PubMed 9004112Wiggs L, Stores G. Severe sleep disturbance and daytime challenging behaviour in children with severe learning disabilities. J Intellect Disabil Res. 1996 Dec;40 ( Pt 6):518-28. doi: 10.1046/j.1365-2788.1996.799799.x.
- Background: PubMed 9928644Patzold LM, Richdale AL, Tonge BJ. An investigation into sleep characteristics of children with autism and Asperger's Disorder. J Paediatr Child Health. 1998 Dec;34(6):528-33. doi: 10.1046/j.1440-1754.1998.00291.x.
- Background: PubMed 8846206Richdale AL, Prior MR. The sleep/wake rhythm in children with autism. Eur Child Adolesc Psychiatry. 1995 Jul;4(3):175-86. doi: 10.1007/BF01980456.
- Background: PubMed 11693688Fallone G, Acebo C, Arnedt JT, Seifer R, Carskadon MA. Effects of acute sleep restriction on behavior, sustained attention, and response inhibition in children. Percept Mot Skills. 2001 Aug;93(1):213-29. doi: 10.2466/pms.2001.93.1.213.
- Background: PubMed 15816813Polimeni MA, Richdale AL, Francis AJ. A survey of sleep problems in autism, Asperger's disorder and typically developing children. J Intellect Disabil Res. 2005 Apr;49(Pt 4):260-8. doi: 10.1111/j.1365-2788.2005.00642.x.
- Background: PubMed 16897403Giannotti F, Cortesi F, Cerquiglini A, Bernabei P. An open-label study of controlled-release melatonin in treatment of sleep disorders in children with autism. J Autism Dev Disord. 2006 Aug;36(6):741-52. doi: 10.1007/s10803-006-0116-z.
- Background: PubMed 16646974Allik H, Larsson JO, Smedje H. Insomnia in school-age children with Asperger syndrome or high-functioning autism. BMC Psychiatry. 2006 Apr 28;6:18. doi: 10.1186/1471-244X-6-18.
- Background: PubMed 6537391Hoshino Y, Watanabe H, Yashima Y, Kaneko M, Kumashiro H. An investigation on sleep disturbance of autistic children. Folia Psychiatr Neurol Jpn. 1984;38(1):45-51. doi: 10.1111/j.1440-1819.1984.tb00353.x.
- Background: PubMed 3733919Clements J, Wing L, Dunn G. Sleep problems in handicapped children: a preliminary study. J Child Psychol Psychiatry. 1986 May;27(3):399-407. doi: 10.1111/j.1469-7610.1986.tb01841.x.
- Background: PubMed 1757978Quine L. Sleep problems in children with mental handicap. J Ment Defic Res. 1991 Aug;35 ( Pt 4):269-90. doi: 10.1111/j.1365-2788.1991.tb00402.x.
- Background: PubMed 12553592Honomichl RD, Goodlin-Jones BL, Burnham M, Gaylor E, Anders TF. Sleep patterns of children with pervasive developmental disorders. J Autism Dev Disord. 2002 Dec;32(6):553-61. doi: 10.1023/a:1021254914276.
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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.
Daniel G Glaze, M.D. study director
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Problems, run by Baylor College of Medicine at 3 sites 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 5 inclusion and 7 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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Sleep Latency, as measured by actigraphy (time frame: 1 week). 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 NCT00691080, which also lists 50 linked publications.
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 13 Jan 2016.