Randomized Control Trials of Surgery for Pediatric OSA

April 4, 2019 updated by: Danielle Friberg, Karolinska University Hospital

Randomized Controlled Studies of Sugery for Pediatric OSA: Part 1 Expectancy Compared to Adeno-tonsillectomy for Mild-moderate OSA. Part 2 Adeno-tonsillectomy Compared to Adeno-pharyngoplasty for Severe OSA.

Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the family is asked to be in the study. If yes, the doctor take a sealed envelope and open it, either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether PSG shows b) severe OSA and the family accept participation the child is operated within a month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2) above 30. A sealed envelope is open in the operating room by the surgeon. The child is randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded for the family, who will not know which method the child has undergone. After 6 months all children will undergo follow-up with PSG and questionnaires. If the expectancy group will deteriorate during waiting time, or the child still has moderate to severe OSA, they will undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be evaluated with two PSG, 80 in each group.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

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

  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital

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

Description

Inclusion Criteria:

  • OAHI >= 2
  • Tonsillary hypertrophy, Brodsky size 2-4
  • Adequate swedish knowledge

Exclusion Criteria:

  • Cardiovascular disorders
  • Pulmonary disorders
  • Neuromuscular disorders
  • Cranoifacial malformations
  • Genetic disorders
  • Earlier performed adenoid-tonsillary-surgery
  • Bleeding disorders

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: expectancy for mild-moderate OSA
6 months expectancy
Experimental: ATE for mild-moderate OSA
adeno-tonsillectomy
Procedure: ATE
surgical removal of adenoids and tonsils
Other Names:
  • adeno-tonsillectomy
Experimental: ATE for severe OSA
adeno-tonsillectomy
Procedure: ATE
surgical removal of adenoids and tonsils
Other Names:
  • adeno-tonsillectomy
Experimental: APP for severe OSA
adeno-pharyngoplasty
Procedure: APP
surgical removal of adenoids and tonsils and suturing of palatal pillars
Other Names:
  • adeno-pharyngoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
obstructive apnea hypopnea index
Time Frame: 6 months
with full-night polysomnography
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygen desaturation index
Time Frame: 6 months
with full-night polysomnography
6 months
postoperative pain
Time Frame: 6 months
visuell analog scale, questionnaire diaries. Number of days until normal diet.
6 months
per- and postoperative bleeding
Time Frame: postoperatively, weeks
description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively
postoperatively, weeks
quality of life
Time Frame: 6 months
Questionnaires validated, SDQ and OSA-18
6 months
Innate lymphoid cells in tonsils
Time Frame: 6 months
To investigate the amount of Innate lymphoid cells in children with OSA
6 months
side-effects of surgery
Time Frame: 6 months
with a questionnaire evaluate if the child postoperatively will have speech-or swallowing difficulties. The parents will respond with a four-point Likert scale
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
longterm results
Time Frame: 3 years
with new polysomnography and questionnaires. Evaluate number of patients that are cured, AHI below 2.
3 years
longterm results
Time Frame: 10 years
with new polysomnography and questionnaires.Evaluate number of patients that are cured, AHI below 2.
10 years

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Investigators

  • Study Director: Bo Tideholm, ENT-clinic, Karolinska University 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

December 1, 2014

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT02315911

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.

Clinical Trials on Sleep Apnea, Obstructive

Clinical Trials on ATE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe