Acute PhonotraumaPhase 1NCT01197339
Hybrid Model of Vocal Inflammation and Tissue Mobilization
A Phase 1 study testing resonant voice, voice rest and Breathy voice in people with Acute Phonotrauma, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to generate a technology that will allow clinicians to prescribe behavioral treatment that should optimize tissue healing for both acute and chronic phonotrauma. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Phonotrauma
- What is being tested?
- resonant voice, voice rest and Breathy voice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Mar 2013
- Phase
- Phase 1
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy females
- ages 18-40
- generally healthy
- normal hearing bilaterally at 20 dB to 8,000 Hz
- have ability to produce "resonant voice" during training as determined by the examiner perceptually
- Tolerate rigid and nasal endoscopy without anesthesia to the larynx nasal patency allowing for the passage of an endoscope unilaterally
Who cannot join
- Smoking within the past five yr
- Failing a hearing screening test
- Having current chronic voice problems
- Having current medications that are determined to possibly influence voice
- Having heightened gag reflex
- Having known or suspected allergy to anesthetics
- Pregnancy reported
Trial locations and contacts
1 site in 1 country.
United States1 site
Univesity of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
The purpose of this study is to generate a technology that will allow clinicians to prescribe behavioral treatment that should optimize tissue healing for both acute and chronic phonotrauma. In this study, we propose to (1): establish a non-invasive methodology for estimating overall mechanical dose during phonation, and component metrics of phonatory mechanical dose (e.g., distance dose, energy dissipation dose and time dose) from high speed imaging data and aeromechanical modeling, for a range of vocal fold configurations (Experiment 1); (2): identify mathematical relations between treatment dose parameters, inflammatory state of the tissue and time-varying biological consequences in the tissue, up to 2 wk following acute phonotrauma (Experiment 2); (3): develop a hybrid physical-biological model of vocal fold inflammation and treatment to identify treatment modalities that should optimize post-traumatic wound healing at 2 wk, for a range of acute phonotraumatic conditions (Experiment 3-no human subject involved), and (4): provide a preliminary test of the hybrid treatment models' ability to predict idealized treatment outcome in human subjects, and calibrate the model as needed iteratively to achieve a match between predicted and obtained outcomes (Experiment 4).
- Conditions
- Acute Phonotrauma
- Being tested
- resonant voice, voice rest, Breathy voice, Relaxation exercise, Resonant voice and relaxation exercise
- Keywords
- acute phonotrauma, computer modeling, resonant voice, breathy voice, voice rest, relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resonant voiceBehavioural
A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.
voice restBehavioural
A 4-hr voice rest will be prescribed to subjects following vocal loading.
Breathy voiceBehavioural
A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.
Relaxation exerciseBehavioural
Also called meditation
A 4-hr relaxation exercise will be prescribed to subjects following vocal loading.
Resonant voice and relaxation exerciseBehavioural
Also called Resonant voice and meditation exercise
A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Behavioral: resonant voice; Behavioral: Breathy voice; Behavioral: Relaxation exercise; Behavioral: Resonant voice and relaxation exercise |
| Controls | Sham comparator | Not described Receives: Behavioral: voice rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker levels in laryngeal secretion
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PhonotraumaStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), McGill University, Purdue University
- Responsible party
- Principal investigator, Kittie Verdolini Abbott, University of Pittsburgh
- Investigators
- Katherine Verdolini Abbott, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197339
- Sponsor's protocol ID
- DC008290
- Other IDs
- 5R01DC008290
- Status last verified
- Jan 2016
- First submitted
- 7 Sep 2010
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Li NY, Abbott KV, Rosen C, An G, Hebda PA, Vodovotz Y. Translational systems biology and voice pathophysiology. Laryngoscope. 2010 Mar;120(3):511-5. doi: 10.1002/lary.20755.
PubMed 20025041
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Model of Vocal Inflammation and Tissue Mobilization
- ClinicalTrials.gov ID
- NCT01197339
- Acronym / sponsor ID
- DC008290
- Conditions
- Acute Phonotrauma
- Keywords
- acute phonotrauma, computer modeling, resonant voice, breathy voice, voice rest, relaxation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), McGill University, Purdue University
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Sep 2010 (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.
The purpose of this study is to generate a technology that will allow clinicians to prescribe behavioral treatment that should optimize tissue healing for both acute and chronic phonotrauma. In this study, we propose to (1): establish a non-invasive methodology for estimating overall mechanical dose during phonation, and component metrics of phonatory mechanical dose (e.g., distance dose, energy dissipation dose and time dose) from high speed imaging data and aeromechanical modeling, for a range of vocal fold configurations (Experiment 1); (2): identify mathematical relations between treatment dose parameters, inflammatory state of the tissue and time-varying biological consequences in the tissue, up to 2 wk following acute phonotrauma (Experiment 2); (3): develop a hybrid physical-biological model of vocal fold inflammation and treatment to identify treatment modalities that should optimize post-traumatic wound healing at 2 wk, for a range of acute phonotraumatic conditions (Experiment 3-no human subject involved), and (4): provide a preliminary test of the hybrid treatment models' ability to predict idealized treatment outcome in human subjects, and calibrate the model as needed iteratively to achieve a match between predicted and obtained outcomes (Experiment 4).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Behavioral: resonant voice, Behavioral: Breathy voice, Behavioral: Relaxation exercise, Behavioral: Resonant voice and relaxation exercise |
| Controls | Sham comparator | Behavioral: voice rest |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy females
- ages 18-40
- generally healthy
- normal hearing bilaterally at 20 dB to 8,000 Hz
- have ability to produce "resonant voice" during training as determined by the examiner perceptually
Key exclusion criteria (7 listed)
- Smoking within the past five yr
- Failing a hearing screening test
- Having current chronic voice problems
- Having current medications that are determined to possibly influence voice
- Having heightened gag reflex
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 |
|---|---|---|
| resonant voiceA 4-hr resonant voice exercise will be prescribed to subjects following vocal loading. | Behavioural | treatment |
| voice restA 4-hr voice rest will be prescribed to subjects following vocal loading. | Behavioural | Controls |
| Breathy voiceA 4-hr breathy voice exercise will be prescribed to subjects following vocal loading. | Behavioural | treatment |
| Relaxation exerciseAlso: meditationA 4-hr relaxation exercise will be prescribed to subjects following vocal loading. | Behavioural | treatment |
| Resonant voice and relaxation exerciseAlso: Resonant voice and meditation exerciseA 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading. | Behavioural | treatment |
Primary outcome
Biomarker levels in laryngeal secretion
Time frame: up to 2 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 25 Jan 2016.
- Results publication: PubMed 20025041Li NY, Abbott KV, Rosen C, An G, Hebda PA, Vodovotz Y. Translational systems biology and voice pathophysiology. Laryngoscope. 2010 Mar;120(3):511-5. doi: 10.1002/lary.20755.
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.
Katherine Verdolini Abbott, Ph.D. 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 Phase 1 study testing resonant voice, voice rest and Breathy voice in people with Acute Phonotrauma, 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 7 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 25 Jan 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Biomarker levels in laryngeal secretion (time frame: up to 2 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 NCT01197339, which also lists 1 linked publication.
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 25 Jan 2016.