TinnitusNCT07711639
FR-taVNS Tinnitus Tria
A study testing True Foot Reflexology, True ta-VNS and True Auricular Acupressure in people with Tinnitus, run by Tzu Chi University at 1 site in Taiwan.
Trial summary
Tinnitus is a common neurosensory symptom affecting 12-30% of adults and is closely associated with anxiety, sleep disturbance, and autonomic dysregulation. Current pharmacologic treatments offer limited efficacy and notable side effects, prompting interest in non-pharmacological approaches. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- True Foot Reflexology, True ta-VNS and True Auricular Acupressure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, conscious, able to communicate and comprehend, and able to complete questionnaires and comply with study procedures
- Tinnitus as the sole chief complaint, with pure-tone thresholds ≤25 dB HL bilaterally at 500, 1000, 2000, and 4000 Hz
Who cannot join
- Objective tinnitus, peripheral vestibular disease, central nervous or cardiovascular causes, or other organic ear pathology
- Open wounds or skin lesions of the foot or ear, lower-limb edema, history of deep vein thrombosis, or diabetes with most recent HbA1c >7.5%
- Cardiac pacemaker or other implanted electronic device, or other severe cardiovascular disease
- Foot reflexology or vagus nerve stimulation within the past 3 months
- Pregnant or breastfeeding women
- History of epilepsy or seizures
- Physically frail condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chun-Hou Huang contact
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital, Department of Otorhinolaryngology
Hualien City, 970
Yu-Fu Chou Chou, MD, 886-3-8561825, hou2017@gms.tcu.edu.tw
About this study
Official title: Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Tinnitus in Non-Cancer Adult Populations
Tinnitus is a common neurosensory symptom affecting 12-30% of adults and is closely associated with anxiety, sleep disturbance, and autonomic dysregulation. Current pharmacologic treatments offer limited efficacy and notable side effects, prompting interest in non-pharmacological approaches. This randomized, single-blind, sham-controlled trial evaluates whether foot reflexology (FR), transcutaneous auricular vagus nerve stimulation (ta-VNS), and auricular acupressure (AA) improve tinnitus severity, psychological distress, sleep quality, and autonomic indicators (heart rate variability and salivary cortisol) in non-cancer adults with tinnitus, compared with usual care. Participants are randomized to a foot reflexology group, an auricular vagus nerve stimulation group (each with true and sham subgroups), or a usual-care control group, and are followed at baseline and weeks 2, 4, and 8.
Read the detailed description
This is a three-arm parallel, repeated-measures randomized controlled trial conducted in the otolaryngology outpatient and inpatient settings of Hualien Tzu Chi Hospital. Eligible non-cancer adults with tinnitus as the sole chief complaint and normal pure-tone thresholds are stratified by age and sex, then randomized by computer-generated random number tables to the FR group, the ta-VNS group, or the usual-care control group; the FR and ta-VNS groups are further randomized to true or sham subgroups. The foot reflexology intervention is delivered once weekly for 20 minutes over four sessions (one month) and comprises a relaxation phase, an inner-ear/autonomic regulation phase, and a circulation/detoxification phase; the sham condition applies light, non-specific touch. The ta-VNS intervention stimulates the left tragus, cymba conchae, and cavum conchae (pulse width 250 µs, 25 Hz, 0.5-5 mA individualized to a tingling sensation, 30 s on/off) once weekly for 20 minutes over four weeks; the sham condition stimulates the left earlobe at 0.5 mA. Auricular acupressure with magnetic beads is self-administered three times daily. Outcomes are assessed at T0 (baseline), T1 (week 2), T2 (week 4), and T3 (week 8). Data are analyzed with generalized estimating equation (GEE) models.
- Conditions
- Tinnitus
- Being tested
- True Foot Reflexology, Sham Foot Reflexology, True ta-VNS, Sham ta-VNS, True Auricular Acupressure
- Keywords
- Foot Reflexology, Transcutaneous Auricular Vagus Nerve Stimulation, ta-VNS, Auricular Acupressure, Tinnitus, Heart Rate Variability, Salivary Cortisol, Sleep Quality, Non-pharmacological intervention
- Medical subject headings
- Tinnitus, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
True Foot ReflexologyProcedure or surgery
Once weekly, 20 min, 4 sessions over 1 month. Three phases: relaxation (diaphragm, brain, spine reflex zones, 3 min); inner-ear and autonomic regulation (inner ear, hypothalamus, cerebellum, brainstem, thyroid, adrenal zones, 10 min); circulation/detoxification (kidney, lymphatic zones, 7 min).
Sham Foot ReflexologyProcedure or surgery
Light touch on non-specific foot areas (dorsum, anterior ankle, foot margins) without effective pressure.
