Treatment of Exercise-induced Laryngomalacia in Elite Athletes (EIL)

January 26, 2021 updated by: Vibeke Backer, Bispebjerg Hospital

Treatment of Exercise-induced Laryngo Obstruction in Elite Athletes

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Bispebjerg Hospital, Lungemedicinsk Forskningsenhed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Has to be able to run on treadmill

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Treatment 1, for those with high degree of EIL
Device: inspiratory muscle strength training
EXPERIMENTAL: 2
Treatment 2, for those with high degree of EIL
Procedure: Surgery
NO_INTERVENTION: 3
Control group of those with high degree of EIL
EXPERIMENTAL: 4
Treatment 1, for those with low degree of EIL
Device: inspiratory muscle strength training
NO_INTERVENTION: 5
Control group of those with low degree of EIL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Rigshospitalet, Denmark

Investigators

  • Study Director: Vibeke Backer, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

August 23, 2007

First Submitted That Met QC Criteria

August 23, 2007

First Posted (ESTIMATE)

August 24, 2007

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-EIL-07-ELITE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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