Trial record 6 of 704 for:    "Sleep Apnea, Obstructive"

Behavioral Effects of Obstructive Sleep Apnea in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ronald D. Chervin, M.D., M.S., University of Michigan
ClinicalTrials.gov Identifier:
NCT00060723
First received: May 9, 2003
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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.


Condition
Sleep-disordered Breathing
Sleep Apnea, Obstructive
ADHD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Behavioral Effect of Obstructive Sleep Apnea in Children

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Enrollment: 106
Study Start Date: August 1999
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adenotonsillectomy group
Children ages 5-12 who are scheduled for adenotonsillectomy for obstructive sleep apnea
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pediatric Otolaryngology surgery practices and primary care or general surgery practices at University of Michigan and St. Joseph Mercy Health Systems

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060723

Locations
United States, Michigan
Univerisity of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Ronald D Chervin, MD, MS University of Michigan
  More Information

Publications:
Responsible Party: Ronald D. Chervin, M.D., M.S., Michael S Aldrich Collegiate Professor of Sleep Medicine and Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT00060723     History of Changes
Other Study ID Numbers: 5R01HD38461-3
Study First Received: May 9, 2003
Last Updated: October 21, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Polysomnography
Sleep-disordered breathing
Sleep apnea, obstructive
Hyperactivity
Sleep
Child

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 26, 2014