An interventional study of Ambulatory voice biofeedback in Vocal Fold Nodules and Muscle Tension Dysphonia, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
Among 71 studies in Dysphonia with a site in United States — 20 open to participants now, 21 under way, 1 of them phase 3. Dysphonia · United States.
Among the 71 studies in Dysphonia with a site in United States, this one is the 24th largest by enrollment of the 53 interventional ones, is one of 3 that started in 2018, is one of 31 with no phase, and was the 30th registered.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's enrollment of 39 is above the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →20 of the 71 studies in Dysphonia with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 25 Dysphonia studies recruiting now, 8 (32%) set no upper age limit and 9 (36%) stop at 75 or younger; 7 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →71 studies; the count open now beside each. This study's row is marked.
First in 1992; this study’s year is marked. 3 started in 2018.
Median enrollment 32 across the 53 interventional studies, 170 across the 18 observational. Of the 41 that completed or were terminated, 17 (41%) have results posted.
2 of 71 have an industry lead sponsor. The 10 most frequent:
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Massachusetts General Hospital has 2 studies filed under Dysphonia — fewer than ten, so there is no comparison to draw.
12 of the studies in Dysphonia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07145086Phase 3Texas Christian UniversityTranslaryngeal Vibration for Hyperfunctional Voice Disorders | 2027-04-30 |
| NCT06830174Yale UniversitytDCS for Laryngeal Dystonia | 2026-12 |
| NCT03702322University of ArizonaImproving Voice Production for Adults With Age-related Dysphonia | 2026-12-30 |
| NCT05095740MGH Institute of Health ProfessionsEffects of Neuromodulation in Laryngeal Dystonia | 2026-12-31 |
| NCT07443891University of MinnesotaBrain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia | 2027-02-28 |
Among the 71 studies in Dysphonia with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Ambulatory voice biofeedback
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.
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".
Time frame: Week 1, Week 2, Week 3
| Milestone | Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. |
|---|---|
| Started | 39 |
| Completed | 36 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Lost to follow-up | 1 |
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".
| percentage of voicing crossing threshold | Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. |
|---|---|
| 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) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. | — | — | 0/7 (0%) |
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.
| Age, Continuous(years) | Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. |
|---|---|
| Mean | 35 (18 to 57) |
| Sex: Female, Male(Participants) | Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. |
|---|---|
| Female | 6 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 6 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Percent compliance(Percentage of voicing below threshold) | Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. |
|---|---|
| Mean | 89.46 (78.23 to 98.67) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Jan 2024, 67 months.
Results were first posted in Apr 2024, 2 months after primary completion.
Of 44 non-industry interventional studies with no phase under Dysphonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 67 months is above that.
Counting every sponsor, half of 44 studies reached it within 26 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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