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

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ClinicalTrials.gov Identifier: NCT00520624
Recruitment Status : Unknown
Verified November 2013 by Vibeke Backer, Bispebjerg Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 24, 2007
Last Update Posted : November 6, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Exercise-induced Laryngomalacia Device: inspiratory muscle strength training Procedure: Surgery

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520624


Contacts
Contact: Pernille Christensen +45 22 95 05 04 piller82@yahoo.com

Locations
Denmark
Bispebjerg Hospital, Lungemedicinsk Forskningsenhed Recruiting
Copenhagen, Denmark
Contact: Pernille Christensen    +45 22 95 05 04      
Sponsors and Collaborators
Bispebjerg Hospital
Rigshospitalet, Denmark
Investigators
Study Director: Vibeke Backer Bispebjerg Hospital
More Information

Responsible Party: Vibeke Backer, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00520624     History of Changes
Other Study ID Numbers: PC-EIL-07-ELITE
First Posted: August 24, 2007    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Keywords provided by Vibeke Backer, Bispebjerg Hospital:
EIL

Additional relevant MeSH terms:
Laryngomalacia
Cartilage Diseases
Musculoskeletal Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Connective Tissue Diseases