Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064571
Status:
TERMINATED
Last Update Posted:
2006-04-24
First Post:
2003-07-09
Brief Title:
Surgery for Vocal Cord Paralysis
Sponsor:
National Institute on Deafness and Other Communication Disorders NIDCD
Organization:
National Institute on Deafness and Other Communication Disorders NIDCD
Study Overview
Official Title:
Medialization Vs Reinnervation for Vocal Cord Paralysis
Status:
TERMINATED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Unilateral vocal fold paralysis UVFP is caused by injury to the nerve to the affected vocal fold The injury to the vocal fold makes the affected persons voice sound breathy Voice therapy is usually tried first and if unsuccessful surgical treatment is considered The standard surgical treatment is called vocal fold medialization and aims to bring the injured cord to the midline An alternative surgical treatment vocal fold reinnervation aims to bring a new nerve supply to the injured vocal fold The reinnervation operation which has some potential advantages over the medialization operation also requires several months for final results to be gained The goal of this multicenter randomized clinical trial is to see which of the two surgical treatments produces a better outcome
In order to participate in this study patients with UVFP must meet all entry criteria and must be released from voice therapy by a speech-language pathologist Information collected for the study pre-surgery and at 6 and 12 months after surgery includes voice recordings movies made of vocal fold function airflow and pressure measurements of the voicebox and an outcomes questionnaire
In order to participate in this study patients with UVFP must meet all entry criteria and must be released from voice therapy by a speech-language pathologist Information collected for the study pre-surgery and at 6 and 12 months after surgery includes voice recordings movies made of vocal fold function airflow and pressure measurements of the voicebox and an outcomes questionnaire
Detailed Description:
Unilateral vocal fold paralysis UVFP is caused by injury to the recurrent laryngeal nerve Patients with UVFP may have significant impairment of vocal fold function including a breathy paralytic dysphonia There are several available approaches for the treatment of this condition Vocal fold medialization is currently used by most otolaryngologists and is probably the standard of care for treating UVFP An alternative approach is laryngeal reinnervation which has a number of potential advantages over medialization but which requires several months before a final result is achieved The primary goal of this multicenter randomized clinical trial is to determine which approach produces a better outcome
Patients with UVFP meeting all inclusion criteria and released from therapy by a speech-language pathologist will be randomized into either the medialization arm or the reinnervation arm The data collection protocol consists of voice recordings aerodynamic measurements electroglottography videostroboscopy and a clinical outcomes questionnaire collected pre-treatment and at 6 and 12 months post-treatment
Patients with UVFP meeting all inclusion criteria and released from therapy by a speech-language pathologist will be randomized into either the medialization arm or the reinnervation arm The data collection protocol consists of voice recordings aerodynamic measurements electroglottography videostroboscopy and a clinical outcomes questionnaire collected pre-treatment and at 6 and 12 months post-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None