Effects of Huperzine a on Presbycusis(Δ,kHz, DB,MMSE, AD)

Not Applicable

• Conditions: Presbycusis; Tinnitus; Cognitive Impairment
• Interventions: Drug: BTHE and Huperzine A; Other: BETH

• Registration Number: NCT03101722
• Lead Sponsor: Zhijun Bao

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.

Study Timeline

• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-05
• Study Start: 2017-05-15
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-28
• Last Update Posted: 2024-10-01
• Primary Completion: 2030-09-15
• Study Completion: 2030-09-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	BETH	Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.
Huperzine A intervention	BTHE and Huperzine A	Huperzine A intervention: Huperzine A with a dose 0.1\~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education
Huperzine A intervention	BETH	Huperzine A intervention: Huperzine A with a dose 0.1\~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education
control	BTHE and Huperzine A	Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.

Primary Outcome Measures

Name	Time	Method
hearing function protection	1 years	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

Name	Time	Method
special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands	1 years	MMSE scale in different domains (MMSE SCALE, 0-30)
global cognitive function protection	1 years	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
Tinnitus suppression	1 years	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"

Trial Locations

Locations (1)

Huadong Hospital; 🇨🇳 Shanghai, Shanghai, China