Muscle Tension Dysphonia, Vocal Fold Nodules
Conditions
Keywords
Ambulatory, Biofeedback, Voice
Brief 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.
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.
Interventions
BEHAVIORALAmbulatory 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.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with vocal fold nodules or muscle tension dysphonia undergoing voice therapy
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Compliance | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. 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.
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. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. |
|---|---|
| Age, Continuous | 35 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Percent compliance | 89.46 Percentage of voicing below threshold |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. | Percent Compliance | Week 1 | 89.04 percentage of voicing crossing threshold |
| Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. | Percent Compliance | Week 2 | 92.44 percentage of voicing crossing threshold |
| Standard of Care Voice Therapy With Ambulatory Voice Biofeedback. | Percent Compliance | Week 3 | 90.76 percentage of voicing crossing threshold |