Cognitive Impairment Clinical Trial
Official title:
Effects of Huperzine A on Presbycusis-related Subjective Tinnitus and Cognitive Impairment
Verified date | March 2022 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | December 1, 2023 |
Est. primary completion date | May 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Huadong Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Zhijun Bao |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | 1years | |
Primary | hearing function protection | All participants (including with tinnitus and without tinnitus) will report in the measure.
? value of averaged hearing threshold = re-test threshold - initial threshold, ? value of averaged hearing threshold = 0 showed good responders, and > 0 showed poor responders. |
1 years | |
Secondary | global cognitive function protection | All participants (including with tinnitus and without tinnitus) will report in the outcome measure.
?MMSE = re-test MMSE - initial MMSE, ?MMSE< 0 showed poor responders and hearing threshold = 0 showed good responders; and > 0 showed poor responders ?MMSE= 0 showed good responders |
1 years | |
Secondary | 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) | 1 years | |
Secondary | 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" | 1 years |
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