Lung DiseasesNCT00006321
Neurocognitive Function in Snoring Children
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by University of Louisville.
Trial summary
To assess associations between behavioral/neuropsychological measures and various measures of sleep disordered breathing (SDB) and to determine the prevalence of SDB in children with Attention Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Lung Diseases, Sleep Apnea Syndromes, Neurologic Manifestations
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 1999to Jun 2008
- 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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with attention deficit hyperactivity disorder
Subjects with ADHD
About this study
To assess associations between behavioral/neuropsychological measures and various measures of sleep disordered breathing (SDB) and to determine the prevalence of SDB in children with Attention Deficit Hyperactivity Disorder (ADHD).
Read the detailed description
BACKGROUND:
Obstructive sleep apnea syndrome (OSAS) is a relatively frequent condition which may affect up to 2-3 percent of school age children. The morbidity of untreated OSAS may include failure to thrive, pulmonary and systemic hypertension, and behavioral and neurocognitive deficiencies. However, it remains unclear to what extent OSAS impinges on aspects of neurocognitive and behavioral function, and whether sleep fragmentation, intermittent hypoxemia, and alveolar hypoventilation, which are the three major physiological alterations in OSAS, selectively affect particularly vulnerable components of neurocognitive function. Furthermore, certain similarities exist between the behavioral alterations occurring in OSAS and those seen in children with the Attention Deficit Hyperactivity Disorder (ADHD).
The study is in response to a Request for Applications (RFA) on Obstructive Sleep Apnea in Children. NHLBI issued the RFA in December, 1997, with co-sponsorship from the National Institute of Dental and Craniofacial Research and the National Institute of Child Health and Human Development.
DESIGN NARRATIVE:
The cross-sectional study tested the hypothesis that OSAS is detrimental to particular aspects of neurocognitive and behavioral functioning. Snoring 6 year-old children attending the public elementary school system in New Orleans Parish were prospectively identified by an appropriate questionnaire and enrolled in the study. Snoring children underwent overnight polysomnographic assessment to determine the presence and severity of OSAS, and their neurocognitive and behavioral functions were subsequently evaluated employing the Wechsler Intelligence Scale for Children-III, the Conners' Continuous Performance Test, and the Cambridge Neuropsychological Test Automated Battery test. Multivariate regression and analyses of variance allowed for determination of aspects of neurocognitive function and behavior that were vulnerable to OSAS in general, and to each of OSAS components in particular.
The study also tested the hypothesis that children with ADHD may have increased prevalence of snoring and OSAS. Children with this diagnosis were initially confirmed as having ADHD using the revised Diagnostic Interview for Children and Adolescents, the Conners' Parent Rating Scale, and the Child Behavior Checklist. ADHD children then underwent polysomnographic evaluation as well as extensive evaluation of neurocognitive function and behavior as above. The prevalence of snoring and OSAS were then calculated.
The study was extended through June 2007 to test the hypothesis that SDB will induce systemic inflammatory responses, and that the magnitude of such inflammatory response will be the major determinant of the severity of neurocognitive dysfunction associated with SDB.
- Medical subject headings
- Lung Diseases, Sleep Apnea Syndromes, Neurologic Manifestations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2000 (estimated)
- Study startSep 1999
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: PI left the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- David Gozal, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006321
- Sponsor's protocol ID
- 924
- Other IDs
- R01HL065270
- Status last verified
- Apr 2017
- First submitted
- 2 Oct 2000
- Last updated
- 10 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gozal D, Simakajornboon N. Passive motion of the extremities modifies alveolar ventilation during sleep in patients with congenital central hypoventilation syndrome. Am J Respir Crit Care Med. 2000 Nov;162(5):1747-51. doi: 10.1164/ajrccm.162.5.2005012.
PubMed 11069807O'Brien LM, Gozal D. Behavioural and neurocognitive implications of snoring and obstructive sleep apnoea in children: facts and theory. Paediatr Respir Rev. 2002 Mar;3(1):3-9. doi: 10.1053/prrv.2002.0177.
PubMed 12065176Gozal D. Morbidity of obstructive sleep apnea in children: facts and theory. Sleep Breath. 2001;5(1):35-42. doi: 10.1007/s11325-001-0035-3.
PubMed 11868138Ivanenko A, Crabtree VM, Tauman R, Gozal D. Melatonin in children and adolescents with insomnia: a retrospective study. Clin Pediatr (Phila). 2003 Jan-Feb;42(1):51-8. doi: 10.1177/000992280304200108.
PubMed 12635982O'Brien LM, Holbrook CR, Mervis CB, Klaus CJ, Bruner JL, Raffield TJ, Rutherford J, Mehl RC, Wang M, Tuell A, Hume BC, Gozal D. Sleep and neurobehavioral characteristics of 5- to 7-year-old children with parentally reported symptoms of attention-deficit/hyperactivity disorder. Pediatrics. 2003 Mar;111(3):554-63. doi: 10.1542/peds.111.3.554.
