Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal InsufficiencyNCT06161064
Voice and Swallow Outcomes After Office-based Injection Laryngoplasty in Patients With Glottal Insufficiency
A study testing Hyaluronic acid in people with Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal Insufficiency, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal Insufficiency
- What is being tested?
- Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal Insufficiency
- Being tested
- Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
hyaluronic acid is temporary material using for augmentation of vocal folds in patients with glottal insufficiency
| Study group | Role | What they receive |
|---|---|---|
| office-based injection laryngoplasty | Other | office-based injection laryngoplasty by using hyaluronic acid Receives: Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1, 3 and 6 months
Secondary outcomes (1)
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
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Bakhiet Mahmoud, Sohag University
- Investigators
- ayaa bakhet, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161064
- Sponsor's protocol ID
- Sohagu
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: voice and swallow outcomes after office-based injection laryngoplasty in patients with glottal insufficiency
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice and Swallow Outcomes After Office-based Injection Laryngoplasty in Patients With Glottal Insufficiency
- ClinicalTrials.gov ID
- NCT06161064
- Acronym / sponsor ID
- Sohagu
- Conditions
- Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| office-based injection laryngoplasty | Other | Drug: Hyaluronic acidoffice-based injection laryngoplasty by using hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acidhyaluronic acid is temporary material using for augmentation of vocal folds in patients with glottal insufficiency | Drug | office-based injection laryngoplasty |
Primary outcome
voice evaluation using voice handicap index in patients with glottal insufficiency before and after injection laryngoplasty
Time frame: 1, 3 and 6 months
voice handicap index is a multiple questions about voice disorders patients answered before and after injection laryngoplasty
1 secondary outcome
voice evaluation using acoustics in patients with glottal insufficiency before and after injection laryngoplasty
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Yes. voice and swallow outcomes after office-based injection laryngoplasty in patients with glottal insufficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ayaa bakhet principal investigator
Sohag University
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid in people with Voice and Swallow Outcomes After Injection Laryngoplasty in Patients With Glottal Insufficiency, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ayaa bakhet, resident (01094555772, ayamasaod@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
voice evaluation using voice handicap index in patients with glottal insufficiency before and after injection laryngoplasty (time frame: 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.