ATT Compared With ATE in OSAS Children

Obstructive Sleep Apnea Syndrome in Children Clinical Trial

— RCT ATE/ATT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676181
• Other study ID #: 2011/333-31/4
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: March 2017

Study information

• Verified date: March 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome in Children
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Procedure:
• Adenotonsillectomy
Total removal of tonsils and adenoid tissue with cold-steel
• Adenotonsillotomy
Partial removal of tonsils with coblation and total removal of adenoids with cold steel

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital, ORL dep	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Per- and postoperative bleeding	The two groups (ATT and ATE) will be compared concerning per- and postoperative bleeding.	One year
Other	changes in polysomnographic parameters other than AHI	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
Other	Differences in postoperative pain	The two groups will be compared with questionnaires and consumption of analgetics concerning the degree of postoperative pain.	One year
Other	Number of patients who need reoperations	The patient may need reoperations, either because of postoperative bleeding or because the tonsils have regrowth	One, three and ten years
Other	Abnormalities in DNA analysis of blood and tonsil tissue	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
Primary	Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)	AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.	One, three and ten years
Secondary	Changes in quality of life questionnaires (OSA18 and SDQ)	Parents answering to quality of life-questionnaire OSA18 and SDQ (Strengths and Difficulties Questionnaire) before and after surgical intervention	One, three and ten Years