Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Childhood Adenotonsillectomy Study for Children With OSAS (CHAT)

This study has been completed.
Sponsor:
Collaborators:
Harvard University
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00560859
First received: November 19, 2007
Last updated: November 10, 2015
Last verified: November 2015
  Purpose
The purpose of this research is to determine the effect of adenotonsillectomy surgery (removal of tonsils and adenoids) on obstructive sleep apnea syndrome (OSAS) in children. OSAS can cause health problems including poor growth, high blood pressure, diabetes and behavioral and learning difficulties. Although adenotonsillectomy is the usual treatment for children with OSAS, it is not known with any certainty if the child's OSAS symptoms improve afterwards. This study will help determine if improvement occurs or if it does not. It will also look at whether certain groups, such as children who are overweight or of different ethnicities, are helped by the surgery.

Condition Intervention
Obstructive Sleep Apnea
Snoring
Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils
Other: Watchful Waiting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months. [ Time Frame: The primary endpoint measure will occur at 7 months following the baseline visit. ] [ Designated as safety issue: No ]
    The primary outcome was the change in the attention and executive function score on the NEPSY. The change from baseline in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) was compared to 7 months were compared. Scores on the attention and executive-function domain of the Developmental Neuropsychological Assessment (NEPSY) range from 50 to 150, with higher scores indicating better functioning.


Secondary Outcome Measures:
  • Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months [ Time Frame: 7 months following the baseline visit. ] [ Designated as safety issue: No ]
    The outcome measure was the change in AHI from baseline to 7 months to determine if there was an improvement in score is associated with improved OSAS (i.e reduction in AHI). The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The obstructive sleep apnea syndrome was defined as an AHI score of 2 or more events per hour or an obstructive apnea index (OAI) score of 1 or more events per hour.

  • Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale [ Time Frame: 7 months following baseline. ] [ Designated as safety issue: No ]
    Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.


Enrollment: 453
Study Start Date: October 2007
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early AT Surgery
There will be removal of tonsils and adenoids that will be performed within 4 weeks of the baseline visit.
Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils
Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome which includes removal of adenoids and tonsils
Other Name: EAT
Watchful Waiting
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
Other: Watchful Waiting
Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
Other Name: Watchful Waiting with Supportive Care (WWSC)

Detailed Description:

Because adenotonsillectomy is the usual treatment for OSAS, all children in the study will get surgery. However, in order to assess the extent to which adenotonsillectomy surgery improves breathing disturbances and sleep quality in children with OSAS, two groups will be studied. One group will get surgery early (one month after enrollment) and the other group will be re-evaluated for surgery within 7 months of enrollment.

Children in both groups will be closely monitored through the 7-8 month study period and sleep and health educational materials will be provided to assist in establishing healthy habits.

  Eligibility

Ages Eligible for Study:   5 Years to 9 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages 5.0 to 9.99 years at time of screening.
  2. Diagnosed with Obstructive Sleep Apnea defined as: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 2, confirmed on nocturnal, laboratory-based PSG and Parental report of habitual snoring (on average occurring >3 nights per week).
  3. Tonsillar hypertrophy ≥ 1 based on a standardized scale of 0-4: 0 = surgically absent, 1 = taking up < 25% of the airway, 2 = 25 - 50 % of the airway,3 = 50 - 75 % of the airway, 4 = > 75% of the airway
  4. Deemed to be a surgical candidate for AT by Ear, Nose and Throat specialist (ENT) evaluation.

Exclusion Criteria:

