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

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ClinicalTrials.gov Identifier: NCT03101722
Recruitment Status : Enrolling by invitation
First Posted : April 5, 2017
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Zhijun Bao, Fudan University

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.

Condition or disease Intervention/treatment Phase
Presbycusis Tinnitus Cognitive Impairment Drug: BTHE and Huperzine A Other: BETH Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Huperzine A on Presbycusis-related Subjective Tinnitus and Cognitive Impairment
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 15, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Huperzine A intervention
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
huperzine A intervention
Other Name: acetylcholinesterase inhibitor

Other: BETH
basic treatment and health education

Sham Comparator: control
Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.
Drug: BTHE and Huperzine A
huperzine A intervention
Other Name: acetylcholinesterase inhibitor

Other: BETH
basic treatment and health education




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101722


Locations
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China, Shanghai
Huadong Hospital
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Zhijun Bao
Investigators
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Study Director: zhuowei yu, MD 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.
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Responsible Party: Zhijun Bao, Huadong hospital, Fudan University, Clinical professor of Otolaryngology, Fudan University
ClinicalTrials.gov Identifier: NCT03101722    
Other Study ID Numbers: huadong FudanU
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhijun Bao, Fudan University:
presbycusis
tinnitus
cognitive impairment
Huperzine A
age-related hearing impairment
Additional relevant MeSH terms:
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Tinnitus
Presbycusis
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural
Hearing Loss
Huperzine A
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents