Obesity and Obstructive Sleep Apnea (OSA) in Children
Primary Purpose
Obstructive Sleep Apnea, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Diet
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- BMI at or above the 90th percentile
Exclusion Criteria:
- children with chronic lung or liver disease, mental retardation, syndromes (i.e. prader willi syndrome), endocrine abnormalities (hypothyroidism cushing), chronic medical treatment with oral steroids, or with anti-psychiatric or anti-convulsive medications
Sites / Locations
- Asaf Harofeh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Diet
Surgery
Arm Description
Patients treated with diet and physical therapy for the entire 6 months of the study
Patients undergoing adenotonsillectomy at some point of the study period
Outcomes
Primary Outcome Measures
Reduction in apnea hypopnea index (AHI)
Repeat polysomnography to assess change in AHI following treatment
Secondary Outcome Measures
Change in subjective complaints and sleepiness
Change in lipid profile and liver enzymes
Full Information
NCT ID
NCT01135147
First Posted
May 31, 2010
Last Updated
June 1, 2010
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01135147
Brief Title
Obesity and Obstructive Sleep Apnea (OSA) in Children
Official Title
Dietary Therapy for Obesity-related Sleep-disordered Breathing in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this research is to study the prevalence of sleep disordered breathing and associated morbidity in obese children and to examine the role of diet and physical activity in the treatment of sleep-disordered breathing in obese children.
Detailed Description
In a prospective cohort study, obese children will be recruited. After informed consent is obtained, all children will complete a standardized sleep questionnaire and a pediatric daily sleepiness scale questionnaire. All participants will undergo a complete physical examination, blood tests for lipid profile, liver enzymes, and Glucose and insulin will be obtained, and liver sonography will be performed to assess for the presence of fatty liver. Nasopharyngeal radiographs will be used to assess adenoidal size based on the method by Cohen and Konak. A standard in-laboratory, overnight polysomnography will be performed, within 2 weeks of enrollment to the study, in the sleep laboratory at Asaf Harofeh Medical Center. Children with severe obstructive sleep apnea, defined as apnea hypopnea index (AHI) > 15 will undergo adenotonsillectomy. All children will be referred for a dietary and physical education program. The first visit with the dietician will be considered day 1 of the study. Children will than be followed monthly by a dietician. After three months of follow-up, subjects will be divided into two groups. Group 1 will include all children who had AHI > 2 on the initial polysomnography (including children who underwent adenotonsillectomy for AHI > 15), and group 2 will consist of children who had AHI < 2 on the initial PSG. Children of group 2 will continue monthly dietary visits as before. Children from group 1 will undergo a second evaluation including questionnaires, laboratory blood tests, liver sonography, nasopharyngeal radiographs, and polysomnography. Children who demonstrate reduction in the AHI based on PSG will be offered to continue with dietary treatment alone. Children with no change in the AHI based on PSG will be offered to undergo adenotonsillectomy in addition to continued dietary management. All children will be followed for a total duration of six months. After six months, all children will be re-evaluated by questionnaires, blood tests, liver sonography, and nasopharyngeal radiographs. Polysomnography will be performed in all children who had an AHI > 2 on the second PSG.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet
Arm Type
Experimental
Arm Description
Patients treated with diet and physical therapy for the entire 6 months of the study
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Patients undergoing adenotonsillectomy at some point of the study period
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Dietary therapy and physical education
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Adenotonsillectomy along with diet and physical therapy
Primary Outcome Measure Information:
Title
Reduction in apnea hypopnea index (AHI)
Description
Repeat polysomnography to assess change in AHI following treatment
Time Frame
3, 6 months
Secondary Outcome Measure Information:
Title
Change in subjective complaints and sleepiness
Time Frame
6 months
Title
Change in lipid profile and liver enzymes
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI at or above the 90th percentile
Exclusion Criteria:
children with chronic lung or liver disease, mental retardation, syndromes (i.e. prader willi syndrome), endocrine abnormalities (hypothyroidism cushing), chronic medical treatment with oral steroids, or with anti-psychiatric or anti-convulsive medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnon Elizur, MD
Phone
972-8-977-9817
Email
arnone@asaf.health.gov.il
Facility Information:
Facility Name
Asaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnon Elizur, MD
Phone
972-8-9779817
Email
arnone@asaf.health.gov.il
First Name & Middle Initial & Last Name & Degree
Arnon Elizur, MD
12. IPD Sharing Statement
Learn more about this trial
Obesity and Obstructive Sleep Apnea (OSA) in Children
We'll reach out to this number within 24 hrs