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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50DC015446-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100% frequency | Experimental | 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. |
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| 25% frequency | Experimental | 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. |
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| Summary feedback | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory voice biofeedback | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Robert E Hillman, PhD | Mass General Hospital, Harvard, MGH IHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital - Center for Laryngeal Surgery and Voice Rehabilitation | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Percentage of voicing below a threshold | 1 week |
2 weeks
This is a low-risk clinical trial, as determined by the IRB. We will collect data only on Other Adverse Events, specifically patient-reported skin irritation where the monitor's sensor was taped to the neck during wear. Specifically, each patient will be systematically assessed for skin irritation by the investigator asking the patient if any skin irritation occurred at the end of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jarrad H Van Stan | Massachusetts General Hospital | 617-643-8410 | jvanstan@mghihp.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2022 | Aug 22, 2022 | Prot_SAP_000.pdf |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Percentage of voicing below threshold | Mean | Standard Deviation | Percentage of voicing below threshold |
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| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
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| 0 |
| 10 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 10 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 9 |
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