Clinical trial NCT03101722: Effects of Huperzine a on Presbycusis(Δ,kHz, DB,MMSE, AD)
Official title: Effects of Huperzine a on Presbycusis-related Subjective Tinnitus and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Presbycusis
Tinnitus
Cognitive Impairment
Keywords: presbycusis
tinnitus
cognitive impairment
Huperzine A
age-related hearing impairment
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: hearing function protection
timeFrame: 1 years
Secondary outcomes:
measure: global cognitive function protection
timeFrame: 1 years
measure: special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands
timeFrame: 1 years
measure: Tinnitus suppression
timeFrame: 1 years
Other outcomes:
measure: adverse events related to treatment of Huperzine A
timeFrame: 1years
Locations:
city: Shanghai
country: China
facility: Huadong Hospital
state: Shanghai
Study officials:
affiliation: 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.
name: zhuowei yu, MD
role: STUDY_DIRECTOR
References: