ATT Compared With ATE in OSAS Children (RCT ATE/ATT)

March 9, 2023 updated by: Danielle Friberg, Karolinska University Hospital

Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome

Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Children with obstructive sleep apnea syndrome (OSAS) have apneas and disturbed sleep, which causes daytime symptoms such as neurobehavioral problems. OSAS is a significant cause of morbidity among children with an incidence of 1-3%, and a peak prevalence at 2-5 years of age. If left untreated it can cause severe complications including failure to thrive, cardiovascular complications, metabolic conditions and neurobehavioral disturbances (eg hyperactivity, inattention).

Golden standard to diagnose OSA in children is full-night polysomnography (PSG) at a sleep laboratory including EEG, EOG, EMG, video-audiometry and respiratory recordings. At the Department of Otorhinolaryngology at Karolinska University Hospital, we have a sleep laboratory performing in-lab full-night polysomnography.

The cause of OSAS in children is usually adenotonsillar hypertrophy, and the treatment of choice is surgical removal of tonsils and adenoid. Traditionally total adenotonsillectomy (ATE) has been performed, but in the last decade an alternative surgical method with partial adenotonsillotomy (ATT) is developed, where only the medial portion of the tonsil is removed. The newer method ATT is not fully evaluated in comparison with traditional ATE. There are studies comparing evaluating post-operative pain and bleeding showing a slight advantage for the TT-method. Very few studies are performed using objectively measured PSG-parameters to evaluate the effect of surgery on the sleep fragmentation and the sleep apneas. There is a need for such studies in the field of surgical treatment of pediatric OSA. This was also stated in a Cochrane database review from 2009, in which the conclusion was that there is a need for high quality randomised controlled trials to be carried out investigating the efficacy of surgical treatment of OSA in children. This makes this study important and of high clinical interest.

Aims: To increase the knowledge of pediatric OSA and its treatment and to optimize the surgical treatment for children with OSA.

To through a blinded randomized controlled trial compare the efficacy of ATT and ATE in treating OSA in children, including long-term follow-up after one, three and ten years.

To evaluate postoperative pain after ATE and ATT. To evaluate quality of life after ATE and ATT.

Study Type

Interventional

Enrollment (Actual)

79

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, 141 86
        • Karolinska University Hospital, ORL dep

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 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 2-6 years
  • Clinical symptoms of OSAS (apneas, snoring, disturbed sleep)
  • Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal space)
  • Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA)

Exclusion Criteria:

  • Clinical signs of craniofacial anomalies or neuromuscular disorders
  • Obesity
  • Earlier having had surgery of tonsils or adenoid
  • Bleeding disorder
  • Cardiopulmonary disorder

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Adenotonsillectomy
Total removal of tonsils and adenoids with cold steel
Procedure: Adenotonsillectomy
Total removal of tonsils and adenoid tissue with cold-steel
Active Comparator: Adenotonsillotomy
Partial removal of tonsils with coblation and total removal of adenoids with cold steel
Procedure: Adenotonsillotomy
Partial removal of tonsils with coblation and total removal of adenoids with cold steel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)
Time Frame: One, three and ten years
AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.
One, three and ten years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quality of life questionnaires (OSA18 and SDQ)
Time Frame: One, three and ten Years
Parents answering to quality of life-questionnaire OSA18 and SDQ (Strengths and Difficulties Questionnaire) before and after surgical intervention
One, three and ten Years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per- and postoperative bleeding
Time Frame: One year
The two groups (ATT and ATE) will be compared concerning per- and postoperative bleeding.
One year
changes in polysomnographic parameters other than AHI
Time Frame: one, three and ten years
Polysomnograhic parameters, for example; the oxygen desaturation index (ODI), lowest oxygen saturation, the respiratory disturbance index (RDI), AHI in REM, total sleep time, time in REM, deep sleep, supine position etc.
one, three and ten years
Differences in postoperative pain
Time Frame: One year
The two groups will be compared with questionnaires and consumption of analgetics concerning the degree of postoperative pain.
One year
Number of patients who need reoperations
Time Frame: One, three and ten years
The patient may need reoperations, either because of postoperative bleeding or because the tonsils have regrowth
One, three and ten years
Abnormalities in DNA analysis of blood and tonsil tissue
Time Frame: one year
Blood and tissue samples will be frozen for future analysis of DNA. We have not yet decided which method we will use. There are other studies suggesting abnormalities in certain enzymes in children with tonsillar hypertrophy
one year

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Danielle Friberg, MD, PhD, Karolinska University Hospital, ORL dep

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

November 1, 2011

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/333-31/4

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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