Impact of Treatment of Mild Sleep-Disordered Breathing on Children's Health

Status: Completed
Location: See all (7) locations...
Intervention Type: Procedure, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to evaluate the effects of early adenotonsillectomy (eAT) on the behavior, sleep-disordered breathing symptoms and quality of life for children who snore, but do not have obstructive sleep apnea, as well as identify factors that moderate responses to the surgery. Half of participants will receive eAT, while the other half will be observed with watchful waiting and supportive care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: f
View:

• Diagnosis of mild sleep-disordered breathing (MSDB) defined as meeting all of the following criteria:

‣ Caregiver report of habitual snoring that occurs most of the night on at least three nights per week, and has been present for at least three months (on average occurring \> 3 nights per week or more half of sleep time) and

⁃ Centrally-scored polysomnogram (PSG) confirming an obstructive apnea index (OAI) \<1/hour and apnea-hypopnea index (AHI) ≤3/hour and no oxygen saturation (SpO2) desaturation \< 90% in conjunction with obstructive events, confirmed on PSG.

• Tonsillar hypertrophy ≥2 based on a standardized scale of 0-4.

• Deemed to be a candidate for AT by otolaryngologist (ENT) evaluation (i.e., no technical issues that would be a contraindication for surgery such as submucous cleft palate.)

• Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications).

Locations
United States
Massachusetts
Boston Children's Hospital
Boston
Michigan
University of Michigan Health System
Ann Arbor
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
University Hospitals-Case Medical Center
Cleveland
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Texas
University of Texas Southwestern Medical Center
Dallas
Virginia
Children's Hospital of the King's Daughters
Norfolk
Time Frame
Start Date: 2017-06-06
Completion Date: 2022-02-28
Participants
Target number of participants: 459
Treatments
Active_comparator: Watchful Waiting with Supportive Care
All Watchful Waiting with Supportive Care (WWSC) participants will receive information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
Experimental: Early Adenotonsillectomy
All Early Adenotonsillectomy (eAT) participants will receive information about healthy sleep habits for children, undergo adenotonsillectomy within 4 weeks of randomization and receive appropriate clinical referrals for management of co-morbidities
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: University of Rochester, Boston Children's Hospital, University of Michigan, Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Children's Hospital of The King's Daughters, University Hospitals Cleveland Medical Center, University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov

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