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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Vibeke Backer, Bispebjerg Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520624
First Posted: August 24, 2007
Last Update Posted: November 6, 2013
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.
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Vibeke Backer, Bispebjerg Hospital
  Purpose
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 Intervention
Exercise-induced Laryngomalacia Device: inspiratory muscle strength training Procedure: Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vibeke Backer, Bispebjerg Hospital:

Estimated Enrollment: 95
Arms Assigned Interventions
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

  Eligibility

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 Submitted: August 23, 2007
First Posted: August 24, 2007
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