We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Behavioral Effects of Obstructive Sleep Apnea in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00060723
First Posted: May 13, 2003
Last Update Posted: December 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ronald D. Chervin, M.D., M.S., University of Michigan
May 9, 2003
May 13, 2003
December 6, 2016
August 1999
January 2004   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00060723 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Behavioral Effects of Obstructive Sleep Apnea in Children
Behavioral Effect of Obstructive Sleep Apnea in Children
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Pediatric Otolaryngology surgery practices and primary care or general surgery practices at University of Michigan and St. Joseph Mercy Health Systems
  • Sleep-disordered Breathing
  • Sleep Apnea, Obstructive
  • ADHD
Not Provided
  • Adenotonsillectomy group
    Children ages 5-12 who are scheduled for adenotonsillectomy for obstructive sleep apnea
  • Comparison group
    Children ages 5-12, scheduled for hernia repairs, other procedures not involving the head, chest or neck, or no procedures. Additional exclusions include children with a history of recurrent throat infections, large tonsils, history of or plans for adenoidectomy and/or tonsillectomy or who have been previously diagnosed with sleep-disordered breathing.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
January 2004
January 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 12 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00060723
5R01HD38461-3
No
Not Provided
Not Provided
Ronald D. Chervin, M.D., M.S., University of Michigan
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Ronald D Chervin, MD, MS University of Michigan
University of Michigan
December 2016