Combined speech pathology and amitriptyline treatment for vocal cord dysfunction.

Phase 3

Recruiting

• Conditions: Vocal Cord Dysfunction; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12619000158167
• Lead Sponsor: aTrobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-04
• Last Update Posted: 22 October 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Adults with vocal cord dysfunction diagnosed using laryngoscopy. Diagnosis defined as abnormal adduction of the vocal folds during inspiration or > 50% adduction during expiration.

Exclusion Criteria

previous speech pathology treatment for vocal cord dysfunction
contraindications for the use of amitriptyline including pregnancy and breast feeding
Lung pathology excluding asthma
progressive neurological condition
structural vocal fold pathology
inability to attend study visits

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vocal cord dysfunction symptoms as assessed by - Vocal Cord Dysfunction Questionnaire (VCDQ)[Baseline and post treatment - week 11]

Secondary Outcome Measures

Name	Time	Method
throat hypersensitivity symptoms including irritation, pain and obstruction as assessed by an overall composite score on the Laryngeal Hypersensitivity Questionnaire (LHQ)[baseline and post treatment - week 11];auditory - perceptual voice measure using the Consensus Auditory Perceptual Evaluation of Voice (CAPE-V)[baseline and post treatment - week 11];voice quality of life measure using the Voice Handicap Index (VHI)[baseline and post treatment - week 11];anxiety and depression measure using the Hospital Anxiety and Depression Scale (HADS)[baseline and post treatment - week 11]