NCT05511753

Brief Summary

In an era of advanced industry and commerce, working in a noisy environment is one of the most important risk factors for hearing damage, especially among young and middle-aged people. Although acupuncture has been widely used to treat otology-related diseases, such as tinnitus, dizziness, and sudden deafness, there are few studies on the effect of noise-induced hearing loss.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

August 16, 2022

Last Update Submit

August 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • pure tone audiometry observe changes in hearing

    The pure tone test measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.

    Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment

Study Arms (1)

pure tone audiometry improving

EXPERIMENTAL

Pure tone audiometry: observe changes in hearing ability Evaluation time: Before acupuncture treatment, 2 weeks, 4 weeks, 6 weeks after treatment, and 2 weeks after acupuncture treatment, pure-tone audiometry was performed. The pure tone audiometry measures the hearing thresholds of 2KHz, 4KHz and 8KHz respectively.

Device: electroacupuncture

Interventions

Insert stainless steel needles into the above acupoints and twist the needles to get qi. In addition, electroacupuncture stimulation (intensity 1mA, frequency 2Hz) was applied to connect the ipsilateral Yifeng and Wangu, and the ipsilateral Zhongzhu and Quchi.

pure tone audiometry improving

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pure tone audiometry diagnosed noise-induced hearing loss
  • age: 20 - 65

You may not qualify if:

  • major medical disease -- cancer, renal disease
  • pregnancy or milk women
  • anti-coagulation use
  • pacemaker use
  • allergy to needle
  • denied accept inform consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss, Noise-Induced

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Hearing Loss, SensorineuralHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 23, 2022

Study Start

September 1, 2022

Primary Completion

July 30, 2023

Study Completion

September 1, 2023

Last Updated

August 23, 2022

Record last verified: 2022-08