Obstructive Sleep Apnea in Obese Children and Teenagers - Occurrence and Importance of Intervention
1 other identifier
observational
236
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedDecember 13, 2018
December 1, 2018
2.8 years
June 2, 2015
December 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in obstructive sleep apnea (OSA)
OSA will be diagnosed by cardiorespiratory measurement. The examination will be repeated after weight loss.
One year
Study Arms (1)
Obese children and adolescents
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.
Interventions
Eligibility Criteria
The cohort consists of children attending the Childrens Obesity Clinic in Holbaek.
You may qualify if:
- Age: 7-18 years
- BMI \> 90th percentile for age and gender
You may not qualify if:
- Neuromuscular disorders
- Craniofacial syndromes / malformations
- Laryngeal and tracheal malformations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zealand University Hospitallead
- Holbaek Sygehuscollaborator
Study Sites (2)
Holbaek Sygehus
Holbæk, Danmark, 4300, Denmark
Zealand University Hospital
Køge, Danmark, 4600, Denmark
Related Publications (1)
Orntoft M, Andersen IG, Homoe P. Agreement between manual and automatic analyses of home sleep examinations in pediatric obstructive sleep apnea. J Comp Eff Res. 2019 Jun;8(8):623-631. doi: 10.2217/cer-2018-0093. Epub 2019 May 24.
PMID: 31122047DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ida Andersen, MD
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 4, 2015
Study Start
April 1, 2015
Primary Completion
February 1, 2018
Study Completion
June 1, 2018
Last Updated
December 13, 2018
Record last verified: 2018-12