Behavioral Effects of Obstructive Sleep Apnea in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-08-31

Study Completion Date

2004-01-31

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.

Conditions

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Sleep-disordered Breathing Sleep Apnea, Obstructive ADHD

Keywords

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Polysomnography Sleep-disordered breathing Sleep apnea, obstructive Hyperactivity Sleep Child

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adenotonsillectomy group

Children ages 5-12 who are scheduled for adenotonsillectomy for obstructive sleep apnea

No interventions assigned to this group

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.

No interventions assigned to this group

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

* 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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Ronald D. Chervin, M.D., M.S.

Michael S Aldrich Collegiate Professor of Sleep Medicine and Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald D Chervin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Univerisity of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

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5R01HD038461

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01HD38461-3

Identifier Type: -

Identifier Source: org_study_id

Behavioral Effects of Obstructive Sleep Apnea in Children

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Adenotonsillectomy group

Comparison group

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

University of Michigan

Responsible Party

Ronald D. Chervin, M.D., M.S.

Principal Investigators

Ronald D Chervin, MD, MS

Locations

Univerisity of Michigan Health System

Countries

References

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. doi: 10.1016/s1389-9457(03)00100-x.

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. doi: 10.1093/sleep/26.8.1022.

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. doi: 10.1177/1099800403260261.

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. doi: 10.1093/sleep/27.1.110.

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. doi: 10.1093/sleep/27.1.116.

Giordani B, Hodges EK, Guire KE, Ruzicka DL, Dillon JE, Weatherly RA, Garetz SL, Chervin RD. Neuropsychological and behavioral functioning in children with and without obstructive sleep apnea referred for tonsillectomy. J Int Neuropsychol Soc. 2008 Jul;14(4):571-81. doi: 10.1017/S1355617708080776.

Chervin RD, Weatherly RA, Garetz SL, Ruzicka DL, Giordani BJ, Hodges EK, Dillon JE, Guire KE. Pediatric sleep questionnaire: prediction of sleep apnea and outcomes. Arch Otolaryngol Head Neck Surg. 2007 Mar;133(3):216-22. doi: 10.1001/archotol.133.3.216.

Chervin RD, Weatherly RA, Ruzicka DL, Burns JW, Giordani BJ, Dillon JE, Marcus CL, Garetz SL, Hoban TF, Guire KE. Subjective sleepiness and polysomnographic correlates in children scheduled for adenotonsillectomy vs other surgical care. Sleep. 2006 Apr;29(4):495-503.

Chervin RD, Ruzicka DL, Giordani BJ, Weatherly RA, Dillon JE, Hodges EK, Marcus CL, Guire KE. Sleep-disordered breathing, behavior, and cognition in children before and after adenotonsillectomy. Pediatrics. 2006 Apr;117(4):e769-78. doi: 10.1542/peds.2005-1837.

Other Identifiers

5R01HD038461

5R01HD38461-3