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Completed

NCT Number: NCT02463201

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

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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Holbaek Sygehus, Holbæk, Danmark, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Weight Loss

Behavioral

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Holbaek Sygehus

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2015
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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