An interventional study of BTHE and Huperzine A and BETH in Presbycusis, Tinnitus and Cognitive Impairment, sponsored by Zhijun Bao. Enrolling by invitation at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Zhijun Bao · Not applicable, Interventional, and Treatment
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.
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.
(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.
Huperzine A intervention: Huperzine A with a dose 0.1\~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education
Drug: BTHE and Huperzine A · Other: BETH
Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.
Drug: BTHE and Huperzine A · Other: BETH
huperzine A intervention
Also known as: acetylcholinesterase inhibitor
basic treatment and health education
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.
Time frame: 1 years
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
Time frame: 1 years
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)
Time frame: 1 years
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"
Time frame: 1 years
adverse events related to treatment of Huperzine A
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
Plan to share: Undecided
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