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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00520624
Recruitment Status : Withdrawn (No patients willing to join)
First Posted : August 24, 2007
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Vibeke Backer, Bispebjerg Hospital

Tracking Information
First Submitted Date  ICMJE August 23, 2007
First Posted Date  ICMJE August 24, 2007
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Exercise-induced Laryngomalacia in Elite Athletes
Official Title  ICMJE Treatment of Exercise-induced Laryngo Obstruction in Elite Athletes
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Exercise-induced Laryngomalacia
Intervention  ICMJE
  • Device: inspiratory muscle strength training
  • Procedure: Surgery
Study Arms  ICMJE
  • Experimental: 1
    Treatment 1, for those with high degree of EIL
    Intervention: Device: inspiratory muscle strength training
  • Experimental: 2
    Treatment 2, for those with high degree of EIL
    Intervention: 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
    Intervention: Device: inspiratory muscle strength training
  • No Intervention: 5
    Control group of those with low degree of EIL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 26, 2021)		 0
Original Estimated Enrollment  ICMJE
 (submitted: August 23, 2007)		 95
Actual Study Completion Date  ICMJE January 2020
Actual Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00520624
Other Study ID Numbers  ICMJE PC-EIL-07-ELITE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vibeke Backer, Bispebjerg Hospital
Study Sponsor  ICMJE Bispebjerg Hospital
Collaborators  ICMJE Rigshospitalet, Denmark
Investigators  ICMJE
Study Director: Vibeke Backer Bispebjerg Hospital
PRS Account Bispebjerg Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP