Vocal Fold NodulesNCT03416868

Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback

A study testing Ambulatory voice biofeedback in people with Vocal Fold Nodules and Muscle Tension Dysphonia, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Patients with vocal hyperfunction will undergo standard of care voice therapy with ambulatory voice monitoring before therapy and after the first 3 voice therapy sessions. Biofeedback will be added to ambulatory monitoring after the 2nd voice therapy session only. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Vocal Fold Nodules, Muscle Tension Dysphonia
What is being tested?: Ambulatory voice biofeedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2018to 5 Feb 2024
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with vocal fold nodules or muscle tension dysphonia undergoing voice therapy

Who cannot join

If a patient's baseline ambulatory monitoring data is not at least 1 standard deviation away from a normative database in any measure, he/she will be excluded. Non-English speakers are excluded because prompts on the smartphone app are only available in English.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction

Read the detailed description

This study will use a single subject design to determine if adding ambulatory voice biofeedback to conventional voice therapy can result in faster carryover (generalization) of new vocal behaviors established during voice therapy to daily life. Here, ambulatory voice biofeedback will be based on objective measures that have subject-specific sensitivity to vocal hyperfunction. Hypothesis: The ambulatory voice biofeedback week (week 2) will result in higher generalization percentages when compared to baseline and the week prior to the initiation of biofeedback (week 1). This effect will be retained when the biofeedback is removed (week 3), thus it will be different than baseline and week 1, but not different than week 2.

Conditions: Vocal Fold Nodules, Muscle Tension Dysphonia
Being tested: Ambulatory voice biofeedback
Keywords: Ambulatory, Biofeedback, Voice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ambulatory voice biofeedbackBehavioural
Patients will be provided cues regarding their vocal behavior in daily life. Specifically, the patient will receive 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly. The specific objective voice measure for biofeedback will depend upon which measure is most strongly associated with improvements during voice therapy.

Study groups in NCT03416868
Study group	Role	What they receive
Standard of care voice therapy with ambulatory voice biofeedback.	Experimental	Patients with Vocal Hyperfunction will undergo standard of care voice therapy, Ambulatory monitoring will be completed by the patients before therapy and throughout the first 3 weeks of therapy. Specifically, ambulatory monitoring will be worn by the patient for their 4 days with the most voicing during the first 3 weeks of therapy. Biofeedback will be activated only after the 2nd voice therapy session. Receives: Behavioral: Ambulatory voice biofeedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Compliance
Using a patient-specific voice measure, patients will be asked to avoid crossing numeric thresholds. The amount of voicing spent within desired thresholds will be the "percent compliance".
Measured: Week 1, Week 2, Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20185 Feb 2024

First posted31 Jan 2018
Study start1 Jun 2018
Primary completion25 Jan 2024
Study completion5 Feb 2024

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 Vocal Fold NodulesStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03416868
Sponsor's protocol ID: 2016P002849B
Other IDs: 1P50DC015446-01A1
Status last verified: Apr 2024
First submitted: 24 Jan 2018
Last updated: 17 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vocal Fold Nodules trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback in Small Groups of Patients With Vocal Hyperfunction
ClinicalTrials.gov ID: NCT03416868
Acronym / sponsor ID: 2016P002849B
Conditions: Vocal Fold Nodules, Muscle Tension Dysphonia
Keywords: Ambulatory, Biofeedback, Voice
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Study start: 1 Jun 2018 (actual)
Primary completion: 25 Jan 2024 (actual)
Study completion: 5 Feb 2024 (actual)
First posted: 31 Jan 2018 (actual)
Results: Posted 17 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Standard of care voice therapy with ambulatory voice biofeedback.	Experimental	Behavioral: Ambulatory voice biofeedbackPatients with Vocal Hyperfunction will undergo standard of care voice therapy, Ambulatory monitoring will be completed by the patients before therapy and throughout the first 3 weeks of therapy. Specifically, ambulatory monitoring will be worn by the patient for their 4 days with the most voicing during the first 3 weeks of therapy. Biofeedback will be activated only after the 2nd voice therapy session.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with vocal fold nodules or muscle tension dysphonia undergoing voice therapy

Key exclusion criteria (1 listed)

If a patient's baseline ambulatory monitoring data is not at least 1 standard deviation away from a normative database in any measure, he/she will be excluded. Non-English speakers are excluded because prompts on the smartphone app are only available in English.

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
Ambulatory voice biofeedbackPatients will be provided cues regarding their vocal behavior in daily life. Specifically, the patient will receive 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly. The specific objective voice measure for biofeedback will depend upon which measure is most strongly associated with improvements during voice therapy.	Behavioural	Standard of care voice therapy with ambulatory voice biofeedback.

Primary outcome

Percent Compliance
Time frame: Week 1, Week 2, Week 3
Using a patient-specific voice measure, patients will be asked to avoid crossing numeric thresholds. The amount of voicing spent within desired thresholds will be the "percent compliance".

Results and safety

Results posted to the registry on 17 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care Voice Therapy With Ambulatory Voice Biofeedback.	39	36

Primary outcome: Percent Compliance

Time frame: Week 1, Week 2, Week 3. Mean (Full Range). Unit: percentage of voicing crossing threshold

Measure	Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. n = 7
Week 1	89.04 (73.09 to 99.76)
Week 2	92.44 (84.7 to 99.08)
Week 3	90.76 (71.97 to 99.62)

Population analysed: There is a discrepancy in the numbers of enrolled patients here (total = 7) and compared to total enrolled (total = 39). This is because the first 32 patients' data were used to refine and adapt study protocols. The final 7 patients were acquired with this final protocol.

Adverse events

Time frame: Patients were involved in this study for 3 weeks and adverse event data (anterior neck skin irritation) were collected at the end of each week.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care Voice Therapy With Ambulatory Voice Biofeedback.	0 of 0	0 of 7 (0%)	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Vocal Fold Nodules

Not yet recruiting
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Project 4: Ambulatory Biofeedback and Voice Therapy for Patients With Vocal Hyperfunction
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Recruiting
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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.

Robert E Hillman, PhD principal investigator

Mass General Hospital, Harvard, MGH IHP

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ambulatory voice biofeedback in people with Vocal Fold Nodules and Muscle Tension Dysphonia, run by Massachusetts General Hospital 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 1 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 17 Apr 2024. 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 17 Apr 2024). 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?

Percent Compliance (time frame: Week 1, Week 2, Week 3). 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 NCT03416868.

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 17 Apr 2024.