HealthyNCT03762993
Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults
A study of Healthy, run by Purdue University at 1 site in United States.
Trial summary
The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- within age range
Who cannot join
- Voice Disorders
- Strong gag reflex
- Craniofacial disorders
- Cognitive Impairments
- Head and Neck Cancer
- Hearing Difficulties
- Dentition problems that prevent an oral scope being placed in mouth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vocal Restoration Programs After Acute Vocal Exertion
The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. This study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. The investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.
- Conditions
- Healthy
- Being tested
- Vocal rest and Controlled Phonation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocal rest and Controlled PhonationBehavioural
Voice rest and semi occluded vocal tract voice exercises
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Experimental | Participants will complete vocal rest and controlled phonation Receives: Behavioral: Vocal rest and Controlled Phonation |
| Healthy Adults reporting Vocal Fatigue | Experimental | Participants will complete vocal rest and controlled phonation Receives: Behavioral: Vocal rest and Controlled Phonation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phonation Threshold Pressure
Minimum air pressure required to initiate and sustain vocal fold oscillation
Measured: 2.5 hours
Secondary outcomes (1)
Lung Volume Excursion
The difference between lung volume initiation and termination on connected speech
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start5 Dec 2018
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Within Subject Design
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Preeti M. Sivasankar, Purdue University
- Investigators
- Preeti Sivasankar, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762993
- Sponsor's protocol ID
- Vocal restoration programs
- Status last verified
- Aug 2021
- First submitted
- 30 Nov 2018
- Last updated
- 5 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vocal Restoration Programs After Acute Vocal Exertion
- ClinicalTrials.gov ID
- NCT03762993
- Acronym / sponsor ID
- Vocal restoration programs
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Posted 5 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. This study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. The investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within Subject Design
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | Experimental | Behavioral: Vocal rest and Controlled PhonationParticipants will complete vocal rest and controlled phonation |
| Healthy Adults reporting Vocal Fatigue | Experimental | Behavioral: Vocal rest and Controlled PhonationParticipants will complete vocal rest and controlled phonation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- within age range
Key exclusion criteria (7 listed)
- Voice Disorders
- Strong gag reflex
- Craniofacial disorders
- Cognitive Impairments
- Head and Neck Cancer
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 |
|---|---|---|
| Vocal rest and Controlled PhonationVoice rest and semi occluded vocal tract voice exercises | Behavioural | Healthy Adults, Healthy Adults reporting Vocal Fatigue |
Primary outcome
Phonation Threshold Pressure
Time frame: 2.5 hours
Minimum air pressure required to initiate and sustain vocal fold oscillation
1 secondary outcome
Lung Volume Excursion
Time frame: 2.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Preeti Sivasankar principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy, run by Purdue University 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 1 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 5 Aug 2021. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phonation Threshold Pressure (time frame: 2.5 hours). 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 5 Aug 2021.