Behavioral Effects of Obstructive Sleep Apnea in Children

ADHD Clinical Trial

Official title:

Behavioral Effect of Obstructive Sleep Apnea in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00060723
• Other study ID #: 5R01HD38461-3
• Status: Completed
• Phase: N/A
• First received: May 9, 2003
• Last updated: December 3, 2016
• Start date: August 1999
• Est. completion date: January 2004

Study information

• Verified date: December 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• ADHD
• Apnea
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep-disordered Breathing

Locations

Country	Name	City	State
United States	Univerisity of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Dillon JE, Blunden S, Ruzicka DL, Guire KE, Champine D, Weatherly RA, Hodges EK, Giordani BJ, Chervin RD. DSM-IV diagnoses and obstructive sleep apnea in children before and 1 year after adenotonsillectomy. J Am Acad Child Adolesc Psychiatry. 2007 Nov;46( — View Citation

Giordani B, Hodges EK, Guire KE, Ruzicka DL, Dillon JE, Weatherly RA, Garetz SL, Chervin RD. Changes in neuropsychological and behavioral functioning in children with and without obstructive sleep apnea following Tonsillectomy. J Int Neuropsychol Soc. 201 — View Citation

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 — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references