Behavioral Effects of Obstructive Sleep Apnea in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Behavioral Effect of Obstructive Sleep Apnea in Children

Conditions
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Sleep-disordered Breathing, Sleep Apnea, Obstructive, ADHD

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adenotonsillectomy group<br>Children ages 5-12 who are scheduled for adenotonsillectomy for obstructive sleep apnea | |
| Comparison group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polysomnography, Sleep-disordered breathing, Sleep apnea, obstructive, Hyperactivity, Sleep, Child