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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06161064
Enrollment
10
Registered
2023-12-07
Start date
2023-12-31
Completion date
2024-12-31
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

DRUGHyaluronic acid

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
voice evaluation using voice handicap index in patients with glottal insufficiency before and after injection laryngoplasty1, 3 and 6 monthsvoice handicap index is a multiple questions about voice disorders patients answered before and after injection laryngoplasty

Secondary

MeasureTime frameDescription
voice evaluation using acoustics in patients with glottal insufficiency before and after injection laryngoplasty1, 3 and 6 monthsThe 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

Contacts

Primary Contactayaa bakhet, resident
ayamasaod@med.sohag.edu.eg01094555772

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026