Voice and Swallow Outcomes After Office-based Injection Laryngoplasty in Patients With Glottal Insufficiency

The purpose of this study is to evaluate voice quality and swallow outcomes of office-based injection laryngoplasty using hyaluronic acid in patients with Glottal insufficiency and assess all cases after 1, 3 and 6 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal Insufficiency
• Intervention / Treatment: Drug: Hyaluronic acid

Detailed Description

Glottic insufficiency (incompetence) is characterized by incomplete closure of the vocal folds when phonating, which causes inappropriate leakage of air through the glottis on attempting to phonate and there is an increased risk of aspiration. A wide range of laryngeal symptoms including dysphonia with or without dysphagia may result .There are varieties of causes of glottic insufficiency (GI); among the most common causes of symptomatic GI are vocal fold paralysis (complete immobility of the vocal fold), vocal fold paresis (weakness or partial immobility of the vocal fold) and presbylaryngis. Other causes of GI are sulcus vocalis, scarring or deformation of the vocal folds .Therefore, different therapy options were proposed for patients with GI based on the size of the glottic gap. Voice therapy is most suitable for patients with minimal glottic gap, regardless the reason.Injection augmentation is reserved for those with small or medium-sized glottic gap .Office-based vocal fold injection was used worldwide in early & late Cases of GI. Office-based vocal fold injection in acute cases such as iatrogenic injury of recurrent laryngeal nerve during surgery has many advantages, these include immediate symptomatic relief, the ability to titrate degree of medialization for optimized outcomes, and monitoring of the airway.Moreover, injection in early cases prevent compensatory mechanisms as ventricular hypertrophy. Recent studies suggest that injection laryngoplasty in early cases reduce the need for permanent laryngeal framework surgery.The ideal material to be used for injection should be biocompatible and inert to decrease the risk of local tissue reaction or fibrosis. Also, the material should be easy to use and have a low cost. Furthermore, it should be durable and resistant to resorption or migration, while it maintains the normal viscoelasticity of the vocal cord after injection.

So, there are 2 types of injection materials: temporary &permanent materials. Long-lasting injection materials(permanent) include autologous fat,calcium hydroxylapatite(CaHA) and taflon. Temporary injection materials include bovine gelatin, collagen-based products, carboxymethylcellulose and hyaluronic acid gel (HA). HA is among the most commonly used substances for injection laryngoplasty.

Actually, office-based vocal fold injection has different techniques such as percutaneous (trans-cricothyroid membrane, trans-thyroid cartilage, and trans-thyrohyoid membrane), per-oral, and trans-nasal endoscopic approaches. Typically, the three approaches are performed with a flexible laryngoscope in place, visualizing the larynx for visualization and to monitor injection effects.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ayaa bakhet, resident; Phone Number: 01094555772; Email: ayamasaod@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. The complaint of all patients is dysphonia with or without aspiration
2. Patients with small or large glottic gap
3. Patients at least 1-2 months after the onset of GI

Exclusion Criteria:

Patients who are 1- >18 years old 2-Irritable 3-Exaggerated gag reflexes 4-Cardiac problems 5-Active laryngeal carcinoma 6-Patients on chemo or radiotherapy

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: office-based injection laryngoplasty; office-based injection laryngoplasty by using hyaluronic acid	Drug: Hyaluronic acid; hyaluronic acid is temporary material using for augmentation of vocal folds in patients with glottal insufficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
voice evaluation using voice handicap index in patients with glottal insufficiency before and after injection laryngoplasty	voice handicap index is a multiple questions about voice disorders patients answered before and after injection laryngoplasty	1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
voice evaluation using acoustics in patients with glottal insufficiency before and after injection laryngoplasty	The vocal samples are obtained from the participants by holding a Microphone 10 cm in front of their mouth and producing sustained phonation. Each participant is asked to sustain the vowels /a/ /i/ /u/ followed by connected speech (counting from 1-5) using habitual and constant vocal pitch, loudness, and quality for at least 5 seconds with elimination of the irregularities in the beginning and end of utterance. The room for sampling is situated away from noise. Acoustic parameters as: Fundamental frequency, Jitter, Shimmer and noise to harmonic ratio	1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: ayaa bakhet, Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: Sohagu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: voice and swallow outcomes after office-based injection laryngoplasty in patients with glottal insufficiency
• IPD Sharing Time Frame: december,2024
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No