Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060723
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2003-05-09
Brief Title:
Behavioral Effects of Obstructive Sleep Apnea in Children
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Behavioral Effect of Obstructive Sleep Apnea in Children
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None