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

NCT ID: NCT02463201

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Sleep Apnea, Obstructive Pediatric Obesity

Keywords

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Sleep Apnea, Obstructive Pediatric Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Weight loss

Intervention Type BEHAVIORAL

Interventions

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Weight loss

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Neuromuscular disorders
* Craniofacial syndromes / malformations
* Laryngeal and tracheal malformations
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Holbaek Sygehus

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ida Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Holbaek Sygehus

Holbæk, Danmark, Denmark

Site Status

Zealand University Hospital

Køge, Danmark, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31122047 (View on PubMed)

Other Identifiers

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SJ-404

Identifier Type: -

Identifier Source: org_study_id