Trial Outcomes & Findings for Vestibular Rehabilitation and Otolith Dysfunction (NCT NCT02652442)
NCT ID: NCT02652442
Last Updated: 2021-11-04
Results Overview
Static subjective visual vertical (SVV) assesses spatial perception and is influenced by otolith function. Perception of vertical is measured in a darkened room with subject seated upright. The test assesses an individual's ability to adjust a laser line to be parallel with true vertical in the absence of any other visual cues. The start position of line for SVV testing is randomized and participants are instructed to use the track ball to position the line in a vertical position. Five trials are completed, and the software calculates the distance (in degrees) from vertical. The average of the trials is calculated and used for data analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
baseline, immediately after 5 sessions of OAR training (1 week)
Results posted on
2021-11-04
Participant Flow
Participant milestones
| Measure |
Centrifugation
Each subject will complete training at 3.5 cm off-axis. Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis. Subjects will have a wash out period of at least 2 weeks in between chair training distance (3.5 cm or 7.0 cm) until static SVV returns to normal. Then subjects will complete training at 7.0 cm off-axis. Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis.
Participants will receive 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo will be assessed at the start and end of each session.
|
|---|---|
|
Centrifugation - Distance
STARTED
|
6
|
|
Centrifugation - Distance
COMPLETED
|
5
|
|
Centrifugation - Distance
NOT COMPLETED
|
1
|
|
Centrifugation - Duration
STARTED
|
5
|
|
Centrifugation - Duration
COMPLETED
|
5
|
|
Centrifugation - Duration
NOT COMPLETED
|
0
|
|
Centrifugation - Schedule
STARTED
|
5
|
|
Centrifugation - Schedule
COMPLETED
|
5
|
|
Centrifugation - Schedule
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Centrifugation
Each subject will complete training at 3.5 cm off-axis. Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis. Subjects will have a wash out period of at least 2 weeks in between chair training distance (3.5 cm or 7.0 cm) until static SVV returns to normal. Then subjects will complete training at 7.0 cm off-axis. Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis.
Participants will receive 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo will be assessed at the start and end of each session.
|
|---|---|
|
Centrifugation - Distance
Lost to Follow-up
|
1
|
Baseline Characteristics
Vestibular Rehabilitation and Otolith Dysfunction
Baseline characteristics by cohort
| Measure |
Centrifugation Distance
n=6 Participants
Each subject will complete training at both chair positions (3.5 cm off-axis and 7.0 cm off-axis). Subjects will be randomized to start with either chair position (3.5 cm or 7.0 cm) and have a wash out period of at least 2 weeks in between chair training distance (3.5 cm or 7.0 cm) until static SVV returns to normal.
Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm or 7.0 cm off-axis and the other ear positioned on-axis. Participants will receive 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo will be assessed at the start and end of each session.
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|---|---|
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Age, Continuous
|
29.7 years
STANDARD_DEVIATION 3.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 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
|
0 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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
|
static subjective visual vertical
|
1.32 degrees
STANDARD_DEVIATION 0.71 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, immediately after 5 sessions of OAR training (1 week)Population: The progression through the study is sequential with participants first being tested at 3.5 cm and then at 7.0 cm (both for 1 minute duration) after a two-week washout period. Six participants initiated study testing at 3.5 cm for 1- minute duration, but one participant did not continue with the study. Thus, that participants data are available for the dataset at Distance = 3.5 cm and Duration = 1 minute.
Static subjective visual vertical (SVV) assesses spatial perception and is influenced by otolith function. Perception of vertical is measured in a darkened room with subject seated upright. The test assesses an individual's ability to adjust a laser line to be parallel with true vertical in the absence of any other visual cues. The start position of line for SVV testing is randomized and participants are instructed to use the track ball to position the line in a vertical position. Five trials are completed, and the software calculates the distance (in degrees) from vertical. The average of the trials is calculated and used for data analysis.
Outcome measures
| Measure |
Centrifugation Distance - 3.5 cm
n=6 Participants
Each subject completed training at chair position of 3.5 cm off-axis.
Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session.
|
Centrifugation Distance - 7.0 cm
n=5 Participants
Each subject completed training at chair position of 7.0 cm off-axis after completing training with chair position at 3.5 cm off-axis and having a wash out period of at least 2 weeks (or until static SVV returned to normal) prior to chair training at distance of 7.0 cm.
Participants were rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session.
|
Centrifugation Duration - 1 Minute
n=6 Participants
Each subject completed training at chair position of 3.5 cm off-axis.
Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute duration. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session.
|
Centrifugation Duration - 3 Minutes
n=5 Participants
After a wash out period of at least 2 weeks (or until static SVV returns to normal), each subject completed training at chair position of 3.5 cm off-axis.
Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes duration. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session.
|
Centrifugation Schedule - Daily
n=5 Participants
After a wash out period of at least 2 weeks (or until static SVV returned to normal), each subject completed training at chair position of 3.5 cm off-axis.
Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes. Participants received 5 consecutive sessions in a 1-week period (Monday-Friday). Static subjective visual vertigo was assessed at the start and end of each session.
|
Centrifugation Schedule - Biweekly
n=5 Participants
After a wash out period of at least 2 weeks (or until static SVV returned to normal), each subject completed training at chair position of 3.5 cm off-axis.
Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes. Participants received biweekly sessions for a total of 5 sessions. Static subjective visual vertigo was assessed at the start and end of each session.
|
|---|---|---|---|---|---|---|
|
Change in Static Subjective Visual Vertical (SVV)
|
0.69 degrees
Standard Deviation 0.51
|
0.58 degrees
Standard Deviation 1.47
|
0.69 degrees
Standard Deviation 0.51
|
0.89 degrees
Standard Deviation 1.14
|
0.89 degrees
Standard Deviation 1.14
|
0.32 degrees
Standard Deviation 1.22
|
Adverse Events
Centrifugation Distance - 3.5
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Centrifugation Distance - 7.0
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Centrifugation Duration - 3 Minutes
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Centrifugation Schedule - Biweekly
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Centrifugation Distance - 3.5
n=6 participants at risk
Participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 1 daily session for 5 consecutive days.
|
Centrifugation Distance - 7.0
n=5 participants at risk
Following a washout period of 2 weeks (or until SVV returned to baseline), participants were rotated in a darkened rotary chair booth with 1 ear positioned 7.0 cm off-axis and the other ear positioned on-axis for 1 minute. Participants received 1 daily session for 5 consecutive days.
|
Centrifugation Duration - 3 Minutes
n=5 participants at risk
Following a washout period of 2 weeks (or until SVV returned to baseline), participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes. Participants received 1 daily session for 5 consecutive days.
|
Centrifugation Schedule - Biweekly
n=5 participants at risk
Following a washout period of 2 weeks (or until SVV returned to baseline), participants were rotated in a darkened rotary chair booth with 1 ear positioned 3.5 cm off-axis and the other ear positioned on-axis for 3 minutes. Participants received biweekly sessions for a total of 5 sessions.
|
|---|---|---|---|---|
|
General disorders
Symptom of Nausea
|
16.7%
1/6 • Number of events 4 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
60.0%
3/5 • Number of events 4 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
60.0%
3/5 • Number of events 8 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
40.0%
2/5 • Number of events 4 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
|
General disorders
Symptom of Disorientation
|
100.0%
6/6 • Number of events 17 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
80.0%
4/5 • Number of events 16 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
80.0%
4/5 • Number of events 15 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
80.0%
4/5 • Number of events 10 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
|
General disorders
Symptom of Anxiety
|
16.7%
1/6 • Number of events 1 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
40.0%
2/5 • Number of events 2 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
60.0%
3/5 • Number of events 3 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
20.0%
1/5 • Number of events 1 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
|
General disorders
Symptom of Dizziness
|
66.7%
4/6 • Number of events 8 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
40.0%
2/5 • Number of events 5 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
60.0%
3/5 • Number of events 7 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
20.0%
1/5 • Number of events 1 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
|
General disorders
Symptom of Unsteadiness
|
66.7%
4/6 • Number of events 9 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
60.0%
3/5 • Number of events 10 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
40.0%
2/5 • Number of events 10 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
20.0%
1/5 • Number of events 5 • Assessment of symptoms was performed immediately following completion of each session of off-axis rotation for a total of 5 sessions within a centrifugation parameter, approximately 3 months.
To assess adverse events following off-axis rotation, participants completed visual analog scales to quantify severity of symptoms (nausea, disorientation, anxiety, imbalance, dizziness).
|
Additional Information
Research Health Science Specialist
James H Quillen VAMC
Phone: (423) 926-1171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place