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Completed

NCT Number: NCT01676181

ATT Compared With ATE in OSAS Children

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

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital, ORL dep

Stockholm, 141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adenotonsillectomy

Procedure

Total removal of tonsils and adenoid tissue with cold-steel

Adenotonsillotomy

Procedure

Partial removal of tonsils with coblation and total removal of adenoids with cold steel

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. Per- and postoperative bleeding

    Time frame: One year

    The two groups (ATT and ATE) will be compared concerning per- and postoperative bleeding.

  2. 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.

  3. 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.

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Acronym: RCT ATE/ATT

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Aug 30, 2012
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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