Behavioral Effects of Obstructive Sleep Apnea in Children
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|ClinicalTrials.gov Identifier: NCT00060723|
Recruitment Status : Completed
First Posted : May 13, 2003
Last Update Posted : December 6, 2016
|Condition or disease|
|Sleep-disordered Breathing Sleep Apnea, Obstructive ADHD|
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.
|Study Type :||Observational|
|Actual Enrollment :||106 participants|
|Official Title:||Behavioral Effect of Obstructive Sleep Apnea in Children|
|Study Start Date :||August 1999|
|Primary Completion Date :||January 2004|
|Study Completion Date :||January 2004|
Children ages 5-12 who are scheduled for adenotonsillectomy for obstructive sleep apnea
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060723
|United States, Michigan|
|Univerisity of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Ronald D Chervin, MD, MS||University of Michigan|