Trial Outcomes & Findings for Auditory-somatosensory Stimulation to Alleviate Tinnitus (NCT NCT02974543)

Last Updated: 2017-05-17

Results Overview

Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

Four weeks on treatment (or sham)

Results posted on

2017-05-17

Participant Flow

14 participants consented to the study, but were screened out of allocation to either arm for excess hearing loss, lack of somatosensory modulation, or unwillingness to participate (largely due to time committments/availability).

Participant milestones

Participant milestones
Measure	Sham 1st (Auditory Only) Then Active (Bimodal) To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. The auditory stimulus will be individualized based on s	Active (Bimodal) Then Sham (Auditory Only) During active treatment, the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. The auditory stimulus will be individualized based on s
Overall Study STARTED	11	10
Overall Study Began Washout Period	10	10
Overall Study Began Crossover Assignment	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham 1st (Auditory Only) Then Active (Bimodal) To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. The auditory stimulus will be individualized based on s	Active (Bimodal) Then Sham (Auditory Only) During active treatment, the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus. The auditory stimulus will be individualized based on s
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Auditory-somatosensory Stimulation to Alleviate Tinnitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active 1st (Bimodal) Then Sham (Auditory Only) n=10 Participants During active treatment the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.	Sham 1st (Auditory Only) Then Active (Bimodal) n=10 Participants To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Tinnitus Functional Index (TFI)	34.88 units on a scale STANDARD_DEVIATION 16.70 • n=5 Participants	26.66 units on a scale STANDARD_DEVIATION 14.78 • n=7 Participants	31.78 units on a scale STANDARD_DEVIATION 16.70 • n=5 Participants
Tinnitus Loudness	58.99 dB STANDARD_DEVIATION 14.77 • n=5 Participants	49.85 dB STANDARD_DEVIATION 18.25 • n=7 Participants	54.42 dB STANDARD_DEVIATION 14.77 • n=5 Participants

PRIMARY outcome

Timeframe: Four weeks on treatment (or sham)

Population: First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).

Outcome measures

Outcome measures
Measure	Active Before Sham n=10 Participants	Washout After Active n=10 Participants	Sham After Active n=10 Participants	Sham Before Active n=10 Participants	Washout After Sham n=10 Participants	Active After Sham n=10 Participants
Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline	-10.08 units on a scale Standard Deviation 6.79	-5.40 units on a scale Standard Deviation 4.11	0.95 units on a scale Standard Deviation 10.32	-4.34 units on a scale Standard Deviation 4.11	-2.24 units on a scale Standard Deviation 4.58	-5.27 units on a scale Standard Deviation 6.46

PRIMARY outcome

Timeframe: 4 weeks on treatment (or sham)

Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.