PresbycusisNCT03101722
Effects of Huperzine a on Presbycusis(Δ,kHz, DB,MMSE, AD)
A study testing BTHE and Huperzine A and BETH in people with Presbycusis and Tinnitus, run by Zhijun Bao at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Presbycusis, Tinnitus, Cognitive Impairment
- What is being tested?
- BTHE and Huperzine A and BETH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2017to 15 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Huperzine a on Presbycusis-related Subjective Tinnitus and Cognitive Impairment
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.
Read the 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.
- Conditions
- Presbycusis, Tinnitus, Cognitive Impairment
- Being tested
- BTHE and Huperzine A, BETH
- Keywords
- presbycusis, tinnitus, cognitive impairment, Huperzine A, age-related hearing impairment
- Medical subject headings
- Presbycusis, Tinnitus, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTHE and Huperzine ADrug
Also called acetylcholinesterase inhibitor
huperzine A intervention
BETHOther
basic treatment and health education
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: BTHE and Huperzine A; Other: BETH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 years
Secondary outcomes (3)
global cognitive function protection
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
Measured: 1 years
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)
Measured: 1 years
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"
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start15 May 2017
- Primary completion15 Sep 2030 (estimated)
- Study completion15 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbycusisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhijun Bao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhijun Bao, Fudan University
- Investigators
- zhuowei yu, MD, Study director, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101722
- Sponsor's protocol ID
- huadong FudanU
- Status last verified
- Sep 2024
- First submitted
- 7 Mar 2017
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Huperzine a on Presbycusis-related Subjective Tinnitus and Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03101722
- Acronym / sponsor ID
- huadong FudanU
- Conditions
- Presbycusis, Tinnitus, Cognitive Impairment
- Keywords
- presbycusis, tinnitus, cognitive impairment, Huperzine A, age-related hearing impairment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhijun BaoUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Sep 2030 (estimated)
- Study completion
- 15 Sep 2030 (estimated)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Huperzine A intervention | Experimental | Drug: BTHE and Huperzine A, Other: BETHHuperzine A intervention: Huperzine A with a dose 0.1~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education |
| control | Sham comparator | Drug: BTHE and Huperzine A, Other: BETHParticipants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTHE and Huperzine AAlso: acetylcholinesterase inhibitorhuperzine A intervention | Drug | Huperzine A intervention, control |
| BETHbasic treatment and health education | Other | Huperzine A intervention, control |
Primary outcome
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.
3 secondary outcomes
global cognitive function protection
Time frame: 1 years
special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands
Time frame: 1 years
Tinnitus suppression
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
zhuowei yu, MD study director
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTHE and Huperzine A and BETH in people with Presbycusis and Tinnitus, run by Zhijun Bao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing function protection (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.