NCT07711639

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Dec 2028

Study Start

First participant enrolled

April 28, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

2.7 years

First QC Date

July 13, 2026

Last Update Submit

July 23, 2026

Conditions

Tinnitus

Keywords

Foot ReflexologyTranscutaneous Auricular Vagus Nerve Stimulationta-VNSAuricular AcupressureTinnitusHeart Rate VariabilitySalivary CortisolSleep QualityNon-pharmacological intervention

Outcome Measures

Primary Outcomes (2)

  • Change in Tinnitus Handicap Inventory (THI) score

    25-item scale across functional, emotional, and catastrophic subscales; total 0-100, higher = greater handicap.

    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.

    T0 baseline, T1 week 2, T2 week 4, T3 week 8

Secondary Outcomes (4)

  • Change in Distress Thermometer (DT)

    T0 baseline, T1 week 2, T2 week 4, T3 week 8

  • Change in Pittsburgh Sleep Quality Index (PSQI)

    T0 baseline, T1 week 2, T2 week 4, T3 week 8

  • Change in Heart Rate Variability (HRV)

    T0 baseline, T1 week 2, T2 week 4, T3 week 8

  • Change in salivary cortisol concentration

    T0 baseline, T1 week 2, T2 week 4, T3 week 8

Study Arms (5)

Arm A: Foot Reflexology - True (n=36)

EXPERIMENTAL

Procedure: True Foot Reflexology

Procedure: True Foot Reflexology

Arm B: Foot Reflexology - Sham (n=36)

SHAM COMPARATOR

Procedure: Sham Foot Reflexology

Procedure: Sham Foot Reflexology

Arm C: ta-VNS - True (n=36)

EXPERIMENTAL

Device: True ta-VNS + Procedure: Auricular Acupressure

Device: True ta-VNSProcedure: True Auricular Acupressure

Arm D: ta-VNS - Sham (n=36)

SHAM COMPARATOR

Device: Sham ta-VNS + Procedure: Sham Auricular Acupressure

Device: Sham ta-VNSProcedure: Sham Auricular Acupressure

Arm E: Usual Care (n=36)

ACTIVE COMPARATOR

Other: Usual Care

Other: Usual Care

Interventions

True Auricular AcupressurePROCEDURE

Magnetic beads (1-2 mm) at left tragus, cymba conchae, cavum conchae; pressed 3×/day, \~30 s per point; changed every 2-3 days.

Arm C: ta-VNS - True (n=36)
Usual CareOTHER

Standard tinnitus clinical care (pharmacologic and supportive); no study intervention.

Arm E: Usual Care (n=36)
True Foot ReflexologyPROCEDURE

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).

Arm A: Foot Reflexology - True (n=36)
Sham Foot ReflexologyPROCEDURE

Light touch on non-specific foot areas (dorsum, anterior ankle, foot margins) without effective pressure.

Arm B: Foot Reflexology - Sham (n=36)
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.

Arm C: ta-VNS - True (n=36)
Sham ta-VNSDEVICE

Left earlobe, 0.5 mA, otherwise identical parameters (250 µs, 25 Hz, 30 s on/off).

Arm D: ta-VNS - Sham (n=36)
Sham Auricular AcupressurePROCEDURE

Beads at left earlobe (non-vagal regions), same frequency/duration.

Arm D: ta-VNS - Sham (n=36)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hualien Tzu Chi Hospital, Department of Otorhinolaryngology

Hualien City, 970, Taiwan

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33705401RESULT

  • Newman 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.

    PMID: 8630207RESULT

MeSH Terms

Conditions

TinnitusSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Central Study Contacts

Yu-Fu Chou MD

CONTACT

886-3-8561825yufuchou@yahoo.com.tw

Chun-Hou Huang

CONTACT

hou2017@gms.tcu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 17, 2026

Study Start

April 28, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)