Karolinska University Hospital
Stockholm, 14186, Sweden
NCT Number: NCT02315911
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.
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Notify Me2 year–5 year
All sexes
Interventional
Not applicable
Stockholm, 14186, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
surgical removal of adenoids and tonsils
Other names: adeno-tonsillectomy
surgical removal of adenoids and tonsils and suturing of palatal pillars
Other names: adeno-pharyngoplasty
Time frame: 6 months
with full-night polysomnography
Time frame: 6 months
with full-night polysomnography
Time frame: 6 months
visuell analog scale, questionnaire diaries. Number of days until normal diet.
Time frame: postoperatively, weeks
description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively
Time frame: 6 months
Questionnaires validated, SDQ and OSA-18
Time frame: 6 months
To investigate the amount of Innate lymphoid cells in children with OSA
Time frame: 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
Time frame: 3 years
with new polysomnography and questionnaires. Evaluate number of patients that are cured, AHI below 2.
Time frame: 10 years
with new polysomnography and questionnaires.Evaluate number of patients that are cured, AHI below 2.
Karolinska University Hospital
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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