Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03101722
Other study ID # huadong FudanU
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date May 15, 2017
Est. completion date December 1, 2023

Study information

Verified date March 2022
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
BTHE and Huperzine A
huperzine A intervention
Other:
BETH
basic treatment and health education

Locations

Country Name City State
China Huadong Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Zhijun Bao

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT02122198 - Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women N/A
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Suspended NCT05542238 - The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury N/A
Terminated NCT04493957 - Evaluation of an Educational Program in the Prevention of the Driving Risks in Patients With Neurocognitive Disorders : ACCOMPAGNE N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Not yet recruiting NCT05068323 - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients N/A
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Completed NCT04713384 - Remote Bimanual Virtual Rehabilitation Post CVD N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Completed NCT03698695 - A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers Phase 1
Not yet recruiting NCT05552729 - Effects of Different Doses of Vitamin D on Cancer-related Cognitive Impairment in Patients With Gastrointestinal Tumors Phase 1/Phase 2
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT03187353 - IMProving Executive Function Study Phase 4
Completed NCT03301402 - Air Purifier to Improve Endothelial Function and Carotid Intima Thickness N/A
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Recruiting NCT04907565 - Impact of Obesity on Post-operative Cognitive Dysfunction: Role of Adipose Tissue
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A
Recruiting NCT05030285 - Telehealth Psychotherapy for Anxiety in Persons With Cognitive Impairment N/A