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TinnitusNCT05829278

Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS

A study testing Acupuncture in people with Tinnitus, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized controlled pilot trial aims to explore the Efficacy and central mechanism of acupuncture for treating chronic subjective tinnitus using functional near-infrared spectroscopy (fNIRS). Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Tinnitus
What is being tested?
Acupuncture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
May 2023to Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Bilateral tinnitus that meets the diagnostic criteria for chronic subjective tinnitus.
  • Male and female, Aged between 18 and 60 years.
  • Participants can cooperate with experimental procedures and sign written inform consent.
  • Not participating in other clinical trials concurrently.

Who cannot join

  • Participants with objective tinnitus
  • Participants have nervous system diseases or neuropsychiatric diseases that can significantly affect brain blood oxygen metabolism assessed by resting-state functional connectivity.
  • Participants with severe cardiovascular and cerebrovascular diseases, malignant liver and kidney diseases, and other serious diseases.
  • Participants have any contraindications for acupuncture (such as a bleeding tendency)
  • Pregnant or lactating women.
  • Participants have received tinnitus treatment with drugs or other therapies in the last four weeks.

Trial locations and contacts

1 site in 1 country.

Xiaoqi Lin, M.M contact

15017541801 ext. 86

linxq361@163.com

China1 site

  • the Third Affiliated Hospital of Zhejiang Chinese Medical University

    Hangzhou, Zhejiang, 310000

    Hantong Hu, MD, 18667103032 ext. 86, 413351308@qq.com

    Xiaoqi Lin, Ph.D, 15017541803 ext. 86, linxq361@163.com

Other trials in China

About this study

Official title: Efficacy and Central Mechanism of Acupuncture for Treating Chronic Subjective Tinnitus Assessed by fNIRS: Study Protocol for a Randomized Controlled Pilot Trial

This randomized controlled pilot trial aims to explore the Efficacy and central mechanism of acupuncture for treating chronic subjective tinnitus using functional near-infrared spectroscopy (fNIRS).

Read the detailed description

A total of 60 tinnitus patients were randomly assigned to either an acupuncture group or a waiting list group in a 1:1 ratio. Subjects in the acupuncture group will undergo 4-week acupuncture treatment, while subjects in the waiting list group will receive no treatment during the 4 weeks.

Conditions
Tinnitus
Being tested
Acupuncture
Keywords
acupuncture, moxibustion, tinnitus, randomized controlled trial
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureProcedure or surgery

    Acupuncture will be performed at acupoints including TE17 (Yifeng), SI19 (Tinggong), GB2 (Tinghui), TE5 (Waiguan), TE3 (Zhongzhu), ST36(Zusanli ), KI3 (Taixi), and etc.

Study groups in NCT05829278
Study groupRoleWhat they receive
Acupuncture groupExperimentalSubjects in the acupuncture group will undergo acupuncture treatment, which is administered 3 times a week for 4 weeks.
Receives: Procedure: Acupuncture
Waiting list groupNo interventionNo intervention will be provided for the waiting list group and the subjects in this group will be followed during the 4-week observation period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in resting-state functional connectivity (RSFC)

    RSFC will be measured by functional near-infrared spectroscopy (fNIRS).

    Measured: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

  2. Change in hemoglobin signals

    Hemoglobin signals will be measured by functional near-infrared spectroscopy (fNIRS).

    Measured: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

Secondary outcomes (4)

  1. Change in Tinnitus Handicap Inventory score

    Tinnitus Handicap Inventory contains 25 items, each valued at 0-4 points. A larger score indicates a more severe degree of tinnitus.

    Measured: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

  2. Change in average pure-tone threshold

    Average pure-tone threshold will be assessed by pure-tone audiometry.

    Measured: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

  3. Change in Hamilton Anxiety Scale score

    Hamilton Anxiety Scale is a reliable indicator of the severity of anxiety symptoms. The Hamilton Anxiety Scale consists of 14 items, each rated on a 5-point scale from 0 to 4. A larger score indicates a more severe degree of anxiety.

    Measured: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

  4. Change in tinnitus loudness

    Tinnitus loudness will be measure by using an 11-point numerical rating scale, with 0 indicating no tinnitus and 10 indicating maximum intolerable tinnitus.

    Measured: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study startMay 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05829278
Sponsor's protocol ID
YLKY-2021-01-01
Status last verified
Apr 2023
First submitted
11 Apr 2023
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kuzucu I, Karaca O. Acupuncture Treatment in Patients with Chronic Subjective Tinnitus: A Prospective, Randomized Study. Med Acupunct. 2020 Feb 1;32(1):24-28. doi: 10.1089/acu.2019.1367. Epub 2020 Feb 3.

    PubMed 32104524

  • Hu H, Lin X, Fang L, Li Y, Gao H. Evaluating the Efficacy and Underlying Mechanisms of Acupuncture for Chronic Subjective Tinnitus Using Functional Near-Infrared Spectroscopy: Study Protocol for a Randomized Controlled Trial. J Pain Res. 2023 Oct 4;16:3367-3378. doi: 10.2147/JPR.S433048. eCollection 2023.

    PubMed 37814607

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Tinnitus, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.

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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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 China. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaoqi Lin, M.M (15017541801 ext. 86, linxq361@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in resting-state functional connectivity (RSFC) (time frame: at baseline (pre-treatment), at 4 weeks after intervention, at 3-month follow-up). 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 NCT05829278, 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 25 Apr 2023.

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