True ta-VNSDevice
Left tragus, cymba conchae, cavum conchae; 250 µs, 25 Hz, 0.5-5 mA individualized to tingling, 30 s on/off; once weekly, 20 min, 4 weeks. Device: Hong-Tai mid-frequency electrotherapy stimulator, model HT66B (TFDA license no. 000637), used off-label for auricular vagus nerve stimulation.
Sham ta-VNSDevice
Left earlobe, 0.5 mA, otherwise identical parameters (250 µs, 25 Hz, 30 s on/off).
True Auricular AcupressureProcedure or surgery
Magnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; pressed 3×/day, ~30 s per point; changed every 2-3 days.
Sham Auricular AcupressureProcedure or surgery
Beads at left earlobe (non-vagal regions), same frequency/duration.
Usual CareOther
Standard tinnitus clinical care (pharmacologic and supportive); no study intervention.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Foot Reflexology - True (n=36) | Experimental | Procedure: True Foot Reflexology Receives: Procedure: True Foot Reflexology |
| Arm B: Foot Reflexology - Sham (n=36) | Sham comparator | Procedure: Sham Foot Reflexology Receives: Procedure: Sham Foot Reflexology |
| Arm C: ta-VNS - True (n=36) | Experimental | Device: True ta-VNS + Procedure: Auricular Acupressure Receives: Device: True ta-VNS; Procedure: True Auricular Acupressure |
| Arm D: ta-VNS - Sham (n=36) | Sham comparator | Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure Receives: Device: Sham ta-VNS; Procedure: Sham Auricular Acupressure |
| Arm E: Usual Care (n=36) | Active comparator | Other: Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tinnitus Handicap Inventory (THI) score
25-item scale across functional, emotional, and catastrophic subscales; total 0-100, higher = greater handicap.
Measured: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Tinnitus Functional Index (TFI) score
25-item scale; total 0-100, higher = greater impact.
Measured: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Secondary outcomes (4)
Change in Distress Thermometer (DT)
0-10 single-item rating; >=4 indicates clinically significant distress.
Measured: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Pittsburgh Sleep Quality Index (PSQI)
19-item; total 0-21, >5 indicates poor sleep.
Measured: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Heart Rate Variability (HRV)
TS-0411 wrist device (HRV Master, TFDA license no. 001525), after 10-min rest, ~5-min wrist recording.
Measured: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in salivary cortisol concentration
1 cc saliva, ELISA.
Measured: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start28 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tzu Chi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Hou Huang, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711639
- Sponsor's protocol ID
- Tzu Chi University
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stegeman I, Velde HM, Robe PAJT, Stokroos RJ, Smit AL. Tinnitus treatment by vagus nerve stimulation: A systematic review. PLoS One. 2021 Mar 11;16(3):e0247221. doi: 10.1371/journal.pone.0247221. eCollection 2021.
PubMed 33705401Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.
PubMed 8630207
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Foot Reflexology and Transcutaneous Auricular Vagus Nerve Stimulation on Tinnitus in Non-Cancer Adult Populations
- ClinicalTrials.gov ID
- NCT07711639
- Acronym / sponsor ID
- Tzu Chi University
- Conditions
- Tinnitus
- Keywords
- Foot Reflexology, Transcutaneous Auricular Vagus Nerve Stimulation, ta-VNS, Auricular Acupressure, Tinnitus, Heart Rate Variability, Salivary Cortisol, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tzu Chi UniversityUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tinnitus is a common neurosensory symptom affecting 12-30% of adults and is closely associated with anxiety, sleep disturbance, and autonomic dysregulation. Current pharmacologic treatments offer limited efficacy and notable side effects, prompting interest in non-pharmacological approaches. This randomized, single-blind, sham-controlled trial evaluates whether foot reflexology (FR), transcutaneous auricular vagus nerve stimulation (ta-VNS), and auricular acupressure (AA) improve tinnitus severity, psychological distress, sleep quality, and autonomic indicators (heart rate variability and salivary cortisol) in non-cancer adults with tinnitus, compared with usual care. Participants are randomized to a foot reflexology group, an auricular vagus nerve stimulation group (each with true and sham subgroups), or a usual-care control group, and are followed at baseline and weeks 2, 4, and 8.
