OSA in Children Referred for Adenotonsillectomy
Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy
1 other identifier
observational
115
1 country
1
Brief Summary
In children with OSA (Obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. Studies in recent years have shown that the procedure does not always have the expected effect. Children with OSA are at greater risk for complications from the procedure. There is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an OSA diagnosis. Today less than 10% of these children have polysomnography (PSG). The main purpose of this study is to describe the prevalence of OSA among children referred for adenotonsillectomy. The investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life. The project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with OSA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2014
Typical duration for all trials
1 active site
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
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 13, 2014
CompletedFirst Posted
Study publicly available on registry
September 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 23, 2017
September 1, 2015
3.3 years
August 13, 2014
August 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of OSA
Apne hypopne index (AHI)/ respiratory disturbance index (RDI)
Up to 2 years
Secondary Outcomes (1)
Post operative PSG results
Up to 2 years
Other Outcomes (3)
Quality of life
Up to 2 years
Risk factors of OSA
Up to 2 years
Post operative complications
Up to 2 years
Eligibility Criteria
Children aged between 2 and 5 years who are referred for adenoidectomy and/or tonsillectomy.
You may qualify if:
- age 2-5 year
- referred for adenoidectomy and/or tonsillectomy
You may not qualify if:
- craniofacial anomalies
- neurological diseases
- neuropsychiatric diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lovisenberg Diakonale Hospital
Oslo, 0456, Norway
Related Publications (1)
Overland B, Berdal H, Akre H. Correlations between disease-specific quality of life and polysomnographic findings in children with obstructive sleep apnea. Int J Pediatr Otorhinolaryngol. 2020 Jul;134:110077. doi: 10.1016/j.ijporl.2020.110077. Epub 2020 Apr 30.
PMID: 32402922DERIVED
Biospecimen
Blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2014
First Posted
September 8, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
August 23, 2017
Record last verified: 2015-09