Trial Outcomes & Findings for Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback (NCT NCT03416829)

Last Updated: 2022-11-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

29 participants

Primary outcome timeframe

1 week

Results posted on

2022-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	10	10	9
Overall Study COMPLETED	10	10	9
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preliminary Study 1 to Test the Effects of Ambulatory Voice Biofeedback

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	100% Frequency n=4 Participants 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.	25% Frequency n=5 Participants 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.	Summary Feedback n=4 Participants 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.
Percent Compliance Biofeedback	97.38 Percentage of voicing below a threshold Standard Deviation 3.72	95.11 Percentage of voicing below a threshold Standard Deviation 3.00	94.44 Percentage of voicing below a threshold Standard Deviation 2.46
Percent Compliance Short-term Retention	96.08 Percentage of voicing below a threshold Standard Deviation 2.26	88.86 Percentage of voicing below a threshold Standard Deviation 10.14	90.48 Percentage of voicing below a threshold Standard Deviation 5.53
Percent Compliance Long-term Retention	90.76 Percentage of voicing below a threshold Standard Deviation 9.29	88.39 Percentage of voicing below a threshold Standard Deviation 7.43	90.25 Percentage of voicing below a threshold Standard Deviation 4.89

Adverse Events

100% Frequency

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

25% Frequency

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Summary Feedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jarrad H Van Stan

Massachusetts General Hospital

Phone: 617-643-8410

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	100% Frequency n=10 Participants 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.	25% Frequency n=10 Participants 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.	Summary Feedback n=9 Participants 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.	Total n=29 Participants Total of all reporting groups
Age, Continuous	25 years STANDARD_DEVIATION 13 • n=5 Participants	24 years STANDARD_DEVIATION 8 • n=7 Participants	25 years STANDARD_DEVIATION 10 • n=5 Participants	25 years STANDARD_DEVIATION 10 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	25 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	9 participants n=5 Participants	29 participants n=4 Participants
Percentage of voicing below threshold	85 Percentage of voicing below threshold STANDARD_DEVIATION 5.97 • n=5 Participants	85 Percentage of voicing below threshold STANDARD_DEVIATION 3.21 • n=7 Participants	84.75 Percentage of voicing below threshold STANDARD_DEVIATION 5.81 • n=5 Participants	84.92 Percentage of voicing below threshold STANDARD_DEVIATION 4.89 • n=4 Participants