Childhood Adenotonsillectomy Study for Children With OSAS (CHAT)

November 10, 2015 updated by: University of Pennsylvania

A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

453

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Cardinal Glennon Children's Medical Center
    • New York
      • New York, New York, United States, 10467
        • Montefiore Children's Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies & Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19401
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • EAT
Other: 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 Names:
  • Watchful Waiting with Supportive Care (WWSC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
The primary endpoint measure will occur at 7 months following the baseline visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months
Time Frame: 7 months following the baseline visit.
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.
7 months following the baseline visit.
Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale
Time Frame: 7 months following baseline.
Scores on the Pediatric Sleep Questionnaire sleep-related breathing disorder scale (PSQ-SRBD) range from 0 to 1, with higher scores indicating greater severity.
7 months following baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Harvard University

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 19, 2007

First Submitted That Met QC Criteria

November 19, 2007

First Posted (Estimate)

November 20, 2007

Study Record Updates

Last Update Posted (Estimate)

December 15, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 804695
  • 5U01HL083129-05 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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