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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| expectancy for mild-moderate OSA | No Intervention | 6 months expectancy | |
| ATE for mild-moderate OSA | Experimental | adeno-tonsillectomy |
|
| ATE for severe OSA | Experimental | adeno-tonsillectomy |
|
| APP for severe OSA | Experimental | adeno-pharyngoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATE | Procedure | surgical removal of adenoids and tonsils |
|
| Measure | Description | Time Frame |
|---|---|---|
| obstructive apnea hypopnea index | with full-night polysomnography | 6 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| longterm results | with new polysomnography and questionnaires. Evaluate number of patients that are cured, AHI below 2. | 3 years |
| longterm results | with new polysomnography and questionnaires.Evaluate number of patients that are cured, AHI below 2. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Tideholm | ENT-clinic, Karolinska University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | 14186 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40965870 | Derived | Sjolander I, Fehrm J, Borgstrom A, Nerfeldt P, Friberg D. Adenotonsillectomy vs Watchful Waiting in Pediatric Mild to Moderate Obstructive Sleep Apnea: The KATE Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Nov 1;151(11):1038-1045. doi: 10.1001/jamaoto.2025.2831. | |
| 32463430 | Derived | Fehrm J, Nerfeldt P, Browaldh N, Friberg D. Effectiveness of Adenotonsillectomy vs Watchful Waiting in Young Children With Mild to Moderate Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2020 Jul 1;146(7):647-654. doi: 10.1001/jamaoto.2020.0869. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D010038 | Otorhinolaryngologic Diseases |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| APP | Procedure | surgical removal of adenoids and tonsils and suturing of palatal pillars |
|
|
| 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 |
| 10 years |
| 29852045 | Derived | Fehrm J, Nerfeldt P, Sundman J, Friberg D. Adenopharyngoplasty vs Adenotonsillectomy in Children With Severe Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):580-586. doi: 10.1001/jamaoto.2018.0487. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |