Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03416868 |
Other study ID # |
2016P002849B |
Secondary ID |
1P50DC015446-01A |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 1, 2018 |
Est. completion date |
February 5, 2024 |
Study information
Verified date |
April 2024 |
Source |
Massachusetts General Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.