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Randomized Control Trials of Surgery for Pediatric OSA

Primary Purpose

Sleep Apnea, Obstructive, Otorhinolaryngologic Diseases, Pediatric Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ATE
APP
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Tonsillectomy, Adenoidectomy, Adenoidpharyngoplasty, OSA

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

expectancy for mild-moderate OSA

ATE for mild-moderate OSA

ATE for severe OSA

APP for severe OSA

Arm Description

6 months expectancy

adeno-tonsillectomy

adeno-tonsillectomy

adeno-pharyngoplasty

Outcomes

Primary Outcome Measures

obstructive apnea hypopnea index
with full-night polysomnography

Secondary Outcome Measures

oxygen desaturation index
with full-night polysomnography
postoperative pain
visuell analog scale, questionnaire diaries. Number of days until normal diet.
per- and postoperative bleeding
description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively
quality of life
Questionnaires validated, SDQ and OSA-18
Innate lymphoid cells in tonsils
To investigate the amount of Innate lymphoid cells in children with OSA
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

Full Information

First Posted
December 8, 2014
Last Updated
April 4, 2019
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02315911
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Otorhinolaryngologic Diseases, Pediatric Disorder
Keywords
Tonsillectomy, Adenoidectomy, Adenoidpharyngoplasty, OSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
expectancy for mild-moderate OSA
Arm Type
No Intervention
Arm Description
6 months expectancy
Arm Title
ATE for mild-moderate OSA
Arm Type
Experimental
Arm Description
adeno-tonsillectomy
Arm Title
ATE for severe OSA
Arm Type
Experimental
Arm Description
adeno-tonsillectomy
Arm Title
APP for severe OSA
Arm Type
Experimental
Arm Description
adeno-pharyngoplasty
Intervention Type
Procedure
Intervention Name(s)
ATE
Other Intervention Name(s)
adeno-tonsillectomy
Intervention Description
surgical removal of adenoids and tonsils
Intervention Type
Procedure
Intervention Name(s)
APP
Other Intervention Name(s)
adeno-pharyngoplasty
Intervention Description
surgical removal of adenoids and tonsils and suturing of palatal pillars
Primary Outcome Measure Information:
Title
obstructive apnea hypopnea index
Description
with full-night polysomnography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
oxygen desaturation index
Description
with full-night polysomnography
Time Frame
6 months
Title
postoperative pain
Description
visuell analog scale, questionnaire diaries. Number of days until normal diet.
Time Frame
6 months
Title
per- and postoperative bleeding
Description
description of bleeding amount per and postoperatively, number of patients needed to reoperate because of bleeding postoperatively
Time Frame
postoperatively, weeks
Title
quality of life
Description
Questionnaires validated, SDQ and OSA-18
Time Frame
6 months
Title
Innate lymphoid cells in tonsils
Description
To investigate the amount of Innate lymphoid cells in children with OSA
Time Frame
6 months
Title
side-effects of surgery
Description
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
6 months
Other Pre-specified Outcome Measures:
Title
longterm results
Description
with new polysomnography and questionnaires. Evaluate number of patients that are cured, AHI below 2.
Time Frame
3 years
Title
longterm results
Description
with new polysomnography and questionnaires.Evaluate number of patients that are cured, AHI below 2.
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Tideholm
Organizational Affiliation
ENT-clinic, Karolinska University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32463430
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. Erratum In: JAMA Otolaryngol Head Neck Surg. 2020 Dec 1;146(12):1181.
Results Reference
derived
PubMed Identifier
29852045
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.
Results Reference
derived

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Randomized Control Trials of Surgery for Pediatric OSA

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