  1. Recurrent tonsillitis defined as: >3 episodes in each of 3 years, 5 episodes in each of 2 years, or 7 episodes in one year
  2. Craniofacial anomalies, including cleft lip and palate or sub-mucosal cleft palate or any anatomic or systemic condition which would interfere with general anesthesia or removal of tonsils and adenoid tissue in the standard fashion
  3. Obstructive breathing while awake that merits prompt AT in the opinion of the child's physician
  4. Severe OSAS or significant hypoxemia requiring immediate AT as defined by: OAI>20 or AHI>30, desaturation defined as oxygen saturation (SaO2) <90% for more than 2% sleep time
  5. Apnea hypopnea indices in the normal range (OAI < 1 and AHI <2)
  6. Evidence of clinically significant cardiac arrhythmia on PSG: Non-sustained ventricular tachycardia Atrial fibrillation, Second degree atrioventricular (AV) block: Sustained bradycardia < 40 bpm (> 2 minutes, Sustained tachycardia > 140 bpm (> 2 minutes)
  7. Extremely overweight defined as: body mass index > 2.99 age group and sex-z-score
  8. Severe health problems that could be exacerbated by delayed treatment for OSAS Including: Doctor-diagnosed heart disease or cor pulmonale, history of Stage II Hypertension (HTN) defined as > 99% percentile plus 5 mmHg for either systolic or diastolic, based on the age, gender, and height and/or requiring medication, therapy for failure to thrive or short stature, psychiatric or behavioral disorders requiring or likely to require initiation of new medication, therapy, or other specific treatment. School aged children, parental report of excessive daytime sleepiness defined as unable to maintain wakefulness, at least three times per week, in routine activities in school or home, despite adequate opportunity to sleep.
  9. Severe chronic health conditions that might hamper participation including: severe cardiopulmonary disorders, sickle cell anemia, poorly controlled asthma, epilepsy requiring medication, diabetes (type I or type II) requiring medication, conditions likely to preclude accurate polysomnography (e.g. severe uncontrolled pain),mental retardation or enrollment in a formal school Individual Educational Plan (IEP) and assigned to a self-contained classroom for all academic subjects, history of inability to complete cognitive testing and/or score on the Differential Ability Scale (DAS) II of ≤ 55, chronic infection or HIV
  10. Known genetic, craniofacial, neurological or psychiatric conditions likely to affect the airway, cognition, or behavior
  11. Current use of one or more of the following medications: psychotropics, hypnotics,hypoglycemic agents or insulin,antihypertensives,growth hormone, anticonvulsants,anti-coagulants,daily oral corticosteroids, daily medications for pain
  12. Previous upper airway surgery on the nose, pharynx or larynx, including tonsillectomy. Ear surgery and/or pressure equalizing (PE) tubes are not exclusion criteria
  13. Receives Continuous Positive Airway Pressure (CPAP) treatment
  14. A parent or guardian who cannot accompany the child on the night of polysomnogram (PSG)
  15. A family planning to move out of the area within the year
  16. Female participants only: Parental report that child has reached menarche
  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: NCT00560859

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
Cardinal Glennon Children's Medical Center
St. Louis, Missouri, United States, 63110
United States, New York
Montefiore Children's Hospital
New York, New York, United States, 10467
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19401
Sponsors and Collaborators
University of Pennsylvania
Harvard University
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Susan Redline, MD, MPH Harvard University
Study Director: Susan Ellenberg, Ph.D. University of Pennsylvania
Principal Investigator: Ron Chervin, MD, MS University of Michigan
Study Director: Bruno Giordani, PH.D. Univeristy of Michigan
Study Director: Susan Garetz, MD University of Michigan
Principal Investigator: Raouf Amin, MD Cincinnati Children's Hopsital Medical Center (CCHMC)
Principal Investigator: Carole Marcus, MBB Ch. Children's Hospital of Philadelphia
Principal Investigator: Carol Rosen, MD Case University School of Medicine; Rainbow Babies & Children's Hospital
Principal Investigator: Ron Mitchell, MD Cardinal Glennon Children's Medical Center, St. Louis MO
Principal Investigator: Raanan Arens, MD Montefiore Children's Hospital Albert Einstein Med Ctr, NY NY
Principal Investigator: Hiren Muzumdar, MD Montefiore Chilren's Hospital Albert Einstein Med Ctr, NY NY
Principal Investigator: Eliot Katz, MD Boston Children's Hospital, Boston MA
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00560859     History of Changes
Other Study ID Numbers: 804695  5U01HL083129-05 
Study First Received: November 19, 2007
Results First Received: July 13, 2015
Last Updated: November 10, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Sleep disordered breathing
Sleep apnea
Tonsillectomy
Adenoidectomy
Snoring
Neurobehavioral Manifestations
Obstructive Sleep Apnea Syndrome

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

ClinicalTrials.gov processed this record on December 08, 2016