Back to resultsTreatment of Exercise-induced Laryngomalacia in Elite Athletes (EIL)
Primary Purpose
Exercise-induced Laryngomalacia
Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
inspiratory muscle strength training
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Exercise-induced Laryngomalacia focused on measuring EIL
Eligibility Criteria
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
Sites / Locations
- Bispebjerg Hospital, Lungemedicinsk Forskningsenhed
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
No Intervention
Experimental
No Intervention
Arm Label
1
2
3
4
5
Arm Description
Treatment 1, for those with high degree of EIL
Treatment 2, for those with high degree of EIL
Control group of those with high degree of EIL
Treatment 1, for those with low degree of EIL
Control group of those with low degree of EIL
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00520624
First Posted
August 23, 2007
Last Updated
January 26, 2021
Sponsor
Bispebjerg Hospital
Collaborators
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00520624
Brief Title
Treatment of Exercise-induced Laryngomalacia in Elite Athletes
Acronym
EIL
Official Title
Treatment of Exercise-induced Laryngo Obstruction in Elite Athletes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No patients willing to join
Study Start Date
January 2013 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Rigshospitalet, Denmark
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Laryngomalacia
Keywords
EIL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment 1, for those with high degree of EIL
Arm Title
2
Arm Type
Experimental
Arm Description
Treatment 2, for those with high degree of EIL
Arm Title
3
Arm Type
No Intervention
Arm Description
Control group of those with high degree of EIL
Arm Title
4
Arm Type
Experimental
Arm Description
Treatment 1, for those with low degree of EIL
Arm Title
5
Arm Type
No Intervention
Arm Description
Control group of those with low degree of EIL
Intervention Type
Device
Intervention Name(s)
inspiratory muscle strength training
Intervention Type
Procedure
Intervention Name(s)
Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke Backer
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital, Lungemedicinsk Forskningsenhed
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment of Exercise-induced Laryngomalacia in Elite Athletes
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