Benign Neoplasm of True Vocal CordsNCT02634957
Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery
A study testing absolute voice rest in people with Benign Neoplasm of True Vocal Cords, run by University of Pittsburgh at 1 site in United States.
Trial summary
Absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Neoplasm of True Vocal Cords
- What is being tested?
- absolute voice rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 31 Jan 2020
- 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
- Patients with benign mid membranous vocal fold lesions such as the following:
- Polyps
- Cysts
- Sub-epithelial fibrous mass
- Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.
- Age 18 and older
Who cannot join
- Patients with any of the following will be excluded from the study:
- Reinke's edema
- Active smokers
- Ligamentous mid membranous vocal fold lesions
- RRP (Recurrent Respiratory Papillomatosis)
- Dysplasia
Show all 12Show fewer
- CIS (Carcinoma-in-situ)
- SCC (squamous cell carcinoma)
- Extent of surgery exceeds what is mentioned in the inclusion criteria (e.g., CO2 laser, balloon dilatation, vocal fold augmentation in addition to phonomicrosurgery)
- Previous vocal fold surgery
- Systemic steroids
- History of systemic illness that could affect wound healing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. Unfortunately there is no standardized protocol as to how long patients should rest their voice after phonomicrosurgery. To date, there are no studies in the literature directly comparing the impact of short-term and long-term voice rest on vocal fold healing and voice outcome after phonomicrosurgery.
Read the detailed description
The purpose of this study is to determine whether 3 days versus 7 days of absolute voice rest will result in different voice outcomes in patients who have undergone phonomicrosurgery for benign vocal fold lesions.
- Conditions
- Benign Neoplasm of True Vocal Cords
- Being tested
- absolute voice rest
- Keywords
- phonomicrosurgery, benign vocal fold lesions, voice rest, vhi-10, CPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
absolute voice restBehavioural
absolute voice rest is the complete elimination of any vocalization (no sounds, speaking or whispering)
| Study group | Role | What they receive |
|---|---|---|
| 3 day absolute voice rest | Experimental | participants would begin initiation of voice/speaking 3 days post phonomicrosurgery for benign vocal fold lesions Receives: Behavioral: absolute voice rest |
| 7 day absolute voice rest | Experimental | participants would begin initiation of voice/speaking 7 days post phonomicrosurgery for benign vocal fold lesions Receives: Behavioral: absolute voice rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Handicap Index - 10
Measured: 3 months post op
Voice Handicap Index - 10
Measured: 1 month post op
Secondary outcomes (3)
Cepstral Peak Prominence (CPP)
Measured: 1 month and 3 months post op
Average phonatory airflow in all voiced sentence
Measured: 1 month and 3 months post op
video stroboscopy findings
Measured: 1 month and 3 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Why it stopped: Due to change in available resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Neoplasm of True Vocal CordsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Libby Smith DO, University of Pittsburgh
- Investigators
- Libby Smith, DO, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634957
- Sponsor's protocol ID
- PRO15120009
- Status last verified
- Apr 2020
- First submitted
- 11 Dec 2015
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: de-identified information with outside collaborators
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Duration Of Absolute Voice Rest on Voice Outcome After Phonomicrosurgery
- ClinicalTrials.gov ID
- NCT02634957
- Acronym / sponsor ID
- PRO15120009
- Conditions
- Benign Neoplasm of True Vocal Cords
- Keywords
- phonomicrosurgery, benign vocal fold lesions, voice rest, vhi-10, CPP
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to change in available resources
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 18 Dec 2015 (estimated)
- 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.
Absolute voice rest is commonly prescribed after vocal fold surgery, also known as phonomicrosurgery, for benign vocal fold lesions. This is thought to decrease scarring of vocal folds, which could result in increasing tissue stiffness and limitations in optimal vocal outcome. Unfortunately there is no standardized protocol as to how long patients should rest their voice after phonomicrosurgery. To date, there are no studies in the literature directly comparing the impact of short-term and long-term voice rest on vocal fold healing and voice outcome after phonomicrosurgery.
Detailed description
The purpose of this study is to determine whether 3 days versus 7 days of absolute voice rest will result in different voice outcomes in patients who have undergone phonomicrosurgery for benign vocal fold lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 day absolute voice rest | Experimental | Behavioral: absolute voice restparticipants would begin initiation of voice/speaking 3 days post phonomicrosurgery for benign vocal fold lesions |
| 7 day absolute voice rest | Experimental | Behavioral: absolute voice restparticipants would begin initiation of voice/speaking 7 days post phonomicrosurgery for benign vocal fold lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with benign mid membranous vocal fold lesions such as the following:
- Undergoing elective phonomicrosurgery for vocal fold lesions, which involves microflap excision +/- truncation +/- steroid injection into the vocal folds.
- Age 18 and older
Key exclusion criteria (12 listed)
- Reinke's edema
- Active smokers
- Ligamentous mid membranous vocal fold lesions
- RRP (Recurrent Respiratory Papillomatosis)
- Dysplasia
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 |
|---|---|---|
| absolute voice restabsolute voice rest is the complete elimination of any vocalization (no sounds, speaking or whispering) | Behavioural | 3 day absolute voice rest, 7 day absolute voice rest |
Primary outcome
Voice Handicap Index - 10
Time frame: 3 months post op
Voice Handicap Index - 10
Time frame: 1 month post op
3 secondary outcomes
Cepstral Peak Prominence (CPP)
Time frame: 1 month and 3 months post op
Average phonatory airflow in all voiced sentence
Time frame: 1 month and 3 months post op
video stroboscopy findings
Time frame: 1 month and 3 months post op
Results and safety
The study was stopped early (reason given: Due to change in available resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: Yes. de-identified information with outside collaborators
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.
Libby Smith, DO principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing absolute voice rest in people with Benign Neoplasm of True Vocal Cords, run by University of Pittsburgh 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 15 Apr 2020. 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 was stopped early (reason given: Due to change in available resources). Results are not available in the source record.
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?
Voice Handicap Index - 10 (time frame: 3 months post op). The study lists 2 primary outcomes in all. 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 15 Apr 2020.