Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Danielle Friberg, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01676181
First received: August 21, 2012
Last updated: December 12, 2014
Last verified: December 2014

August 21, 2012
December 12, 2014
November 2011
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01676181 on ClinicalTrials.gov Archive Site
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
Same as current
  • 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
Same as current
 
ATT Compared With ATE in OSAS Children
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Obstructive Sleep Apnea Syndrome in Children
  • Procedure: Adenotonsillectomy
    Total removal of tonsils and adenoid tissue with cold-steel
  • Procedure: Adenotonsillotomy
    Partial removal of tonsils with coblation and total removal of adenoids with cold steel
  • Active Comparator: Adenotonsillectomy
    Total removal of tonsils and adenoids with cold steel
    Intervention: Procedure: Adenotonsillectomy
  • Active Comparator: Adenotonsillotomy
    Partial removal of tonsils with coblation and total removal of adenoids with cold steel
    Intervention: Procedure: Adenotonsillotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
August 2022
August 2014   (final data collection date for primary outcome measure)

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
Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01676181
2011/333-31/4
Yes
Danielle Friberg, Karolinska University Hospital
Karolinska University Hospital
Not Provided
Principal Investigator: Danielle Friberg, MD, PhD Karolinska University Hospital, ORL dep
Karolinska University Hospital
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP