PresbylarynxNCT03749863
Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
A study testing Serial PRP injections in people with Presbylarynx and Atrophy; Larynx, run by University of Southern California at 1 site in United States.
Trial summary
This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presbylarynx, Atrophy; Larynx, Dysphonia
- What is being tested?
- Serial PRP injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 30 Sep 2022
- 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
- Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
- Patients with a pre-injection VHI-10 score of ≥ 10
- Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
- Ability to give informed consent
Who cannot join
- Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
- Current smoker
- Underlying coagulopathy, thrombocytopenia, or platelet dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Safety and Efficacy of Serial Platelet-Rich Plasma Injections for Treatment of Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency
Read the detailed description
Vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging Americans, up to 35% of those 65 or older. Currently used treatment methods include voice therapy, injections of inert fillers, and laryngeal framework surgery. These modalities are imperfect with voice therapy requiring considerable time commitment, filler injections generally temporary in benefit, and surgery with increased risks. The investigators intend to conduct a single-arm study to assess the safety and efficacy of autologous platelet-rich plasma (PRP) injection for vocal fold atrophy, sulcus vocalis and scar. PRP is a substance purified from the patient's own blood that consists of platelets, growth factors, and other regenerative molecules that have been shown to promote rejuvenation in a variety of tissue types. Patients with vocal fold atrophy, sulcus vocalis, and scar identified in the USC Voice Center will be offered participation in a study to receive serial PRP injections in one vocal fold. Outcome measures evaluated pre- and post-injection and over follow-up visits will include various patient reported quality of life indices, objective clinical assessments of voice, and laryngeal videostroboscopy examinations. The investigators hypothesize that serial PRP injections will significantly improve vocal fold mucosal volume, morphology, and dysphonia in these patients with no adverse side effects.
- Conditions
- Presbylarynx, Atrophy; Larynx, Dysphonia, Vocal Cord Atrophy, Presbylarynges, Vocal Fold Scar
- Being tested
- Serial PRP injections
- Keywords
- presbyphonia, presbylarynx, vocal fold atrophy, dysphonia, platelet rich plasma, PRP, vocal fold scar
- Medical subject headings
- Atrophy, Laryngeal Diseases, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial PRP injectionsProcedure or surgery
Autologous platelet-rich plasma will be injected into the vocal fold mucosa in a serial fashion, once per month for a total of 4 injections.
| Study group | Role | What they receive |
|---|---|---|
| Serial PRP injections | Experimental | This arm will receive experimental intervention of serial monthly platelet-rich plasma (PRP) injections to a unilateral vocal fold mucosa for a total of 4 injections. Receives: Procedure: Serial PRP injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale
Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening
Measured: 4 months
Secondary outcomes (3)
Voice-Related Quality of Life as assessed by Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI)
VHI-10 is a patient questionnaire with 10 statements rated from 0 to 4 with overall scale 0-40; VFI is a patient questionnaire with 19 statements rated from 0-4 with overall scale 0-76.
Measured: 4 months
Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument
Blinded evaluations of audio voice recordings will be performed by laryngologists and speech-language pathologists using the CAPE-V, which grades overall severity, roughness, breathiness, strain, pitch, and loudness from 0-100.
Measured: 4 months
Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form
Blinded assessments of recorded laryngeal videostroboscopy exams will be performed by laryngologists and speech-language pathologists using a modified version of the VALI, which is a graphical rating form to grade various components seen on stroboscopy.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start18 Feb 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PresbylarynxStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Model description
- Serial monthly vocal fold injections with PRP for total of 4 injections.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Johns, University of Southern California
- Investigators
- Michael Johns, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749863
- Sponsor's protocol ID
- APP-18-05224
- Status last verified
- May 2022
- First submitted
- 29 Sep 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradley JP, Hapner E, Johns MM 3rd. What is the optimal treatment for presbyphonia? Laryngoscope. 2014 Nov;124(11):2439-40. doi: 10.1002/lary.24642. Epub 2014 Aug 5. No abstract available.
PubMed 25132245Crawley BK, Dehom S, Thiel C, Yang J, Cragoe A, Mousselli I, Krishna P, Murry T. Assessment of Clinical and Social Characteristics That Distinguish Presbylaryngis From Pathologic Presbyphonia in Elderly Individuals. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):566-571. doi: 10.1001/jamaoto.2018.0409.
PubMed 29799925Cobden SB, Ozturk K, Duman S, Esen H, Aktan TM, Avunduk MC, Elsurer C. Treatment of Acute Vocal Fold Injury With Platelet-Rich Plasma. J Voice. 2016 Nov;30(6):731-735. doi: 10.1016/j.jvoice.2015.07.012. Epub 2015 Aug 17.
PubMed 26292799Woo SH, Jeong HS, Kim JP, Koh EH, Lee SU, Jin SM, Kim DH, Sohn JH, Lee SH. Favorable vocal fold wound healing induced by platelet-rich plasma injection. Clin Exp Otorhinolaryngol. 2014 Mar;7(1):47-52. doi: 10.3342/ceo.2014.7.1.47. Epub 2014 Feb 5.
