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Sponsors and Collaborators: |
University of Pennsylvania Case Western Reserve University University of Michigan National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00560859 |
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 |
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Obstructive Sleep Apnea Snoring |
Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils Other: Watchful Waiting |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Study of Adenotonsillectomy for Children With Obstructive Sleep Apnea Syndrome |
Estimated Enrollment: | 460 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | January 2010 |
Arms | Assigned Interventions |
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Early AT Surgery: Active Comparator
Children will be closely monitored and receive adenotonsillectomy (AT) within 4 weeks of the baseline visit.
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Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils
Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.
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Watchful Waiting
Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.
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Other: Watchful Waiting
Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.
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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 throughout the 12 month study period and sleep and health educational materials will be provided to assist in establishing healthy habits.
Ages Eligible for Study: | 5 Years to 9 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Severe OSAS or significant hypoxemia requiring immediate AT as defined by:
OAI > 20 or AHI > 30, Desaturation defined as SaO2 <90% for more than 2% sleep time
Female participants only: Parental report that child has reached menarche.
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United States, Kentucky | |
Kosair Children's Hospital | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Dianna O'Neal, RN 502-852-5303 dconea01@gwise.louisville.edu | |
Principal Investigator: David Gozal, MD | |
Sub-Investigator: Karen Spruyt, Ph.D. | |
Sub-Investigator: Maria Veling, MD | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Contact: Jenny Jeffries 513-636-1052 jenny.jeffries@cchmc.org | |
Contact: Ashley Morgenthal 513-636-9436 ashley.morgenthal@cchmc.org | |
Principal Investigator: Raouf Amin, MD | |
Sub-Investigator: Dean W Beebe, Ph.D. | |
Sub-Investigator: J. Paul Willging, MD | |
Rainbow Babies & Children's Hospital | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Judith Emancipator 216-844-2553 judith.emancipator@case.edu | |
Principal Investigator: Carol Rosen, MD | |
Sub-Investigator: H. Gerry Taylor, Ph.D. | |
Sub-Investigator: Robert Sprecher, MD | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19401 | |
Contact: Laurie Karremensis 267-426-5748 karamessinis@email.chop.edu | |
Contact: Ruth M Bradford 267-426-5747 bradford@email.chop.edu | |
Principal Investigator: Carole Marcus, MBB Ch | |
Sub-Investigator: Nina Hattiangadi-Thomas, Ph.D. | |
Sub-Investigator: Lisa Elden, MD |
Study Chair: | Susan Redline, MD, MPH | Case Western Reserve 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: | David Gozal, MD | University of Louisville; Kosair Children's Hospital |
Principal Investigator: | Carole Marcus, MBB Ch. | Children's Hospital of Philadelphia (CHOP) |
Principal Investigator: | Carol Rosen, MD | Case University School of Medicine; Rainbow Babies & Children's Hospital |
Responsible Party: | Case Western Reserve University ( Susan Redline, MD, MPH ) |
Study ID Numbers: | 804695, 1 R01 HL083129-01A1 |
Study First Received: | November 19, 2007 |
Last Updated: | November 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00560859 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Sleep disordered breathing Sleep apnea Tonsillectomy Adenoidectomy |
Snoring Neurobehavioral Manifestations Obstructive Sleep Apnea Syndrome |
Sleep Apnea Syndromes Respiratory Sounds Apnea Sleep Apnea, Obstructive Respiration Disorders Snoring Sleep Disorders |
Dyssomnias Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory Neurobehavioral Manifestations |
Nervous System Diseases |