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Effects of Huperzine A on Presbycusis(Δ,kHz, dB,MMSE, AD)

Primary Purpose

Presbycusis, Tinnitus, Cognitive Impairment

Status

Enrolling by invitation

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

BTHE and Huperzine A

BETH

About this trial

This is an interventional treatment trial for Presbycusis focused on measuring presbycusis, tinnitus, cognitive impairment, Huperzine A, age-related hearing impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(1) 60 to 85 years old; (2) Mild-to-moderate sensorineural hearing loss (the pure tone averaged across octave frequencies between 0.25 to 4kHz of 26-70 dB HL), with subjective tinnitus, subjective cognitive decline or mild cognitive impairment; (3) Able to tolerate huperzine A treatment; (4) more than 3 months' experience of constant tinnitus; (5) Tinnitus Handicap Inventory score values >10; (6) No participation in any other clinical trial in the past 3 months; (7) Able to accomplish relevant tests and follow-up.

Exclusion Criteria:

(1) Conductive hearing loss; (2) current (3+ months) hearing aid(s) user; (3) Dependence due to poor physical activity; (4) Allergic to huperzine A; (5) History of malignancy within 5 years or other serious medical conditions before screening, including severe bradycardia, hypotension, angina, asthma, ileus, renal insufficiency, neurological diseases (e.g. epilepsy), psychiatric disorder (e.g. schizophrenia, severe depression and anxiety); (6) Acute brain trauma and stroke within 2 weeks; (7) history of general pain disorder and the use of pain relief drugs on a regular basis; (8) Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before investigation starts. (9) Individuals simultaneously or previously (within 30 days prior to investigation start) participate in a clinical investigation using experimental drugs or devices. (10) Ongoing serious life event; (11) Vision impairment.

Sites / Locations

Huadong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Huperzine A intervention

control

Arm Description

Huperzine A intervention: Huperzine A with a dose 0.1~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education

Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.

Outcomes

Primary Outcome Measures

hearing function protection

All participants (including with tinnitus and without tinnitus) will report in the measure. Δ value of averaged hearing threshold = re-test threshold - initial threshold, Δ value of averaged hearing threshold ≤ 0 showed good responders, and > 0 showed poor responders.

Secondary Outcome Measures

global cognitive function protection

All participants (including with tinnitus and without tinnitus) will report in the outcome measure. ΔMMSE = re-test MMSE - initial MMSE, ΔMMSE< 0 showed poor responders and hearing threshold ≤ 0 showed good responders; and > 0 showed poor responders ΔMMSE≥ 0 showed good responders

special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands

MMSE scale in different domains (MMSE SCALE, 0-30)

Tinnitus suppression

150 participants with tinnitus will report in the outcome measure. Method 1: tinnitus functional index (0~100，≤25，relatively mild tinnitus; 25~50,significant problems with tinnitus; ≥50, tinnitus severe enough ）. method 2:no effect on tinnitus was showed "0"; symptomatic alleviation was showed "1";and tinnitus disappear was showed "2"

Full Information

NCT ID

NCT03101722

First Posted

March 7, 2017

Last Updated

March 16, 2022

Sponsor

Zhijun Bao

1. Study Identification

Unique Protocol Identification Number

NCT03101722

Brief Title

Effects of Huperzine A on Presbycusis(Δ,kHz, dB,MMSE, AD)

Official Title

Effects of Huperzine A on Presbycusis-related Subjective Tinnitus and Cognitive Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

May 15, 2017 (Actual)

Primary Completion Date

May 15, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zhijun Bao

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To investigate the effects of huperzine A on tinnitus suppression, hearing and cognitive function protection in patients with presbycusis-related subjective tinnitus and cognitive impairment.

Detailed Description

This study is a randomized, controlled trial. 60 eligible participants in total will be recruited. Participants in each group will be evenly and randomly assigned to the huperzine A subgroup and control subgroup using simple randomization method. Participants in the treatment subgroup will receive huperzine A (a dose of 0.2 mg/time, 2 times/day) with basic treatment and health education(BTHE), and those in the control subgroup will receive BTHE only. The primary outcome (auditory function) and secondary outcomes (tinnitus, cognitive symptom and quality of life) will be evaluated at baseline, 3-, 6-, 12-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Presbycusis, Tinnitus, Cognitive Impairment

Keywords

presbycusis, tinnitus, cognitive impairment, Huperzine A, age-related hearing impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The studies were divided into 2 groups: Control subgroup and huperzine A group.The study is a single-center, randomized, basic treatment and health education controlled trial, with minimized allocation of patients to one of the two groups. For the study of tinnitus intervention, there is a 3 to 12 month follow-up.

Masking

Care Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Huperzine A intervention

Arm Type

Experimental

Arm Description

Huperzine A intervention: Huperzine A with a dose 0.1~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education

Arm Title

control

Arm Type

Sham Comparator

Arm Description

Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.

Intervention Type

Drug

Intervention Name(s)

BTHE and Huperzine A

Other Intervention Name(s)

acetylcholinesterase inhibitor

Intervention Description

huperzine A intervention

Intervention Type

Other

Intervention Name(s)

BETH

Intervention Description

basic treatment and health education

Primary Outcome Measure Information:

Title

hearing function protection

Description

Time Frame

1 years

Secondary Outcome Measure Information:

Title

global cognitive function protection

Description

Time Frame

1 years

Title

special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands

Description

MMSE scale in different domains (MMSE SCALE, 0-30)

Time Frame

1 years

Title

Tinnitus suppression

Description

Time Frame

1 years

Other Pre-specified Outcome Measures:

Title

adverse events related to treatment of Huperzine A

Description

All participants (including with tinnitus and without tinnitus) will be observed gastrointestinal side effects (nausea, vomiting diarrhea)in yes or no, dizziness, fatigue and insomnia in yes or no

Time Frame

1years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (1) 60 to 85 years old; (2) Mild-to-moderate sensorineural hearing loss (the pure tone averaged across octave frequencies between 0.25 to 4kHz of 26-70 dB HL), with subjective tinnitus, subjective cognitive decline or mild cognitive impairment; (3) Able to tolerate huperzine A treatment; (4) more than 3 months' experience of constant tinnitus; (5) Tinnitus Handicap Inventory score values >10; (6) No participation in any other clinical trial in the past 3 months; (7) Able to accomplish relevant tests and follow-up. Exclusion Criteria: (1) Conductive hearing loss; (2) current (3+ months) hearing aid(s) user; (3) Dependence due to poor physical activity; (4) Allergic to huperzine A; (5) History of malignancy within 5 years or other serious medical conditions before screening, including severe bradycardia, hypotension, angina, asthma, ileus, renal insufficiency, neurological diseases (e.g. epilepsy), psychiatric disorder (e.g. schizophrenia, severe depression and anxiety); (6) Acute brain trauma and stroke within 2 weeks; (7) history of general pain disorder and the use of pain relief drugs on a regular basis; (8) Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before investigation starts. (9) Individuals simultaneously or previously (within 30 days prior to investigation start) participate in a clinical investigation using experimental drugs or devices. (10) Ongoing serious life event; (11) Vision impairment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

zhuowei yu, MD

Organizational Affiliation

Shanghai Institute of Geriatrics and Gerontology, Shanghai Key Laboratory of Clinical Geriatrics, Huadong Hospital, and Research Center of Aging and Medicine, Shanghai Medical College, Fudan University, Shanghai 200040, China.

Official's Role

Study Director

Facility Information:

Facility Name

Huadong Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Effects of Huperzine A on Presbycusis(Δ,kHz, dB,MMSE, AD)

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