Voice Rest and Injection Laryngoplasty

NCT05542550 | Unknown

• 1 other identifier: HSR220245
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the subjective, objective, and aerodynamic impact of voice rest following injection augmentation and compare the outcomes to patients with no post-procedure voice restrictions.

Conditions

Vocal Cord Paralysis

Outcome Measures

Primary Outcomes (1)

• Patient-perceived voice improvement

  Voice Handicap Index - 10. Scale range 0-40. Lower score designates lower voice impairment

  2 weeks

Secondary Outcomes (2)

• GRBAS- Grade, Roughness, Breathiness, Asthenia, Strain

  2 weeks

• Phonation threshold pressure

  2 weeks

Study Arms (2)

Voice Rest

ACTIVE COMPARATOR

48 hours of voice rest prescribed following injection

Behavioral: Voice Rest

No voice rest

EXPERIMENTAL

No voice rest required following injection

Behavioral: No Voice Rest

Interventions

Voice Rest BEHAVIORAL

Voice rest restricting patient phonation

Voice Rest

No Voice Rest BEHAVIORAL

No Voice rest

No voice rest

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years old
• Undergoing injection augmentation by Dr. McGarey, Dr. Torrecillas, or Dr. Daniero for the following conditions:
• Glottic insufficiency from atrophy, scar, or presbylarynx
• Unilateral or bilateral vocal fold immobility
• Unilateral or bilateral vocal fold hypomobility

You may not qualify if:

• Prior history of head and neck radiation.
• Active or recent (within 3 months) chemotherapy.
• Age \<18 years old
• Incarcerated individuals will be excluded due to inability to enroll in post-intervention clinic visit
• Presence of posterior glottic stenosis
• Presence of acute laryngeal injury
• Bedside inpatient injection augmentation
• Vocal fold Injection with steroids or cidofovir

Sponsors & Collaborators

• University of Virginia: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James J Daniero, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James J Daniero, MD

CONTACT

4349242040; jjd5h@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only patient is aware of treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized to one of two arms: no voice rest following injection and 48 hours voice rest following injection

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)