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Obesity and Obstructive Sleep Apnea (OSA) in Children

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ClinicalTrials.gov Identifier: NCT01135147
Recruitment Status : Unknown
Verified May 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2010
Last Update Posted : June 2, 2010
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Obesity Behavioral: Diet Procedure: Surgery

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Therapy for Obesity-related Sleep-disordered Breathing in Children
Study Start Date : June 2010
Estimated Primary Completion Date : June 2012

Arm Intervention/treatment
Experimental: Diet
Patients treated with diet and physical therapy for the entire 6 months of the study
Behavioral: Diet
Dietary therapy and physical education
Active Comparator: Surgery
Patients undergoing adenotonsillectomy at some point of the study period
Procedure: Surgery
Adenotonsillectomy along with diet and physical therapy



Primary Outcome Measures :
  1. Reduction in apnea hypopnea index (AHI) [ Time Frame: 3, 6 months ]
    Repeat polysomnography to assess change in AHI following treatment


Secondary Outcome Measures :
  1. Change in subjective complaints and sleepiness [ Time Frame: 6 months ]
  2. Change in lipid profile and liver enzymes [ Time Frame: 6 months ]


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135147


Contacts
Contact: Arnon Elizur, MD 972-8-977-9817 arnone@asaf.health.gov.il

Locations
Israel
Asaf Harofeh Medical Center Not yet recruiting
Zerifin, Israel, 70300
Contact: Arnon Elizur, MD    972-8-9779817    arnone@asaf.health.gov.il   
Principal Investigator: Arnon Elizur, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Responsible Party: Arnon Elizur, MD, Assaf Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01135147     History of Changes
Other Study ID Numbers: 40/09
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: June 2, 2010
Last Verified: May 2010

Additional relevant MeSH terms:
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases