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

NCT06161064 | Unknown

• 1 other identifier: Sohagu
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• voice evaluation using acoustics in patients with glottal insufficiency before and after injection laryngoplasty

  1, 3 and 6 months

Study Arms (1)

office-based injection laryngoplasty

OTHER

office-based injection laryngoplasty by using hyaluronic acid

Drug: Hyaluronic acid

Interventions

Hyaluronic acid DRUG

hyaluronic acid is temporary material using for augmentation of vocal folds in patients with glottal insufficiency

office-based injection laryngoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• ayaa bakhet

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ayaa bakhet, resident

CONTACT

01094555772; ayamasaod@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: sohag university

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 7, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: december,2024