Acute PhonotraumaNCT01009632
Role of Exercise for Wound Healing in the Larynx
A study testing Resonant voice, Voice rest and Spontaneous speech 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 explore quantitatively the hypothesis that "resonant voice," may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Phonotrauma
- What is being tested?
- Resonant voice, Voice rest and Spontaneous speech
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Mar 2005
- 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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- males and females who have had voice training and feel they are able to produce loud voice safely;
- ages 18-49;
- generally healthy;
- normal hearing bilaterally at 20 dB to 8,000 Hz; and
- demonstrated ability to produce "resonant voice" during training as determined by the examiner perceptually.
Who cannot join
- current chronic voice problems;
- current medications that are determined to possibly influence voice (e.g. diuretics, decongestants);
- heightened gag reflex;
- small nasal passage;
- deviated septum; and
- known or suspected allergy to anesthetics.
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 explore quantitatively the hypothesis that "resonant voice," may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests.
Read the detailed description
The objective is to use the following operationalized question: Does a voicing mode shown to correspond to high-amplitude, low impact vocal cord oscillations, "resonant voice," improve the amount and time-course of recovery from acute phonotrauma, compared to vocal rest or spontaneous speech, as measured with molecular assays (primarily) and with behavioral and clinical tests (secondarily)?
- Conditions
- Acute Phonotrauma
- Being tested
- Resonant voice, Voice rest, Spontaneous speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonant voiceBehavioural
4-hr of resonant voice exercise
Voice restBehavioural
4-hr of complete refrain from any voice use
Spontaneous speechBehavioural
Also called 4-hr of conversational (normal) voice use
| Study group | Role | What they receive |
|---|---|---|
| Voice rest | Experimental | Not described Receives: Behavioral: Voice rest |
| Resonant voice exercise | Experimental | Not described Receives: Behavioral: Resonant voice |
| Spontaneous speech | Experimental | Not described Receives: Behavioral: Spontaneous speech |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers in laryngeal secretions
Measured: Up to 24-hour post-baseline
Secondary outcomes (3)
Phonation Threshold Pressure (PTP)
Measured: Up to 24-hour post baseline
Direct Magnitude Estimations of phonatory effort (DME)
Measured: Up to 24-hour post baseline
Visual-perceptual ratings of the larynx
Measured: Up to 24-hour post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startFeb 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Katherine Verdolini Abbott, Ph.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009632
- Sponsor's protocol ID
- DC005643
- Status last verified
- Nov 2009
- First submitted
- 5 Nov 2009
- Last updated
- 9 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Exercise for Wound Healing in the Larynx
- ClinicalTrials.gov ID
- NCT01009632
- Acronym / sponsor ID
- DC005643
- Conditions
- Acute Phonotrauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 9 Nov 2009 (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 explore quantitatively the hypothesis that "resonant voice," may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests.
Detailed description
The objective is to use the following operationalized question: Does a voicing mode shown to correspond to high-amplitude, low impact vocal cord oscillations, "resonant voice," improve the amount and time-course of recovery from acute phonotrauma, compared to vocal rest or spontaneous speech, as measured with molecular assays (primarily) and with behavioral and clinical tests (secondarily)?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Voice rest | Experimental | Behavioral: Voice rest |
| Resonant voice exercise | Experimental | Behavioral: Resonant voice |
| Spontaneous speech | Experimental | Behavioral: Spontaneous speech |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- males and females who have had voice training and feel they are able to produce loud voice safely;
- ages 18-49;
- generally healthy;
- normal hearing bilaterally at 20 dB to 8,000 Hz; and
- demonstrated ability to produce "resonant voice" during training as determined by the examiner perceptually.
Key exclusion criteria (6 listed)
- current chronic voice problems;
- current medications that are determined to possibly influence voice (e.g. diuretics, decongestants);
- heightened gag reflex;
- small nasal passage;
- deviated septum; and
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 voice4-hr of resonant voice exercise | Behavioural | Resonant voice exercise |
| Voice rest4-hr of complete refrain from any voice use | Behavioural | Voice rest |
| Spontaneous speechAlso: 4-hr of conversational (normal) voice use | Behavioural | Spontaneous speech |
Primary outcome
Biomarkers in laryngeal secretions
Time frame: Up to 24-hour post-baseline
3 secondary outcomes
Phonation Threshold Pressure (PTP)
Time frame: Up to 24-hour post baseline
Direct Magnitude Estimations of phonatory effort (DME)
Time frame: Up to 24-hour post baseline
Visual-perceptual ratings of the larynx
Time frame: Up to 24-hour post baseline
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 9 Nov 2009.
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 study testing Resonant voice, Voice rest and Spontaneous speech 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 5 inclusion and 6 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 9 Nov 2009. 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?
Biomarkers in laryngeal secretions (time frame: Up to 24-hour post-baseline). 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 9 Nov 2009.