Otorhinolaryngologic Diseases, Pediatric Disorder, Sleep Apnea, Obstructive
Conditions
Keywords
Tonsillectomy, Adenoidectomy, Adenoidpharyngoplasty, OSA
Brief summary
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
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.
Interventions
PROCEDUREATE
surgical removal of adenoids and tonsils
PROCEDUREAPP
surgical removal of adenoids and tonsils and suturing of palatal pillars
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| obstructive apnea hypopnea index | 6 months | with full-night polysomnography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| oxygen desaturation index | 6 months | with full-night polysomnography |
| postoperative pain | 6 months | visuell analog scale, questionnaire diaries. Number of days until normal diet. |
| per- and postoperative bleeding | postoperatively, weeks | description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively |
| Innate lymphoid cells in tonsils | 6 months | To investigate the amount of Innate lymphoid cells in children with OSA |
| side-effects of surgery | 6 months | with a questionnaire evaluate if the child postoperatively will have speech-or swallowing difficulties. The parents will respond with a four-point Likert scale |
| quality of life | 6 months | Questionnaires validated, SDQ and OSA-18 |
Other
| Measure | Time frame | Description |
|---|---|---|
| longterm results | 3 years | with new polysomnography and questionnaires. Evaluate number of patients that are cured, AHI below 2. |
Countries
Sweden
Outcome results
None listed