Detailed description
This is a three-arm parallel, repeated-measures randomized controlled trial conducted in the otolaryngology outpatient and inpatient settings of Hualien Tzu Chi Hospital. Eligible non-cancer adults with tinnitus as the sole chief complaint and normal pure-tone thresholds are stratified by age and sex, then randomized by computer-generated random number tables to the FR group, the ta-VNS group, or the usual-care control group; the FR and ta-VNS groups are further randomized to true or sham subgroups. The foot reflexology intervention is delivered once weekly for 20 minutes over four sessions (one month) and comprises a relaxation phase, an inner-ear/autonomic regulation phase, and a circulation/detoxification phase; the sham condition applies light, non-specific touch. The ta-VNS intervention stimulates the left tragus, cymba conchae, and cavum conchae (pulse width 250 µs, 25 Hz, 0.5-5 mA individualized to a tingling sensation, 30 s on/off) once weekly for 20 minutes over four weeks; the sham condition stimulates the left earlobe at 0.5 mA. Auricular acupressure with magnetic beads is self-administered three times daily. Outcomes are assessed at T0 (baseline), T1 (week 2), T2 (week 4), and T3 (week 8). Data are analyzed with generalized estimating equation (GEE) models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm A: Foot Reflexology - True (n=36) | Experimental | Procedure: True Foot ReflexologyProcedure: True Foot Reflexology |
| Arm B: Foot Reflexology - Sham (n=36) | Sham comparator | Procedure: Sham Foot ReflexologyProcedure: Sham Foot Reflexology |
| Arm C: ta-VNS - True (n=36) | Experimental | Device: True ta-VNS, Procedure: True Auricular AcupressureDevice: True ta-VNS + Procedure: Auricular Acupressure |
| Arm D: ta-VNS - Sham (n=36) | Sham comparator | Device: Sham ta-VNS, Procedure: Sham Auricular AcupressureDevice: Sham ta-VNS + Procedure: Sham Auricular Acupressure |
| Arm E: Usual Care (n=36) | Active comparator | Other: Usual CareOther: Usual Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-75 years, conscious, able to communicate and comprehend, and able to complete questionnaires and comply with study procedures
- Tinnitus as the sole chief complaint, with pure-tone thresholds ≤25 dB HL bilaterally at 500, 1000, 2000, and 4000 Hz
Key exclusion criteria (7 listed)
- Objective tinnitus, peripheral vestibular disease, central nervous or cardiovascular causes, or other organic ear pathology
- Open wounds or skin lesions of the foot or ear, lower-limb edema, history of deep vein thrombosis, or diabetes with most recent HbA1c >7.5%
- Cardiac pacemaker or other implanted electronic device, or other severe cardiovascular disease
- Foot reflexology or vagus nerve stimulation within the past 3 months
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| True Foot ReflexologyOnce weekly, 20 min, 4 sessions over 1 month. Three phases: relaxation (diaphragm, brain, spine reflex zones, 3 min); inner-ear and autonomic regulation (inner ear, hypothalamus, cerebellum, brainstem, thyroid, adrenal zones, 10 min); circulation/detoxification (kidney, lymphatic zones, 7 min). | Procedure or surgery | Arm A: Foot Reflexology - True (n=36) |
| Sham Foot ReflexologyLight touch on non-specific foot areas (dorsum, anterior ankle, foot margins) without effective pressure. | Procedure or surgery | Arm B: Foot Reflexology - Sham (n=36) |
| True ta-VNSLeft tragus, cymba conchae, cavum conchae; 250 µs, 25 Hz, 0.5-5 mA individualized to tingling, 30 s on/off; once weekly, 20 min, 4 weeks. Device: Hong-Tai mid-frequency electrotherapy stimulator, model HT66B (TFDA license no. 000637), used off-label for auricular vagus nerve stimulation. | Device | Arm C: ta-VNS - True (n=36) |
| Sham ta-VNSLeft earlobe, 0.5 mA, otherwise identical parameters (250 µs, 25 Hz, 30 s on/off). | Device | Arm D: ta-VNS - Sham (n=36) |
| True Auricular AcupressureMagnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; pressed 3×/day, ~30 s per point; changed every 2-3 days. | Procedure or surgery | Arm C: ta-VNS - True (n=36) |
| Sham Auricular AcupressureBeads at left earlobe (non-vagal regions), same frequency/duration. | Procedure or surgery | Arm D: ta-VNS - Sham (n=36) |
| Usual CareStandard tinnitus clinical care (pharmacologic and supportive); no study intervention. | Other | Arm E: Usual Care (n=36) |
Primary outcome
Change in Tinnitus Handicap Inventory (THI) score
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
25-item scale across functional, emotional, and catastrophic subscales; total 0-100, higher = greater handicap.
Change in Tinnitus Functional Index (TFI) score
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
25-item scale; total 0-100, higher = greater impact.
4 secondary outcomes
Change in Distress Thermometer (DT)
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in Heart Rate Variability (HRV)
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Change in salivary cortisol concentration
Time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Results publication: PubMed 33705401Stegeman I, Velde HM, Robe PAJT, Stokroos RJ, Smit AL. Tinnitus treatment by vagus nerve stimulation: A systematic review. PLoS One. 2021 Mar 11;16(3):e0247221. doi: 10.1371/journal.pone.0247221. eCollection 2021.
- Results publication: PubMed 8630207Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chun-Hou Huang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing True Foot Reflexology, True ta-VNS and True Auricular Acupressure in people with Tinnitus, run by Tzu Chi University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Fu Chou MD (886-3-8561825, yufuchou@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tinnitus Handicap Inventory (THI) score (time frame: T0 baseline, T1 week 2, T2 week 4, T3 week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07711639, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.