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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Notify MeKey information
Conditions
Age range
7 year–18 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Holbaek Sygehus, Holbæk, Danmark, Denmark
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
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.
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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