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Clinical Trials/NCT02463201
NCT02463201
Completed
Not Applicable

Obstructive Sleep Apnea in Obese Children and Teenagers - Occurrence and Importance of Intervention

Zealand University Hospital2 sites in 1 country236 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea, Obstructive
Sponsor
Zealand University Hospital
Enrollment
236
Locations
2
Primary Endpoint
Change in obstructive sleep apnea (OSA)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The prevalence of childhood obesity has increased at an alarming rate over the last decades, both globally and in Denmark. There are a number of serious sequelae related to obesity, such as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to be a risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be associated with cardiovascular complications, neurocognitive problems and reduced quality of life. The correlation between obesity and OSA is still poorly understood. Early detection and intervention is of great importance as the health consequences related to OSA as well as obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with OSA. However, only around 25% of obese children benefit from this treatment compared to around 75% of normal-weight children suggesting that there might be other structural factors predisposing to OSA in obese children.

In this study the investigators aim to clarify the impact of obesity in the development of OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose is to assess the effect of weight loss on OSA.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
June 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age: 7-18 years
  • BMI \> 90th percentile for age and gender

Exclusion Criteria

  • Neuromuscular disorders
  • Craniofacial syndromes / malformations
  • Laryngeal and tracheal malformations

Outcomes

Primary Outcomes

Change in obstructive sleep apnea (OSA)

Time Frame: One year

OSA will be diagnosed by cardiorespiratory measurement. The examination will be repeated after weight loss.

Study Sites (2)

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