NCT01676181

Brief Summary

Non-inferiority hypothesis; adenotonsillotomy is equally good as adenotonsillectomy in treating obstructive sleep apnea syndrome (OSAS) in children after one, three and ten years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

5.3 years

First QC Date

August 21, 2012

Last Update Submit

March 9, 2023

Conditions

Obstructive Sleep Apnea Syndrome in Children

Keywords

Obstructive sleep apnea syndromeChildrenPolysomnographySurgeryCoblationTonsilsTonsillectomy

Outcome Measures

Primary Outcomes (1)

  • Changes in polysomnographic parameter AHI (Apnea Hypopnea Index)

    AHI; the number of apneas and hypopneas per sleep hour, is measured through polysomnography before and after surgery.

    One, three and ten years

Secondary Outcomes (1)

  • Changes in quality of life questionnaires (OSA18 and SDQ)

    One, three and ten Years

Other Outcomes (5)

  • Per- and postoperative bleeding

    One year

  • changes in polysomnographic parameters other than AHI

    one, three and ten years

  • Differences in postoperative pain

    One year

  • +2 more other outcomes

Study Arms (2)

Adenotonsillectomy

ACTIVE COMPARATOR

Total removal of tonsils and adenoids with cold steel

Procedure: Adenotonsillectomy

Adenotonsillotomy

ACTIVE COMPARATOR

Partial removal of tonsils with coblation and total removal of adenoids with cold steel

Procedure: Adenotonsillotomy

Interventions

AdenotonsillectomyPROCEDURE

Total removal of tonsils and adenoid tissue with cold-steel

Adenotonsillectomy
AdenotonsillotomyPROCEDURE

Partial removal of tonsils with coblation and total removal of adenoids with cold steel

Adenotonsillotomy

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2-6 years
  • Clinical symptoms of OSAS (apneas, snoring, disturbed sleep)
  • Tonsil size 3-4 with the Brodsky scale (obstructing at least 50% of the oro-pharyngeal space)
  • Apnea-Hypopnea Index (AHI) 5-30 (moderate- severe OSA)

You may not qualify if:

  • Clinical signs of craniofacial anomalies or neuromuscular disorders
  • Obesity
  • Earlier having had surgery of tonsils or adenoid
  • Bleeding disorder
  • Cardiopulmonary disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, ORL dep

Stockholm, 141 86, Sweden

Location

Related Publications (2)

  • Blackshaw H, Springford LR, Zhang LY, Wang B, Venekamp RP, Schilder AG. Tonsillectomy versus tonsillotomy for obstructive sleep-disordered breathing in children. Cochrane Database Syst Rev. 2020 Apr 29;4(4):CD011365. doi: 10.1002/14651858.CD011365.pub2.

    PMID: 32347984DERIVED

  • Borgstrom A, Nerfeldt P, Friberg D. Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3231-3238. doi: 10.1007/s00405-019-05571-w. Epub 2019 Aug 3.

    PMID: 31377901DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Danielle Friberg, MD, PhD

    Karolinska University Hospital, ORL dep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, senior surgeon

Study Record Dates

First Submitted

August 21, 2012

First Posted

August 30, 2012

Study Start

November 1, 2011

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

SE(1)