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

NCT03101722 | Enrolling By Invitation

• 1 other identifier: huadong FudanU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbycusis; Tinnitus; Cognitive Impairment

Keywords

presbycusis; tinnitus; cognitive impairment; Huperzine A; age-related hearing impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  1 years

Secondary Outcomes (3)

• global cognitive function protection

  1 years

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

  1 years

• Tinnitus suppression

  1 years

Other Outcomes (1)

• adverse events related to treatment of Huperzine A

  1years

Study Arms (2)

Huperzine A intervention

EXPERIMENTAL

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

control

SHAM COMPARATOR

Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.

Drug: BTHE and Huperzine A; Other: BETH

Interventions

BTHE and Huperzine A DRUG

huperzine A intervention

Also known as: acetylcholinesterase inhibitor

Huperzine A intervention; control

BETH OTHER

basic treatment and health education

Huperzine A intervention; control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Zhijun Bao: lead

Study Sites (1)

Huadong Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Presbycusis; Tinnitus; Cognitive Dysfunction

Interventions

huperzine A; Cholinesterase Inhibitors

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs

Study Officials

• 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.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Huadong hospital, Fudan University, Clinical professor of Otolaryngology

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 5, 2017
• Study Start: May 15, 2017
• Primary Completion (Estimated): September 15, 2030
• Study Completion (Estimated): September 15, 2030
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CN (1)