Trial Outcomes & Findings for Sensory Integration of Auditory and Visual Cues in Diverse Contexts (NCT NCT04479761)
NCT ID: NCT04479761
Last Updated: 2025-02-05
Results Overview
RMSV is defined the difference in position between two data points divided by the average time interval, with the velocities at each point squared then summed. The square root of this sum is then divided by the number of data points. Higher values reflect more postural sway. This will be calculated as an average across repetitions where participants saw a moving subway environment (dynamic visuals) combined with real-recorded sounds (moving sounds). Higher RMSV indicated less postural stability. This metric is calculated from center-of-pressure data collected by a force platform. Participants were standing on foam placed on the force platform.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
Will be measured during all 60 seconds scenes
Results posted on
2025-02-05
Participant Flow
Participant milestones
| Measure |
Vestibular Hypofunction
Participants with unilateral peripheral vestibular hypofunction and normal hearing were recruited from vestibular rehabilitation at the New York Eye and Ear Infirmary of Mount Sinai. Potentially eligible participants with a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life were identified during their standard clinical evaluation. Participants presented with at least 1 positive finding indicating unilateral vestibular hypofunction on the following clinical tests: head thrust, subjective visual vertical and horizontal, post head shaking nystagmus, spontaneous and gaze holding nystagmus, in addition to a score of at least 16 (mild handicap) on the Dizziness Handicap Inventory (DHI).
|
Unilateral Hearing Loss (UHL)
Participants with a stable UHL, no evidence of retrocochlear pathology on MRI and no active complaint of dizziness (Dizziness Handicap Inventory \[DHI\] score \<16) were recruited from a single tertiary, urban otology practice or from clinicaltrials.org. UHL was defined as having an unaided pure-tone average (PTA) of hearing thresholds at 0.5, 1, 2, and 4 kHz in the affected ear ≥ 40 dB HL and normal hearing in the contralateral ear.
|
Healthy Controls
Healthy controls with normal hearing, no vestibular complaints, no history of vestibular or other issues that may influence balance, were recruited from the university community and via clinicaltrials.org
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
35
|
42
|
|
Overall Study
COMPLETED
|
28
|
32
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
Vestibular Hypofunction
Participants with unilateral peripheral vestibular hypofunction and normal hearing were recruited from vestibular rehabilitation at the New York Eye and Ear Infirmary of Mount Sinai. Potentially eligible participants with a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life were identified during their standard clinical evaluation. Participants presented with at least 1 positive finding indicating unilateral vestibular hypofunction on the following clinical tests: head thrust, subjective visual vertical and horizontal, post head shaking nystagmus, spontaneous and gaze holding nystagmus, in addition to a score of at least 16 (mild handicap) on the Dizziness Handicap Inventory (DHI).
|
Unilateral Hearing Loss (UHL)
Participants with a stable UHL, no evidence of retrocochlear pathology on MRI and no active complaint of dizziness (Dizziness Handicap Inventory \[DHI\] score \<16) were recruited from a single tertiary, urban otology practice or from clinicaltrials.org. UHL was defined as having an unaided pure-tone average (PTA) of hearing thresholds at 0.5, 1, 2, and 4 kHz in the affected ear ≥ 40 dB HL and normal hearing in the contralateral ear.
|
Healthy Controls
Healthy controls with normal hearing, no vestibular complaints, no history of vestibular or other issues that may influence balance, were recruited from the university community and via clinicaltrials.org
|
|---|---|---|---|
|
Overall Study
could not perform the balance tasks
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
one control did not meet screening criteria
|
0
|
0
|
1
|
|
Overall Study
hearing loss recovered OR hearing loss too severe on the other side OR dizziness above 16 on DHI
|
0
|
3
|
0
|
Baseline Characteristics
Sensory Integration of Auditory and Visual Cues in Diverse Contexts
Baseline characteristics by cohort
| Measure |
Vestibular Hypofunction
n=30 Participants
Participants with unilateral peripheral vestibular hypofunction and normal hearing were recruited from vestibular rehabilitation at the New York Eye and Ear Infirmary of Mount Sinai. Potentially eligible participants with a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life were identified during their standard clinical evaluation. Participants presented with at least 1 positive finding indicating unilateral vestibular hypofunction on the following clinical tests: head thrust, subjective visual vertical and horizontal, post head shaking nystagmus, spontaneous and gaze holding nystagmus, in addition to a score of at least 16 (mild handicap) on the Dizziness Handicap Inventory (DHI).
|
Unilateral Hearing Loss (UHL)
n=35 Participants
Participants with a stable UHL, no evidence of retrocochlear pathology on MRI and no active complaint of dizziness (Dizziness Handicap Inventory \[DHI\] score \<16) were recruited from a single tertiary, urban otology practice or from clinicaltrials.org. UHL was defined as having an unaided pure-tone average (PTA) of hearing thresholds at 0.5, 1, 2, and 4 kHz in the affected ear ≥ 40 dB HL and normal hearing in the contralateral ear.
|
Healthy Controls
n=42 Participants
Healthy controls with normal hearing, no vestibular complaints, no history of vestibular or other issues that may influence balance, were recruited from the university community and via clinicaltrials.org
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.6 years
n=5 Participants
|
52.2 years
n=7 Participants
|
52 years
n=5 Participants
|
54.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 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
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Will be measured during all 60 seconds scenesRMSV is defined the difference in position between two data points divided by the average time interval, with the velocities at each point squared then summed. The square root of this sum is then divided by the number of data points. Higher values reflect more postural sway. This will be calculated as an average across repetitions where participants saw a moving subway environment (dynamic visuals) combined with real-recorded sounds (moving sounds). Higher RMSV indicated less postural stability. This metric is calculated from center-of-pressure data collected by a force platform. Participants were standing on foam placed on the force platform.
