Trial record 9 of 21 for:    Open Studies | "Cartilage Diseases"

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

This study is not yet open for participant recruitment.
Verified November 2013 by Bispebjerg Hospital
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
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

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 April 17, 2014