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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Bispebjerg Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00520624
First received: August 23, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00520624     History of Changes
Other Study ID Numbers: PC-EIL-07-ELITE
Study First Received: August 23, 2007
Last Updated: August 23, 2007
Health Authority: Denmark: Datatilsynet (Ministry of justice)

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013