Outcome measures
| Measure |
Vestibular Hypofunction
n=28 Participants
Participants with unilateral peripheral vestibular hypofunction and normal hearing were recruited from vestibular rehabilitation at the New York Eye and Ear Infirmary of Mount Sinai. Potentially eligible participants with a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life were identified during their standard clinical evaluation. Participants presented with at least 1 positive finding indicating unilateral vestibular hypofunction on the following clinical tests: head thrust, subjective visual vertical and horizontal, post head shaking nystagmus, spontaneous and gaze holding nystagmus, in addition to a score of at least 16 (mild handicap) on the Dizziness Handicap Inventory (DHI).
|
Unilateral Hearing Loss (UHL)
n=32 Participants
Participants with a stable UHL, no evidence of retrocochlear pathology on MRI and no active complaint of dizziness (Dizziness Handicap Inventory \[DHI\] score \<16) were recruited from a single tertiary, urban otology practice or from clinicaltrials.org. UHL was defined as having an unaided pure-tone average (PTA) of hearing thresholds at 0.5, 1, 2, and 4 kHz in the affected ear ≥ 40 dB HL and normal hearing in the contralateral ear.
|
Healthy Controls
n=41 Participants
Healthy controls with normal hearing, no vestibular complaints, no history of vestibular or other issues that may influence balance, were recruited from the university community and via clinicaltrials.org
|
|---|---|---|---|
|
Root Mean Square Velocity Anterior-posterior [AP] in cm/s (RMSV)
|
3.59 cm/s
Interval 3.24 to 3.98
|
3.30 cm/s
Interval 3.01 to 3.63
|
3.07 cm/s
Interval 2.83 to 3.33
|
SECONDARY outcome
Timeframe: measured during all 60 seconds scenesRMSV is defined the difference in position between two data points divided by the average time interval, with the velocities at each point squared then summed. The square root of this sum is then divided by the number of data points. Higher values reflect more postural sway. This will be calculated as an average across repetitions where participants saw a moving subway environment (dynamic visuals) combined with real-recorded sounds (moving sounds). Higher RMSV indicated less postural stability. This metric is calculated from center-of-pressure data collected by a force platform. Participants were standing on foam placed on the force platform.
Outcome measures
| Measure |
Vestibular Hypofunction
n=28 Participants
Participants with unilateral peripheral vestibular hypofunction and normal hearing were recruited from vestibular rehabilitation at the New York Eye and Ear Infirmary of Mount Sinai. Potentially eligible participants with a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life were identified during their standard clinical evaluation. Participants presented with at least 1 positive finding indicating unilateral vestibular hypofunction on the following clinical tests: head thrust, subjective visual vertical and horizontal, post head shaking nystagmus, spontaneous and gaze holding nystagmus, in addition to a score of at least 16 (mild handicap) on the Dizziness Handicap Inventory (DHI).
|
Unilateral Hearing Loss (UHL)
n=32 Participants
Participants with a stable UHL, no evidence of retrocochlear pathology on MRI and no active complaint of dizziness (Dizziness Handicap Inventory \[DHI\] score \<16) were recruited from a single tertiary, urban otology practice or from clinicaltrials.org. UHL was defined as having an unaided pure-tone average (PTA) of hearing thresholds at 0.5, 1, 2, and 4 kHz in the affected ear ≥ 40 dB HL and normal hearing in the contralateral ear.
|
Healthy Controls
n=41 Participants
Healthy controls with normal hearing, no vestibular complaints, no history of vestibular or other issues that may influence balance, were recruited from the university community and via clinicaltrials.org
|
|---|---|---|---|
|
Root Mean Square Velocity in the Medio-lateral Direction in cm/s (RMSV)
|
1.66 cm/s
Interval 1.48 to 1.87
|
1.50 cm/s
Interval 1.35 to 1.66
|
1.43 cm/s
Interval 1.31 to 1.57
|
Adverse Events
Vestibular Hypofunction
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Unilateral Hearing Loss (UHL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vestibular Hypofunction
n=28 participants at risk
Participants with unilateral peripheral vestibular hypofunction and normal hearing were recruited from vestibular rehabilitation at the New York Eye and Ear Infirmary of Mount Sinai. Potentially eligible participants with a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life were identified during their standard clinical evaluation. Participants presented with at least 1 positive finding indicating unilateral vestibular hypofunction on the following clinical tests: head thrust, subjective visual vertical and horizontal, post head shaking nystagmus, spontaneous and gaze holding nystagmus, in addition to a score of at least 16 (mild handicap) on the Dizziness Handicap Inventory (DHI).
|
Unilateral Hearing Loss (UHL)
n=32 participants at risk
Participants with a stable UHL, no evidence of retrocochlear pathology on MRI and no active complaint of dizziness (Dizziness Handicap Inventory \[DHI\] score \<16) were recruited from a single tertiary, urban otology practice or from clinicaltrials.org. UHL was defined as having an unaided pure-tone average (PTA) of hearing thresholds at 0.5, 1, 2, and 4 kHz in the affected ear ≥ 40 dB HL and normal hearing in the contralateral ear.
|
Healthy Controls
n=41 participants at risk
Healthy controls with normal hearing, no vestibular complaints, no history of vestibular or other issues that may influence balance, were recruited from the university community and via clinicaltrials.org
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tinnitus
|
3.6%
1/28 • Number of events 1 • 2 weeks
|
0.00%
0/32 • 2 weeks
|
0.00%
0/41 • 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place