PubMed 12612236Beebe DW, Gozal D. Obstructive sleep apnea and the prefrontal cortex: towards a comprehensive model linking nocturnal upper airway obstruction to daytime cognitive and behavioral deficits. J Sleep Res. 2002 Mar;11(1):1-16. doi: 10.1046/j.1365-2869.2002.00289.x.
PubMed 11869421Gozal D, Lipton AJ, Jones KL. Circulating vascular endothelial growth factor levels in patients with obstructive sleep apnea. Sleep. 2002 Feb 1;25(1):59-65. doi: 10.1093/sleep/25.1.59.
PubMed 11833862Crabtree VM, Ivanenko A, Gozal D. Clinical and parental assessment of sleep in children with attention-deficit/hyperactivity disorder referred to a pediatric sleep medicine center. Clin Pediatr (Phila). 2003 Nov-Dec;42(9):807-13. doi: 10.1177/000992280304200906.
PubMed 14686552Montgomery-Downs HE, Jones VF, Molfese VJ, Gozal D. Snoring in preschoolers: associations with sleepiness, ethnicity, and learning. Clin Pediatr (Phila). 2003 Oct;42(8):719-26. doi: 10.1177/000992280304200808.
PubMed 14601921O'Brien LM, Ivanenko A, Crabtree VM, Holbrook CR, Bruner JL, Klaus CJ, Gozal D. The effect of stimulants on sleep characteristics in children with attention deficit/hyperactivity disorder. Sleep Med. 2003 Jul;4(4):309-16. doi: 10.1016/s1389-9457(03)00071-6.
PubMed 14592303Simakajornboon N, Gozal D, Vlasic V, Mack C, Sharon D, McGinley BM. Periodic limb movements in sleep and iron status in children. Sleep. 2003 Sep;26(6):735-8. doi: 10.1093/sleep/26.6.735.
PubMed 14572128Gozal D, Burnside MM. Increased upper airway collapsibility in children with obstructive sleep apnea during wakefulness. Am J Respir Crit Care Med. 2004 Jan 15;169(2):163-7. doi: 10.1164/rccm.200304-590OC. Epub 2003 Oct 2.
PubMed 14525806Shouldice RB, O'Brien LM, O'Brien C, de Chazal P, Gozal D, Heneghan C. Detection of obstructive sleep apnea in pediatric subjects using surface lead electrocardiogram features. Sleep. 2004 Jun 15;27(4):784-92. doi: 10.1093/sleep/27.4.784.
PubMed 15283015O'Brien LM, Mervis CB, Holbrook CR, Bruner JL, Klaus CJ, Rutherford J, Raffield TJ, Gozal D. Neurobehavioral implications of habitual snoring in children. Pediatrics. 2004 Jul;114(1):44-9. doi: 10.1542/peds.114.1.44.
PubMed 15231906O'Brien LM, Mervis CB, Holbrook CR, Bruner JL, Smith NH, McNally N, McClimment MC, Gozal D. Neurobehavioral correlates of sleep-disordered breathing in children. J Sleep Res. 2004 Jun;13(2):165-72. doi: 10.1111/j.1365-2869.2004.00395.x.
PubMed 15175097
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Function in Snoring Children
- ClinicalTrials.gov ID
- NCT00006321
- Acronym / sponsor ID
- 924
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the university
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 1999 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Oct 2000 (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.
To assess associations between behavioral/neuropsychological measures and various measures of sleep disordered breathing (SDB) and to determine the prevalence of SDB in children with Attention Deficit Hyperactivity Disorder (ADHD).
Detailed description
BACKGROUND:
Obstructive sleep apnea syndrome (OSAS) is a relatively frequent condition which may affect up to 2-3 percent of school age children. The morbidity of untreated OSAS may include failure to thrive, pulmonary and systemic hypertension, and behavioral and neurocognitive deficiencies. However, it remains unclear to what extent OSAS impinges on aspects of neurocognitive and behavioral function, and whether sleep fragmentation, intermittent hypoxemia, and alveolar hypoventilation, which are the three major physiological alterations in OSAS, selectively affect particularly vulnerable components of neurocognitive function. Furthermore, certain similarities exist between the behavioral alterations occurring in OSAS and those seen in children with the Attention Deficit Hyperactivity Disorder (ADHD).
The study is in response to a Request for Applications (RFA) on Obstructive Sleep Apnea in Children. NHLBI issued the RFA in December, 1997, with co-sponsorship from the National Institute of Dental and Craniofacial Research and the National Institute of Child Health and Human Development.
DESIGN NARRATIVE:
The cross-sectional study tested the hypothesis that OSAS is detrimental to particular aspects of neurocognitive and behavioral functioning. Snoring 6 year-old children attending the public elementary school system in New Orleans Parish were prospectively identified by an appropriate questionnaire and enrolled in the study. Snoring children underwent overnight polysomnographic assessment to determine the presence and severity of OSAS, and their neurocognitive and behavioral functions were subsequently evaluated employing the Wechsler Intelligence Scale for Children-III, the Conners' Continuous Performance Test, and the Cambridge Neuropsychological Test Automated Battery test. Multivariate regression and analyses of variance allowed for determination of aspects of neurocognitive function and behavior that were vulnerable to OSAS in general, and to each of OSAS components in particular.
