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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 Bispebjerg Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Vibeke Backer, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00520624
First received: August 23, 2007
Last updated: November 5, 2013
Last verified: November 2013
  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:


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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520624

Locations
Denmark
Bispebjerg Hospital, Lungemedicinsk Forskningsenhed
Copenhagen, Denmark
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 
Study First Received: August 23, 2007
Last Updated: November 5, 2013
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 December 09, 2016