Treatment of Exercise-induced Laryngomalacia in Elite Athletes

NCT ID: NCT00520624

Last Updated: 2021-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Exercise-induced Laryngomalacia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Treatment 1, for those with high degree of EIL

Group Type EXPERIMENTAL

inspiratory muscle strength training

Intervention Type DEVICE

2

Treatment 2, for those with high degree of EIL

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

3

Control group of those with high degree of EIL

Group Type NO_INTERVENTION

No interventions assigned to this group

4

Treatment 1, for those with low degree of EIL

Group Type EXPERIMENTAL

inspiratory muscle strength training

Intervention Type DEVICE

5

Control group of those with low degree of EIL

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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inspiratory muscle strength training

Intervention Type DEVICE

Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vibeke Backer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vibeke Backer

Role: STUDY_DIRECTOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital, Lungemedicinsk Forskningsenhed

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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PC-EIL-07-ELITE

Identifier Type: -

Identifier Source: org_study_id

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