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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463201
• Other study ID #: SJ-404
• Status: Completed
• Start date: April 2015
• Est. completion date: June 2018

Study information

• Verified date: December 2018
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age: 7-18 years

• BMI > 90th percentile for age and gender

Exclusion Criteria:

• Neuromuscular disorders

• Craniofacial syndromes / malformations

• Laryngeal and tracheal malformations

Related Conditions & MeSH terms

• Apnea
• Pediatric Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Weight loss

Locations

Country	Name	City	State
Denmark	Holbaek Sygehus	Holbaek	Danmark
Denmark	Zealand University Hospital	Køge	Danmark

Sponsors (2)

Lead Sponsor	Collaborator
Zealand University Hospital	Holbaek Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in obstructive sleep apnea (OSA)	OSA will be diagnosed by cardiorespiratory measurement. The examination will be repeated after weight loss.	One year