NCT00520624

Brief Summary

Treatment of exercise-induced laryngomalacia (an obstruction of larynx during physical activity) in elite athletes using two different treatments. The study is randomized with control groups.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

August 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
5.4 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

7 years

First QC Date

August 23, 2007

Last Update Submit

January 26, 2021

Conditions

Exercise-induced Laryngomalacia

Keywords

EIL

Study Arms (5)

1

EXPERIMENTAL

Treatment 1, for those with high degree of EIL

Device: inspiratory muscle strength training

2

EXPERIMENTAL

Treatment 2, for those with high degree of EIL

Procedure: Surgery

3

NO INTERVENTION

Control group of those with high degree of EIL

4

EXPERIMENTAL

Treatment 1, for those with low degree of EIL

Device: inspiratory muscle strength training

5

NO INTERVENTION

Control group of those with low degree of EIL

Interventions

inspiratory muscle strength trainingDEVICE
14
SurgeryPROCEDURE
2

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Laryngoscopically verified EIL,
  • Elite athlete for a minimum of 1 year and continuing for a minimum 6 months after start of treatment

You may not qualify if:

  • Has to be able to run on treadmill

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Lungemedicinsk Forskningsenhed

Copenhagen, Denmark

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Vibeke Backer

    Bispebjerg Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 24, 2007

Study Start

January 1, 2013

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

DK(1)