Randomized Control Trials of Surgery for Pediatric OSA

Study Overview
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Brief Summary
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Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA. Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE or APP. Pediatric age span of 2 until 4,9 years.

Detailed Description
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Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the family is asked to be in the study. If yes, the doctor take a sealed envelope and open it, either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether PSG shows b) severe OSA and the family accept participation the child is operated within a month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2) above 30. A sealed envelope is open in the operating room by the surgeon. The child is randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded for the family, who will not know which method the child has undergone. After 6 months all children will undergo follow-up with PSG and questionnaires. If the expectancy group will deteriorate during waiting time, or the child still has moderate to severe OSA, they will undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be evaluated with two PSG, 80 in each group.

Official Title
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Randomized Controlled Studies of Sugery for Pediatric OSA: Part 1 Expectancy Compared to Adeno-tonsillectomy for Mild-moderate OSA. Part 2 Adeno-tonsillectomy Compared to Adeno-pharyngoplasty for Severe OSA.

Conditions
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Sleep Apnea, Obstructive, Otorhinolaryngologic Diseases, Pediatric Disorder

Intervention / Treatment
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* Procedure: ATE
* Procedure: APP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OAHI >= 2 Tonsillary hypertrophy, Brodsky size 2-4 Adequate swedish knowledge Exclusion Criteria: Cardiovascular disorders Pulmonary disorders Neuromuscular disorders Cranoifacial malformations Genetic disorders Earlier performed adenoid-tonsillary-surgery Bleeding disorders

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: expectancy for mild-moderate OSA<br>6 months expectancy | |
| Experimental: ATE for mild-moderate OSA<br>adeno-tonsillectomy | Procedure: ATE<br>* surgical removal of adenoids and tonsils<br>* Other names: adeno-tonsillectomy;|
| Experimental: ATE for severe OSA<br>adeno-tonsillectomy | Procedure: ATE<br>* surgical removal of adenoids and tonsils<br>* Other names: adeno-tonsillectomy;|
| Experimental: APP for severe OSA<br>adeno-pharyngoplasty | Procedure: APP<br>* surgical removal of adenoids and tonsils and suturing of palatal pillars<br>* Other names: adeno-pharyngoplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obstructive apnea hypopnea index | with full-night polysomnography | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen desaturation index | with full-night polysomnography | 6 months | 
| postoperative pain | visuell analog scale, questionnaire diaries. Number of days until normal diet. | 6 months | 
| per- and postoperative bleeding | description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively | postoperatively, weeks | 
| quality of life | Questionnaires validated, SDQ and OSA-18 | 6 months | 
| Innate lymphoid cells in tonsils | To investigate the amount of Innate lymphoid cells in children with OSA | 6 months | 
| side-effects of surgery | with a questionnaire evaluate if the child postoperatively will have speech-or swallowing difficulties. The parents will respond with a four-point Likert scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, Adenoidectomy, Adenoidpharyngoplasty, OSA