NCT02315911

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

4.2 years

First QC Date

December 8, 2014

Last Update Submit

April 4, 2019

Conditions

Sleep Apnea, ObstructiveOtorhinolaryngologic DiseasesPediatric Disorder

Keywords

TonsillectomyAdenoidectomyAdenoidpharyngoplastyOSA

Outcome Measures

Primary Outcomes (1)

  • obstructive apnea hypopnea index

    with full-night polysomnography

    6 months

Secondary Outcomes (6)

  • oxygen desaturation index

    6 months

  • postoperative pain

    6 months

  • per- and postoperative bleeding

    postoperatively, weeks

  • quality of life

    6 months

  • Innate lymphoid cells in tonsils

    6 months

  • +1 more secondary outcomes

Other Outcomes (2)

  • longterm results

    3 years

  • longterm results

    10 years

Study Arms (4)

expectancy for mild-moderate OSA

NO INTERVENTION

6 months expectancy

ATE for mild-moderate OSA

EXPERIMENTAL

adeno-tonsillectomy

Procedure: ATE

ATE for severe OSA

EXPERIMENTAL

adeno-tonsillectomy

Procedure: ATE

APP for severe OSA

EXPERIMENTAL

adeno-pharyngoplasty

Procedure: APP

Interventions

ATEPROCEDURE

surgical removal of adenoids and tonsils

Also known as: adeno-tonsillectomy
ATE for mild-moderate OSAATE for severe OSA
APPPROCEDURE

surgical removal of adenoids and tonsils and suturing of palatal pillars

Also known as: adeno-pharyngoplasty
APP for severe OSA

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • OAHI \>= 2
  • Tonsillary hypertrophy, Brodsky size 2-4
  • Adequate swedish knowledge

You may not qualify if:

  • Cardiovascular disorders
  • Pulmonary disorders
  • Neuromuscular disorders
  • Cranoifacial malformations
  • Genetic disorders
  • Earlier performed adenoid-tonsillary-surgery
  • Bleeding disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 40965870DERIVED

  • 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.

    PMID: 32463430DERIVED

  • 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.

    PMID: 29852045DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveOtorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Bo Tideholm

    ENT-clinic, Karolinska University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass professor

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 12, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

SE(1)