Obstructive Sleep Apnea Syndrome in Children
Conditions
Keywords
Obstructive sleep apnea syndrome, Children, Polysomnography, Surgery, Coblation, Tonsils, Tonsillectomy
Brief 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.
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.
Interventions
PROCEDUREAdenotonsillectomy
Total removal of tonsils and adenoid tissue with cold-steel
PROCEDUREAdenotonsillotomy
Partial removal of tonsils with coblation and total removal of adenoids with cold steel
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in polysomnographic parameter AHI (Apnea Hypopnea Index) | One, three and ten years | AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in quality of life questionnaires (OSA18 and SDQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Differences in postoperative pain | One year | The two groups will be compared with questionnaires and consumption of analgetics concerning the degree of postoperative pain. |
| Per- and postoperative bleeding | One year | The two groups (ATT and ATE) will be compared concerning per- and postoperative bleeding. |
| Abnormalities in DNA analysis of blood and tonsil tissue | 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 |
| Number of patients who need reoperations | One, three and ten years | The patient may need reoperations, either because of postoperative bleeding or because the tonsils have regrowth |
| changes in polysomnographic parameters other than AHI | 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. |
Countries
Sweden
Outcome results
None listed