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

Completed

• Conditions: Pediatric Obesity; Sleep Apnea, Obstructive
• Interventions: Behavioral: Weight loss

• Registration Number: NCT02463201
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Primary Completion: 2018-02
• Study Completion: 2018-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese children and adolescents	Weight loss	Attending a weightloss programme, that consist of lifestyle counseling, dietary restriction and exercise. The prevalence of obstructive sleep apnea (OSA) will be investigated in group. Children diagnosed with OSA will be followed to investigate if weight loss changes the condition.

Primary Outcome Measures

Name	Time	Method
Change in obstructive sleep apnea (OSA)	One year	OSA will be diagnosed by cardiorespiratory measurement. The examination will be repeated after weight loss.

Trial Locations

Locations (2)

Holbaek Sygehus; 🇩🇰 Holbaek, Danmark, Denmark

Zealand University Hospital; 🇩🇰 Køge, Danmark, Denmark