PubMed 24587881Ozgursoy SK, Tunckasik F, Tunckasik ME, Akincioglu E, Dogan H, Beriat GK. Histopathologic Evaluation of Hyaluronic Acid and Plasma-Rich Platelet Injection into Rabbit Vocal Cords: An Experimental Study. Turk Arch Otorhinolaryngol. 2018 Mar;56(1):30-35. doi: 10.5152/tao.2018.2942. Epub 2018 Mar 1.
PubMed 29988271
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Serial Platelet-Rich Plasma Injections for Treatment of Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
- ClinicalTrials.gov ID
- NCT03749863
- Acronym / sponsor ID
- APP-18-05224
- Conditions
- Presbylarynx, Atrophy; Larynx, Dysphonia, Vocal Cord Atrophy, Presbylarynges, Vocal Fold Scar
- Keywords
- presbyphonia, presbylarynx, vocal fold atrophy, dysphonia, platelet rich plasma, PRP, vocal fold scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 Nov 2018 (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.
This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency
Detailed description
Vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging Americans, up to 35% of those 65 or older. Currently used treatment methods include voice therapy, injections of inert fillers, and laryngeal framework surgery. These modalities are imperfect with voice therapy requiring considerable time commitment, filler injections generally temporary in benefit, and surgery with increased risks. The investigators intend to conduct a single-arm study to assess the safety and efficacy of autologous platelet-rich plasma (PRP) injection for vocal fold atrophy, sulcus vocalis and scar. PRP is a substance purified from the patient's own blood that consists of platelets, growth factors, and other regenerative molecules that have been shown to promote rejuvenation in a variety of tissue types. Patients with vocal fold atrophy, sulcus vocalis, and scar identified in the USC Voice Center will be offered participation in a study to receive serial PRP injections in one vocal fold. Outcome measures evaluated pre- and post-injection and over follow-up visits will include various patient reported quality of life indices, objective clinical assessments of voice, and laryngeal videostroboscopy examinations. The investigators hypothesize that serial PRP injections will significantly improve vocal fold mucosal volume, morphology, and dysphonia in these patients with no adverse side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Serial monthly vocal fold injections with PRP for total of 4 injections.
| Arm | Type | Receives |
|---|---|---|
| Serial PRP injections | Experimental | Procedure: Serial PRP injectionsThis arm will receive experimental intervention of serial monthly platelet-rich plasma (PRP) injections to a unilateral vocal fold mucosa for a total of 4 injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
- Patients with a pre-injection VHI-10 score of ≥ 10
- Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
- Ability to give informed consent
Key exclusion criteria (3 listed)
- Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
- Current smoker
- Underlying coagulopathy, thrombocytopenia, or platelet dysfunction
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 |
|---|---|---|
| Serial PRP injectionsAutologous platelet-rich plasma will be injected into the vocal fold mucosa in a serial fashion, once per month for a total of 4 injections. | Procedure or surgery | Serial PRP injections |
Primary outcome
Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale
Time frame: 4 months
Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening
3 secondary outcomes
Voice-Related Quality of Life as assessed by Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI)
Time frame: 4 months
Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument
Time frame: 4 months
Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 25132245Bradley JP, Hapner E, Johns MM 3rd. What is the optimal treatment for presbyphonia? Laryngoscope. 2014 Nov;124(11):2439-40. doi: 10.1002/lary.24642. Epub 2014 Aug 5. No abstract available.
- Background: PubMed 29799925Crawley BK, Dehom S, Thiel C, Yang J, Cragoe A, Mousselli I, Krishna P, Murry T. Assessment of Clinical and Social Characteristics That Distinguish Presbylaryngis From Pathologic Presbyphonia in Elderly Individuals. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):566-571. doi: 10.1001/jamaoto.2018.0409.
- Background: PubMed 26292799Cobden SB, Ozturk K, Duman S, Esen H, Aktan TM, Avunduk MC, Elsurer C. Treatment of Acute Vocal Fold Injury With Platelet-Rich Plasma. J Voice. 2016 Nov;30(6):731-735. doi: 10.1016/j.jvoice.2015.07.012. Epub 2015 Aug 17.
- Background: PubMed 24587881Woo SH, Jeong HS, Kim JP, Koh EH, Lee SU, Jin SM, Kim DH, Sohn JH, Lee SH. Favorable vocal fold wound healing induced by platelet-rich plasma injection. Clin Exp Otorhinolaryngol. 2014 Mar;7(1):47-52. doi: 10.3342/ceo.2014.7.1.47. Epub 2014 Feb 5.
- Background: PubMed 29988271Ozgursoy SK, Tunckasik F, Tunckasik ME, Akincioglu E, Dogan H, Beriat GK. Histopathologic Evaluation of Hyaluronic Acid and Plasma-Rich Platelet Injection into Rabbit Vocal Cords: An Experimental Study. Turk Arch Otorhinolaryngol. 2018 Mar;56(1):30-35. doi: 10.5152/tao.2018.2942. Epub 2018 Mar 1.
- Individual participant dataSharing planned: No
Related trials for Presbylarynx
Active, not recruiting
Improving Voice Production for Adults With Age-related Dysphonia
Presbylarynx, Age-Related Dysphonia
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.
Michael Johns, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial PRP injections in people with Presbylarynx and Atrophy; Larynx, run by University of Southern California at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749863, which also lists 5 linked publications.
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 10 May 2023.