Clinical trial NCT02315911: Randomized Control Trials of Surgery for Pediatric OSA
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Otorhinolaryngologic Diseases
Pediatric Disorder
Keywords: Tonsillectomy
Adenoidectomy
Adenoidpharyngoplasty
OSA
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 143
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: obstructive apnea hypopnea index
timeFrame: 6 months
Secondary outcomes:
measure: oxygen desaturation index
timeFrame: 6 months
measure: postoperative pain
timeFrame: 6 months
measure: per- and postoperative bleeding
timeFrame: postoperatively, weeks
measure: quality of life
timeFrame: 6 months
measure: Innate lymphoid cells in tonsils
timeFrame: 6 months
measure: side-effects of surgery
timeFrame: 6 months
Other outcomes:
measure: longterm results
timeFrame: 3 years
measure: longterm results
timeFrame: 10 years
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: ENT-clinic, Karolinska University Hospital
name: Bo Tideholm
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.