OSA in Children Referred for Adenotonsillectomy

August 22, 2017 updated by: Lovisenberg Diakonale Hospital

Obstructive Sleep Apnea in Children Referred for Adenotonsillectomy

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0456
        • Recruiting
        • Lovisenberg Diakonale Hospital
        • Contact:
          • Britt Øverland, PhD
          • Phone Number: +4723226326
          • Email: brov@lds.no
        • Contact:
          • Hanne Berdal, MD
          • Phone Number: +4723226381
          • Email: habs@lds.no
        • Principal Investigator:
          • Britt Øverland, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children aged between 2 and 5 years who are referred for adenoidectomy and/or tonsillectomy.

Description

Inclusion Criteria:

  • age 2-5 year
  • referred for adenoidectomy and/or tonsillectomy

Exclusion Criteria:

  • craniofacial anomalies
  • neurological diseases
  • neuropsychiatric diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of OSA
Time Frame: Up to 2 years
Apne hypopne index (AHI)/ respiratory disturbance index (RDI)
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative PSG results
Time Frame: Up to 2 years
Apne hypopne index (AHI)/ respiratory disturbance index (RDI)
Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Up to 2 years
Questionnaire
Up to 2 years
Risk factors of OSA
Time Frame: Up to 2 years
Questionnaire
Up to 2 years
Post operative complications
Time Frame: Up to 2 years
Questionnaire; pulse oximetry
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lovisenberg Diakonale Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

September 5, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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