DysphoniaNCT02922309
Comparing Telepractice and Conventional Face-to-face Voice Therapy
A study testing Vocal Training Via Telepractice and Vocal Training Via face-to face practice in people with Dysphonia and Aged, run by Far Eastern Memorial Hospital.
Trial summary
People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. However, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dysphonia, Aged, Speech Therapy
- What is being tested?
- Vocal Training Via Telepractice and Vocal Training Via face-to face practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2016to 19 Dec 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient equal or older than 55 years old
- Voice Handicap Index-10 (VHI-10) score >10 point
- accessibility to a network connection
Who cannot join
- neurologic disorders
- active pulomanory disease
- mental disorder
About this study
Official title: Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-face Therapy
People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. However, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus reduces treatment effects. The purpose of the study is to design a telecommunication vocal training system and a vocal training program for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study, including a single-blind, randomized controlled trial, to test the hypothesis that vocal training via telepractice for voice disordered elderly are not inferior to the standard face to face training.
Read the detailed description
Randomization: per mutated block, 40 patients on each arms (experimental and control)
Allocation: sealed envelope indicating either of the 2 groups
Intervention: weekly vocal training, each course last for 30-40 minutes,lasting for 2 months
Outcome measurement: before treatment, 1 month, 3 months, and 6 months after treatment
Primary outcome: 10-item voice handicap index
Secondary outcome: acoustics and aerodynamic parameter
- Conditions
- Dysphonia, Aged, Speech Therapy
- Being tested
- Vocal Training Via Telepractice, Vocal Training Via face-to face practice
- Medical subject headings
- Dysphonia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocal Training Via TelepracticeBehavioural
Vocal Training Via Telepractice, delivered by integrated communication service
Vocal Training Via face-to face practiceBehavioural
Vocal Training Via face-to face practice at medical facilities
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Vocal Training via Telepractice Receives: Behavioral: Vocal Training Via Telepractice |
| control | Active comparator | Vocal Training via face-to-face practice Receives: Behavioral: Vocal Training Via face-to face practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of 10-item voice handicap index at 2 months
min: 0(best); Max: 40(worst);
Measured: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start17 Oct 2016
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
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 DysphoniaStudies 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
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Te Wang, Far Eastern Memorial Hospital
- Investigators
- Chi-Te Wang, MD, PhD, Principal investigator, Department of Otolaryngology, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922309
- Sponsor's protocol ID
- FEMH-IRB-104193-E
- Status last verified
- Feb 2020
- First submitted
- 23 Sep 2016
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lin FC, Chien HY, Chen SH, Kao YC, Cheng PW, Wang CT. Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-Face Therapy. J Speech Lang Hear Res. 2020 Jul 20;63(7):2132-2140. doi: 10.1044/2020_JSLHR-19-00364. Epub 2020 Jun 24.
PubMed 32579859
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-face Therapy
- ClinicalTrials.gov ID
- NCT02922309
- Acronym / sponsor ID
- FEMH-IRB-104193-E
- Conditions
- Dysphonia, Aged, Speech Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 4 Oct 2016 (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.
People over 55 years are high-risk with voice disorders. Voice disordered elderly need vocal training in order to improve communication efficiency and quality of life. However, participation in vocal training of elderly is often restricted by motivation, time of practice, and availability to hospital, which thus reduces treatment effects. The purpose of the study is to design a telecommunication vocal training system and a vocal training program for voice disordered elderly in Taiwan. The investigator proposed a 3-year consecutive study, including a single-blind, randomized controlled trial, to test the hypothesis that vocal training via telepractice for voice disordered elderly are not inferior to the standard face to face training.
Detailed description
Randomization: per mutated block, 40 patients on each arms (experimental and control)
Allocation: sealed envelope indicating either of the 2 groups
Intervention: weekly vocal training, each course last for 30-40 minutes,lasting for 2 months
Outcome measurement: before treatment, 1 month, 3 months, and 6 months after treatment
Primary outcome: 10-item voice handicap index
Secondary outcome: acoustics and aerodynamic parameter
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Vocal Training Via TelepracticeVocal Training via Telepractice |
| control | Active comparator | Behavioral: Vocal Training Via face-to face practiceVocal Training via face-to-face practice |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient equal or older than 55 years old
- Voice Handicap Index-10 (VHI-10) score >10 point
- accessibility to a network connection
Key exclusion criteria (3 listed)
- neurologic disorders
- active pulomanory disease
- mental disorder
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 Training Via TelepracticeVocal Training Via Telepractice, delivered by integrated communication service | Behavioural | experimental |
| Vocal Training Via face-to face practiceVocal Training Via face-to face practice at medical facilities | Behavioural | control |
Primary outcome
Change from Baseline of 10-item voice handicap index at 2 months
Time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy
min: 0(best); Max: 40(worst);
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 26 Feb 2020.
- Derived from this study: PubMed 32579859Lin FC, Chien HY, Chen SH, Kao YC, Cheng PW, Wang CT. Voice Therapy for Benign Voice Disorders in the Elderly: A Randomized Controlled Trial Comparing Telepractice and Conventional Face-to-Face Therapy. J Speech Lang Hear Res. 2020 Jul 20;63(7):2132-2140. doi: 10.1044/2020_JSLHR-19-00364. Epub 2020 Jun 24.
- 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.
Chi-Te Wang, MD, PhD principal investigator
Department of Otolaryngology, Far Eastern Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Vocal Training Via Telepractice and Vocal Training Via face-to face practice in people with Dysphonia and Aged, run by Far Eastern Memorial Hospital.
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 3 inclusion and 3 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline of 10-item voice handicap index at 2 months (time frame: before treatment (after signing informed consent, prior to randomization) and within 2 weeks after the completion of voice therapy). 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 NCT02922309, 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 26 Feb 2020.