Trial Outcomes & Findings for Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback (NCT NCT03416868)
NCT ID: NCT03416868
Last Updated: 2024-04-17
Results Overview
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".
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Week 1, Week 2, Week 3
Results posted on
2024-04-17
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Preliminary Study 2 to Test the Effects of Ambulatory Voice Biofeedback
Baseline characteristics by cohort
| Measure |
Standard of Care Voice Therapy With Ambulatory Voice Biofeedback.
n=7 Participants
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.
|
|---|---|
|
Age, Continuous
|
35 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Percent compliance
|
89.46 Percentage of voicing below threshold
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 2, Week 3Population: 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.
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".
Outcome measures
| Measure |
Standard of Care Voice Therapy With Ambulatory Voice Biofeedback.
n=7 Participants
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.
|
|---|---|
|
Percent Compliance
Week 1
|
89.04 percentage of voicing crossing threshold
Interval 73.09 to 99.76
|
|
Percent Compliance
Week 2
|
92.44 percentage of voicing crossing threshold
Interval 84.7 to 99.08
|
|
Percent Compliance
Week 3
|
90.76 percentage of voicing crossing threshold
Interval 71.97 to 99.62
|
Adverse Events
Standard of Care Voice Therapy With Ambulatory Voice Biofeedback.
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 Van Stan, PhD, CCC-SLP
Massachusetts General Hospital; Harvard Medical School
Phone: 617-643-8410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place