Voice DisordersNCT04002336
Testing a Smart Phone App to Enhance Voice Therapy Adherence
A study testing Traditional Voice therapy and Voice Therapy App in people with Voice Disorders, run by Vrushali Angadi at 1 site in United States.
Trial summary
The current project is designed as phase 1 study conducted to improve/enhance normal voice. Fifteen Thirty non-treatment seeking individuals, with no identifiable vocal pathology on laryngeal examination, will be randomized to one of two groups; 1) Voice therapy delivery without App (control/standard of care), 2)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders
- What is being tested?
- Traditional Voice therapy and Voice Therapy App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Nov 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults > 18 years
- Non-smokers
- Hearing level within normal limits
- Absence of vocal fold pathology as confirmed by MD on laryngeal examination
- Agree to avoid vocally abusive behaviors for the entirety of the study
Who cannot join
- Apple phone (iOS)
- Impaired hearing
- Uncontrolled asthma
- Smoking
- H/o vocal fold surgery
- Presence of vocal fold pathology
- Previous history of experience with VFE performance
- Non-English speaking participants
Trial locations and contacts
1 site in 1 country.
About this study
The current project is designed as phase 1 study conducted to improve/enhance normal voice. Fifteen Thirty non-treatment seeking individuals, with no identifiable vocal pathology on laryngeal examination, will be randomized to one of two groups; 1) Voice therapy delivery without App (control/standard of care), 2) Voice therapy delivery with app (experimental). Participants in both groups will attend weekly voice therapy sessions (for 6 weeks) with the PI and Co- I (Joseph Stemple). Control group participants will be provided with an audio file of the exercises, and an exercise log sheet to track progress. Experimental group participants will use the smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track. Three-wave surveys will be conducted at the baseline, four weeks and 6 weeks after the intervention. Other data sources include study administration, exercise logs, app data, and clinical assessment.
- Conditions
- Voice Disorders
- Being tested
- Traditional Voice therapy, Voice Therapy App
- Keywords
- adherence
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Voice therapyBehavioural
Also called Vocal Function Exercises
Traditional method of voice therapy
Voice Therapy AppBehavioural
Also called Vocal Function Exercises
Smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Voice Therapy | Active comparator | Standard of care (traditional) voice therapy. Receives: Behavioral: Traditional Voice therapy |
| App Group | Experimental | Voice therapy using a smartphone app. Receives: Behavioral: Voice Therapy App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Number of completed home practice sessions
Measured: 6 weeks
Secondary outcomes (1)
MPT (maximum phonation time)
Maximum phonation time
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Oct 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrushali Angadi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vrushali Angadi, University of Kentucky
- Investigators
- Vrushali Angadi, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002336
- Sponsor's protocol ID
- 44183
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- 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 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Smart Phone App to Enhance Voice Therapy Adherence
- ClinicalTrials.gov ID
- NCT04002336
- Acronym / sponsor ID
- 44183
- Conditions
- Voice Disorders
- Keywords
- adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Vrushali AngadiUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 28 Jun 2019 (actual)
- 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 current project is designed as phase 1 study conducted to improve/enhance normal voice. Fifteen Thirty non-treatment seeking individuals, with no identifiable vocal pathology on laryngeal examination, will be randomized to one of two groups; 1) Voice therapy delivery without App (control/standard of care), 2) Voice therapy delivery with app (experimental). Participants in both groups will attend weekly voice therapy sessions (for 6 weeks) with the PI and Co- I (Joseph Stemple). Control group participants will be provided with an audio file of the exercises, and an exercise log sheet to track progress. Experimental group participants will use the smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track. Three-wave surveys will be conducted at the baseline, four weeks and 6 weeks after the intervention. Other data sources include study administration, exercise logs, app data, and clinical assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Voice Therapy | Active comparator | Behavioral: Traditional Voice therapyStandard of care (traditional) voice therapy. |
| App Group | Experimental | Behavioral: Voice Therapy AppVoice therapy using a smartphone app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults > 18 years
- Non-smokers
- Hearing level within normal limits
- Absence of vocal fold pathology as confirmed by MD on laryngeal examination
- Agree to avoid vocally abusive behaviors for the entirety of the study
Key exclusion criteria (8 listed)
- Apple phone (iOS)
- Impaired hearing
- Uncontrolled asthma
- Smoking
- H/o vocal fold surgery
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 |
|---|---|---|
| Traditional Voice therapyAlso: Vocal Function ExercisesTraditional method of voice therapy | Behavioural | Traditional Voice Therapy |
| Voice Therapy AppAlso: Vocal Function ExercisesSmartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track. | Behavioural | App Group |
Primary outcome
Adherence
Time frame: 6 weeks
Number of completed home practice sessions
1 secondary outcome
MPT (maximum phonation time)
Time frame: 6 weeks
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 28 Jun 2019.
- 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.
Vrushali Angadi principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Voice therapy and Voice Therapy App in people with Voice Disorders, run by Vrushali Angadi 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 8 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 28 Jun 2019. 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?
Adherence (time frame: 6 weeks). 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 28 Jun 2019.