NCT00006321

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 1999

Longer than P75 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2000

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

8.8 years

First QC Date

October 2, 2000

Last Update Submit

April 6, 2017

Conditions

Lung DiseasesSleep Apnea SyndromesNeurologic Manifestations

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with attention deficit hyperactivity disorder

Subjects with ADHD

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (28)

  • 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.

    PMID: 11069807BACKGROUND

  • O'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.

    PMID: 12065176BACKGROUND

  • Gozal 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.

    PMID: 11868138BACKGROUND

  • Ivanenko 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.

    PMID: 12635982BACKGROUND

  • O'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.

    PMID: 12612236BACKGROUND

  • Beebe 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.

    PMID: 11869421BACKGROUND

  • Gozal 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.

    PMID: 11833862BACKGROUND

  • Crabtree 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.

    PMID: 14686552BACKGROUND

  • Montgomery-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.

    PMID: 14601921BACKGROUND

  • O'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.

    PMID: 14592303BACKGROUND

  • Simakajornboon 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.

    PMID: 14572128BACKGROUND

  • Gozal 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.

    PMID: 14525806BACKGROUND

  • Shouldice 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.

    PMID: 15283015BACKGROUND

  • O'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.

    PMID: 15231906BACKGROUND

  • O'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.

    PMID: 15175097BACKGROUND

  • Tauman R, Ivanenko A, O'Brien LM, Gozal D. Plasma C-reactive protein levels among children with sleep-disordered breathing. Pediatrics. 2004 Jun;113(6):e564-9. doi: 10.1542/peds.113.6.e564.

    PMID: 15173538BACKGROUND

  • Gozal D. New concepts in abnormalities of respiratory control in children. Curr Opin Pediatr. 2004 Jun;16(3):305-8. doi: 10.1097/01.mop.0000127159.74908.27.

    PMID: 15167018BACKGROUND

  • Ivanenko A, Barnes ME, Crabtree VM, Gozal D. Psychiatric symptoms in children with insomnia referred to a pediatric sleep medicine center. Sleep Med. 2004 May;5(3):253-9. doi: 10.1016/j.sleep.2004.02.001.

    PMID: 15165531BACKGROUND

  • Tauman R, O'Brien LM, Mast BT, Holbrook CR, Gozal D. Peripheral arterial tonometry events and electroencephalographic arousals in children. Sleep. 2004 May 1;27(3):502-6. doi: 10.1093/sleep/27.3.502.

    PMID: 15164906BACKGROUND

  • O'Brien LM, Tauman R, Gozal D. Sleep pressure correlates of cognitive and behavioral morbidity in snoring children. Sleep. 2004 Mar 15;27(2):279-82. doi: 10.1093/sleep/27.2.279.

    PMID: 15124723BACKGROUND

  • Tauman R, O'Brien LM, Holbrook CR, Gozal D. Sleep pressure score: a new index of sleep disruption in snoring children. Sleep. 2004 Mar 15;27(2):274-8. doi: 10.1093/sleep/27.2.274.

    PMID: 15124722BACKGROUND

  • Gozal D, O'Brien L, Row BW. Consequences of snoring and sleep disordered breathing in children. Pediatr Pulmonol Suppl. 2004;26:166-8. doi: 10.1002/ppul.70094. No abstract available.

    PMID: 15029640BACKGROUND

  • O'Brien LM, Gozal D. Neurocognitive dysfunction and sleep in children: from human to rodent. Pediatr Clin North Am. 2004 Feb;51(1):187-202. doi: 10.1016/s0031-3955(03)00184-6.

    PMID: 15008589BACKGROUND

  • Montgomery-Downs HE, O'Brien LM, Holbrook CR, Gozal D. Snoring and sleep-disordered breathing in young children: subjective and objective correlates. Sleep. 2004 Feb 1;27(1):87-94. doi: 10.1093/sleep/27.1.87.

    PMID: 14998242BACKGROUND

  • Gozal D, O'Brien LM. Snoring and obstructive sleep apnoea in children: why should we treat? Paediatr Respir Rev. 2004;5 Suppl A:S371-6. doi: 10.1016/s1526-0542(04)90066-8.

    PMID: 14980299BACKGROUND

  • Vanderlaan M, Holbrook CR, Wang M, Tuell A, Gozal D. Epidemiologic survey of 196 patients with congenital central hypoventilation syndrome. Pediatr Pulmonol. 2004 Mar;37(3):217-29. doi: 10.1002/ppul.10438.

    PMID: 14966815BACKGROUND

  • Uong EC, Jeffe DB, Gozal D, Arens R, Holbrook CR, Palmer J, Cleveland C, Schotland HM. Development of a measure of knowledge and attitudes about obstructive sleep apnea in children (OSAKA-KIDS). Arch Pediatr Adolesc Med. 2005 Feb;159(2):181-6. doi: 10.1001/archpedi.159.2.181.

    PMID: 15699313BACKGROUND

  • Tauman R, O'Brien LM, Ivanenko A, Gozal D. Obesity rather than severity of sleep-disordered breathing as the major determinant of insulin resistance and altered lipidemia in snoring children. Pediatrics. 2005 Jul;116(1):e66-73. doi: 10.1542/peds.2004-2527.

    PMID: 15995020BACKGROUND

MeSH Terms

Conditions

Lung DiseasesSleep Apnea SyndromesNeurologic Manifestations

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Gozal

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2000

First Posted

October 3, 2000

Study Start

September 1, 1999

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

April 10, 2017

Record last verified: 2017-04