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Enrolling by Invitation

NCT Number: NCT03101722

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BTHE and Huperzine A

Drug

huperzine A intervention

Other names: acetylcholinesterase inhibitor

BETH

Other

basic treatment and health education

Primary outcomes

  1. hearing function protection

    Time frame: 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 outcomes

  1. global cognitive function protection

    Time frame: 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

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

    Time frame: 1 years

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

  3. Tinnitus suppression

    Time frame: 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"

Other outcomes

  1. adverse events related to treatment of Huperzine A

    Time frame: 1years

    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

Sponsors and collaborators

Lead sponsor

Zhijun Bao

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2030
Study completion
2030
First posted
Apr 5, 2017
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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