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Behavioral Effects of Obstructive Sleep Apnea in Children - Article


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Clinical Trial: Behavioral Effects of Obstructive Sleep Apnea in Children

This study is no longer recruiting patients.

Sponsors and Collaborators: National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

Sleep-disordered breathing (SDB) in children may be responsible for disruptive daytime behaviors such as inattention and hyperactivity. Many children undergo tonsillectomy for SDB and disruptive daytime behaviors. However, the link between SDB and disruptive behavior is not clearly understood. This study will evaluate the relationship between SDB and disruptive behavior.

Condition
Sleep-Disordered Breathing
Sleep Apnea, Obstructive
ADHD

MedlinePlus related topics:  Attention Deficit Disorder with Hyperactivity;   Sleep Apnea

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study

Official Title: Behavioral Effect of Obstructive Sleep Apnea in Children

Further Study Details: 

Expected Total Enrollment:  106

Study start: August 1999;  Study completion: July 2005
Last follow-up: January 2004;  Data entry closure: January 2004

While adenotonsillectomy (AT) remains one of the most common surgical procedures performed in children, indications for AT have changed in recent years. Surgeons now perform AT for suspected obstructive SDB and for daytime behaviors that may be a consequence of SDB, such as inattention and hyperactivity. However, whether SDB causes these and other disruptive behaviors is not well known. Further, the precise nature of these behaviors and what types or levels of SDB may be of concern are poorly understood. Consequently, pediatricians and otolaryngologists are not able to use objective preoperative testing to assess SDB and abnormal behavior.

This research project seeks to better define the relationship between childhood SDB and daytime behavioral problems and to determine whether SDB actually causes these behaviors. The study will better define whether inattention and hyperactivity are frequent among children who undergo AT, will identify measures and levels of SDB that are indicative of these behaviors, and will test whether improvement in SDB after AT is associated with improvement in behavior.

Five- to twelve-year-old children who have been scheduled for AT or for a control group procedure (minimally invasive, non-airway-related surgeries such as herniorraphies) will undergo behavioral assessments, cognitive tests, and structured psychiatric interviews. A secondary control group will include healthy children who are not scheduled for any type of surgery. Preoperative assessments will be used to define what behaviors are more prominent in the children scheduled for AT than in children scheduled for hernia repair. All children will undergo preoperative polysomnography to detect subtle forms of SDB that may be particularly prevalent in children. Children will also undergo assessments after surgery.

Children will be scheduled for two or three study visits, depending on whether participants agreed to an optional 3-month interim assessment. Children will be followed for approximately 1 year from the date of surgery.

Eligibility

Ages Eligible for Study:  5 Years   -   12 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria

  • Scheduled for adenotonsillectomy at participating local otolaryngology practices

Exclusion Criteria

  • Serious health conditions that make interpretation of sleep studies or cognitive testing difficult
  • Mental or physical handicaps that prevent proper interpretation of behavioral tests
  • Current treatment by a physician for SDB
  • Previous surgeries for SDB, such as adenoidectomy and/or tonsillectomy or other airway-related surgeries
  • Inability to schedule sleep and behavioral testing prior to surgery
  • Requires sleep or behavioral testing for clinical indications
  • Planning to schedule additional surgeries within 1 year of study entry
  • Unreliable or inconvenient access to the University of Michigan facilities within 1 year of study entry

Additional Exclusion Criteria for Control Group

  • History of large, uninfected tonsils
  • History of recurrent throat infections ( > 7 infections in one year, > 5 infections in each of two years, or > 3 infections in each of 3 years)
  • History of adenoidectomy, tonsillectomy, or other treatment for SDB
  • Planned adenoidectomy and/or tonsillectomy

Location Information


Michigan
      University of Michigan, Ann Arbor,  Michigan,  48019,  United States

Study chairs or principal investigators

Ronald D Chervin, MD, MS,  Principal Investigator,  University of Michigan   

More Information

Publications

Weatherly RA, Mai EF, Ruzicka DL, Chervin RD. Identification and evaluation of obstructive sleep apnea prior to adenotonsillectomy in children: a survey of practice patterns. Sleep Med. 2003 Jul;4(4):297-307.

Chervin RD, Ruzicka DL, Wiebelhaus JL, Hegeman GL 3rd, Marriott DJ, Marcus CL, Giordani BJ, Weatherly RA, Dillon JE. Tolerance of esophageal pressure monitoring during polysomnography in children. Sleep. 2003 Dec 15;26(8):1022-6.

Archbold KH, Giordani B, Ruzicka DL, Chervin RD. Cognitive executive dysfunction in children with mild sleep-disordered breathing. Biol Res Nurs. 2004 Jan;5(3):168-76.

Chervin RD, Burns JW, Subotic NS, Roussi C, Thelen B, Ruzicka DL. Method for detection of respiratory cycle-related EEG changes in sleep-disordered breathing. Sleep. 2004 Feb 1;27(1):110-5.

Chervin RD, Burns JW, Subotic NS, Roussi C, Thelen B, Ruzicka DL. Correlates of respiratory cycle-related EEG changes in children with sleep-disordered breathing. Sleep. 2004 Feb 1;27(1):116-21.

Study ID Numbers:  5R01HD38461-3
Record last reviewed:  October 2004
Last Updated:  October 19, 2004
Record first received:  May 9, 2003
ClinicalTrials.gov Identifier:  NCT00060723
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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