NCT01135147

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Last Updated

June 2, 2010

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

May 31, 2010

Last Update Submit

June 1, 2010

Conditions

Obstructive Sleep ApneaObesity

Outcome Measures

Primary Outcomes (1)

  • Reduction in apnea hypopnea index (AHI)

    Repeat polysomnography to assess change in AHI following treatment

    3, 6 months

Secondary Outcomes (2)

  • Change in subjective complaints and sleepiness

    6 months

  • Change in lipid profile and liver enzymes

    6 months

Study Arms (2)

Diet

EXPERIMENTAL

Patients treated with diet and physical therapy for the entire 6 months of the study

Behavioral: Diet

Surgery

ACTIVE COMPARATOR

Patients undergoing adenotonsillectomy at some point of the study period

Procedure: Surgery

Interventions

DietBEHAVIORAL

Dietary therapy and physical education

Diet
SurgeryPROCEDURE

Adenotonsillectomy along with diet and physical therapy

Surgery

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • BMI at or above the 90th percentile

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesity

Interventions

DietSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Arnon Elizur, MD

CONTACT

972-8-977-9817arnone@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 31, 2010

First Posted

June 2, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Last Updated

June 2, 2010

Record last verified: 2010-05

Locations

IL(1)