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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Danielle Friberg, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01676181
First received: August 21, 2012
Last updated: August 30, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Obstructive Sleep Apnea Syndrome in Children
Procedure: Adenotonsillectomy
Procedure: Adenotonsillotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Surgical Intervention Study Between Adenotonsillectomy and Adenotonsillotomy in Children With Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Changes in polysomnographic parameter AHI (Apnea Hypopnea Index) [ Time Frame: One, three and ten years ] [ Designated as safety issue: No ]
    AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.


Secondary Outcome Measures:
  • Changes in quality of life questionnaires (OSA18 and SDQ) [ Time Frame: One, three and ten Years ] [ Designated as safety issue: No ]
    Parents answering to quality of life-questionnaire OSA18 and SDQ (Strengths and Difficulties Questionnaire) before and after surgical intervention


Other Outcome Measures:
  • Per- and postoperative bleeding [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The two groups (ATT and ATE) will be compared concerning per- and postoperative bleeding.

  • changes in polysomnographic parameters other than AHI [ Time Frame: one, three and ten years ] [ Designated as safety issue: No ]
    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.

  • Differences in postoperative pain [ Time Frame: One year ] [ Designated as safety issue: No ]
    The two groups will be compared with questionnaires and consumption of analgetics concerning the degree of postoperative pain.

  • Number of patients who need reoperations [ Time Frame: One, three and ten years ] [ Designated as safety issue: Yes ]
    The patient may need reoperations, either because of postoperative bleeding or because the tonsils have regrowth

  • Abnormalities in DNA analysis of blood and tonsil tissue [ Time Frame: one year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 70
Study Start Date: November 2011
Estimated Study Completion Date: August 2022
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676181

Contacts
Contact: Anna Borgström, MD +46858580000 anna.borgstrom@karolinska.se
Contact: Danielle Friberg, MD, PhD +46858580000 danielle.friberg@karolinska.se

Locations
Sweden
Karolinska University Hospital, ORL dep Recruiting
Stockholm, Sweden, 141 86
Contact: Anna Borgström, MD       anna.borgstrom@karolinska.se   
Contact: Pia Nerfeldt, MD, PhD    +468 58580000    pia.nerfeldt@karolinska.se   
Principal Investigator: Anna Borgström, MD         
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Danielle Friberg, MD, PhD Karolinska University Hospital, ORL dep
  More Information

No publications provided

Responsible Party: Danielle Friberg, Associate Professor, senior surgeon, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01676181     History of Changes
Other Study ID Numbers: 2011/333-31/4
Study First Received: August 21, 2012
Last Updated: August 30, 2012
Health Authority: Sweden: Karolinska University Hospital, ORL dep

Keywords provided by Karolinska University Hospital:
Obstructive sleep apnea syndrome
Children
Polysomnography
Surgery
Coblation
Tonsils
Tonsillectomy

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014