Vocal Fold Nodules
Conditions
Keywords
Ambulatory, Biofeedback, Voice
Brief summary
This first study will enroll 3 groups of patients with vocal fold nodules that will receive different schedules of ambulatory voice biofeedback (100% frequency feedback, 25% frequency feedback, summary feedback) to avoid their upper 15th percentile of vocal loudness.
Detailed description
We will conduct this study (based on principles of motor learning) using novel smartphone-based ambulatory voice biofeedback systems aimed at improving the carryover of newly established vocal behaviors into daily life. This first study will determine which of three types of ambulatory feedback results in better learning/retention (100% frequency, 25% frequency, or delayed summary feedback every 2 minutes of voicing) of a new vocal behavior (reduced vocal intensity) in three groups of 15 patients with vocal fold nodules. Hypothesis: Patients receiving lower frequency or summary feedback will produce lower initial performance but higher short- and long-term retention than patients receiving feedback 100% of the time.
Interventions
BEHAVIORALAmbulatory voice biofeedback
Subjects will be provided cues regarding their vocal behavior in daily life. The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
Exclusion criteria
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 | 1 week | Percentage compliance is the amount of voiced time patients spent below their biofeedback threshold divided by the total amount of voiced time. Each patient's biofeedback threshold was individually established as their 85th percentile of vocal intensity. Patients were asked to avoid loud voicing, i.e., anything at their 85th percentile or higher. During biofeedback, patients were cued every time (100% frequency) or every 4th time (25% frequency) the voiced louder than their 85th percentile; or provided summary information (their percentage compliance) after every 2 minutes of voicing (summary feedback). During short-term retention monitoring, patients were asked to not voice loud (over or equal to 85th percentile) the next day and the biofeedback was turned off. During long-term retention monitoring, patients were asked to not voice loud one week later without biofeedback. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 100% Frequency Some patients will be assigned (via block randomization) to receive ambulatory voice biofeedback (100% frequency - vibrotactile cueing every time the participant exceeds a vocal intensity threshold). Voice monitoring will be conducted for 3 days (device automatically turns off after 42 minutes of voicing): Day 1: biofeedback will be active all day , Day 2: the day after Day 1, no biofeedback, just monitoring to test short-term retention. Day 3: 7 days post-Day 1, no biofeedback, just monitoring to test longer-term retention.
Ambulatory voice biofeedback: Subjects will be provided cues regarding their vocal behavior in daily life. The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing. | 10 |
| 25% Frequency Some patients will be assigned (via block randomization) to receive ambulatory voice biofeedback (25% frequency - vibrotactile cueing every 4th time the participant exceeds a vocal intensity threshold). Voice monitoring will be conducted for 3 days (device automatically turns off after 42 minutes of voicing): Day 1: biofeedback will be active all day , Day 2: the day after Day 1, no biofeedback, just monitoring to test short-term retention. Day 3: 7 days post-Day 1, no biofeedback, just monitoring to test longer-term retention.
Ambulatory voice biofeedback: Subjects will be provided cues regarding their vocal behavior in daily life. The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing. | 10 |
| Summary Feedback Some patients will be assigned (via block randomization) to receive ambulatory voice biofeedback (summary - no cueing, statistics shown every 2 minutes of voicing). Voice monitoring will be conducted for 3 days (device automatically turns off after 42 minutes of voicing): Day 1: biofeedback will be active all day , Day 2: the day after Day 1, no biofeedback, just monitoring to test short-term retention. Day 3: 7 days post-Day 1, no biofeedback, just monitoring to test longer-term retention.
Ambulatory voice biofeedback: Subjects will be provided cues regarding their vocal behavior in daily life. The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing. | 9 |
| Total | 29 |
Baseline characteristics
| Characteristic | 100% Frequency | 25% Frequency | Summary Feedback | Total |
|---|---|---|---|---|
| Age, Continuous | 25 years STANDARD_DEVIATION 13 | 24 years STANDARD_DEVIATION 8 | 25 years STANDARD_DEVIATION 10 | 25 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 8 Participants | 7 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Percentage of voicing below threshold | 85 Percentage of voicing below threshold STANDARD_DEVIATION 5.97 | 85 Percentage of voicing below threshold STANDARD_DEVIATION 3.21 | 84.75 Percentage of voicing below threshold STANDARD_DEVIATION 5.81 | 84.92 Percentage of voicing below threshold STANDARD_DEVIATION 4.89 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 9 Participants | 6 Participants | 21 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 9 participants | 29 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 9 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percent Compliance
Percentage compliance is the amount of voiced time patients spent below their biofeedback threshold divided by the total amount of voiced time. Each patient's biofeedback threshold was individually established as their 85th percentile of vocal intensity. Patients were asked to avoid loud voicing, i.e., anything at their 85th percentile or higher. During biofeedback, patients were cued every time (100% frequency) or every 4th time (25% frequency) the voiced louder than their 85th percentile; or provided summary information (their percentage compliance) after every 2 minutes of voicing (summary feedback). During short-term retention monitoring, patients were asked to not voice loud (over or equal to 85th percentile) the next day and the biofeedback was turned off. During long-term retention monitoring, patients were asked to not voice loud one week later without biofeedback.
Time frame: 1 week
Population: There is a discrepancy in the numbers of enrolled patients here (total = 13) and in previous sections (total = 31). This is because the first 18 patients data were used to refine and adapt study protocols. The final 13 patients data were acquired with this final protocol and we are reporting those data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 100% Frequency | Percent Compliance | Short-term Retention | 96.08 Percentage of voicing below a threshold | Standard Deviation 2.26 |
| 100% Frequency | Percent Compliance | Biofeedback | 97.38 Percentage of voicing below a threshold | Standard Deviation 3.72 |
| 100% Frequency | Percent Compliance | Long-term Retention | 90.76 Percentage of voicing below a threshold | Standard Deviation 9.29 |
| 25% Frequency | Percent Compliance | Short-term Retention | 88.86 Percentage of voicing below a threshold | Standard Deviation 10.14 |
| 25% Frequency | Percent Compliance | Biofeedback | 95.11 Percentage of voicing below a threshold | Standard Deviation 3 |
| 25% Frequency | Percent Compliance | Long-term Retention | 88.39 Percentage of voicing below a threshold | Standard Deviation 7.43 |
| Summary Feedback | Percent Compliance | Biofeedback | 94.44 Percentage of voicing below a threshold | Standard Deviation 2.46 |
| Summary Feedback | Percent Compliance | Long-term Retention | 90.25 Percentage of voicing below a threshold | Standard Deviation 4.89 |
| Summary Feedback | Percent Compliance | Short-term Retention | 90.48 Percentage of voicing below a threshold | Standard Deviation 5.53 |