The study also tested the hypothesis that children with ADHD may have increased prevalence of snoring and OSAS. Children with this diagnosis were initially confirmed as having ADHD using the revised Diagnostic Interview for Children and Adolescents, the Conners' Parent Rating Scale, and the Child Behavior Checklist. ADHD children then underwent polysomnographic evaluation as well as extensive evaluation of neurocognitive function and behavior as above. The prevalence of snoring and OSAS were then calculated.
The study was extended through June 2007 to test the hypothesis that SDB will induce systemic inflammatory responses, and that the magnitude of such inflammatory response will be the major determinant of the severity of neurocognitive dysfunction associated with SDB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with attention deficit hyperactivity disorder
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: PI left the university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Background: PubMed 11069807Gozal D, Simakajornboon N. Passive motion of the extremities modifies alveolar ventilation during sleep in patients with congenital central hypoventilation syndrome. Am J Respir Crit Care Med. 2000 Nov;162(5):1747-51. doi: 10.1164/ajrccm.162.5.2005012.
- Background: PubMed 12065176O'Brien LM, Gozal D. Behavioural and neurocognitive implications of snoring and obstructive sleep apnoea in children: facts and theory. Paediatr Respir Rev. 2002 Mar;3(1):3-9. doi: 10.1053/prrv.2002.0177.
- Background: PubMed 11868138Gozal D. Morbidity of obstructive sleep apnea in children: facts and theory. Sleep Breath. 2001;5(1):35-42. doi: 10.1007/s11325-001-0035-3.
- Background: PubMed 12635982Ivanenko A, Crabtree VM, Tauman R, Gozal D. Melatonin in children and adolescents with insomnia: a retrospective study. Clin Pediatr (Phila). 2003 Jan-Feb;42(1):51-8. doi: 10.1177/000992280304200108.
- Background: PubMed 12612236O'Brien LM, Holbrook CR, Mervis CB, Klaus CJ, Bruner JL, Raffield TJ, Rutherford J, Mehl RC, Wang M, Tuell A, Hume BC, Gozal D. Sleep and neurobehavioral characteristics of 5- to 7-year-old children with parentally reported symptoms of attention-deficit/hyperactivity disorder. Pediatrics. 2003 Mar;111(3):554-63. doi: 10.1542/peds.111.3.554.
- Background: PubMed 11869421Beebe DW, Gozal D. Obstructive sleep apnea and the prefrontal cortex: towards a comprehensive model linking nocturnal upper airway obstruction to daytime cognitive and behavioral deficits. J Sleep Res. 2002 Mar;11(1):1-16. doi: 10.1046/j.1365-2869.2002.00289.x.
- Background: PubMed 11833862Gozal D, Lipton AJ, Jones KL. Circulating vascular endothelial growth factor levels in patients with obstructive sleep apnea. Sleep. 2002 Feb 1;25(1):59-65. doi: 10.1093/sleep/25.1.59.
- Background: PubMed 14686552Crabtree VM, Ivanenko A, Gozal D. Clinical and parental assessment of sleep in children with attention-deficit/hyperactivity disorder referred to a pediatric sleep medicine center. Clin Pediatr (Phila). 2003 Nov-Dec;42(9):807-13. doi: 10.1177/000992280304200906.
- Background: PubMed 14601921Montgomery-Downs HE, Jones VF, Molfese VJ, Gozal D. Snoring in preschoolers: associations with sleepiness, ethnicity, and learning. Clin Pediatr (Phila). 2003 Oct;42(8):719-26. doi: 10.1177/000992280304200808.
- Background: PubMed 14592303O'Brien LM, Ivanenko A, Crabtree VM, Holbrook CR, Bruner JL, Klaus CJ, Gozal D. The effect of stimulants on sleep characteristics in children with attention deficit/hyperactivity disorder. Sleep Med. 2003 Jul;4(4):309-16. doi: 10.1016/s1389-9457(03)00071-6.
- Background: PubMed 14572128Simakajornboon N, Gozal D, Vlasic V, Mack C, Sharon D, McGinley BM. Periodic limb movements in sleep and iron status in children. Sleep. 2003 Sep;26(6):735-8. doi: 10.1093/sleep/26.6.735.
- Background: PubMed 14525806Gozal D, Burnside MM. Increased upper airway collapsibility in children with obstructive sleep apnea during wakefulness. Am J Respir Crit Care Med. 2004 Jan 15;169(2):163-7. doi: 10.1164/rccm.200304-590OC. Epub 2003 Oct 2.
- Individual participant dataSharing planned: Undecided
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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.
David Gozal principal investigator
University of Louisville
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by University of Louisville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: PI left the university). Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006321, which also lists 28 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 10 Apr 2017.