Randomized Control Trials of Surgery for Pediatric OSA

Not Applicable

Completed

• Conditions: Pediatric Disorder; Sleep Apnea, Obstructive; Otorhinolaryngologic Diseases
• Interventions: Procedure: ATE; Procedure: APP

• Registration Number: NCT02315911
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-08
• Study First Submitted QC: 2014-12-11
• Study First Posted: 2014-12-12
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ATE for mild-moderate OSA	ATE	adeno-tonsillectomy
ATE for severe OSA	ATE	adeno-tonsillectomy
APP for severe OSA	APP	adeno-pharyngoplasty

Primary Outcome Measures

Name	Time	Method
obstructive apnea hypopnea index	6 months	with full-night polysomnography

Secondary Outcome Measures

Name	Time	Method
per- and postoperative bleeding	postoperatively, weeks	description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively
quality of life	6 months	Questionnaires validated, SDQ and OSA-18
oxygen desaturation index	6 months	with full-night polysomnography
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
postoperative pain	6 months	visuell analog scale, questionnaire diaries. Number of days until normal diet.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden