Clinical Trial: Effects of Hearing Rehabilitative Interventions and Huperzine A on Presbycusis(Δ,kHz, dB,MMSE, AD)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Combination of Hearing Rehabilitative Interventions and Huperzine A for Presbycusis Related Tinnitus Suppression, Hearing and Cognitive Function Protection in

Brief Summary: To investigate the effects of hearing aid, huperzine A and combination of hearing aid and huperzine A on tinnitus suppression, hearing and cognitive function protection in patients with presbycusis

Detailed Summary: To continuously recruit about 150 patients with presbycusis and tinnitus and about 400 patients with presbycusis in our hospital of Fudan university.
Sponsor: Zhijun Bao

Current Primary Outcome: hearing function protection [ Time Frame: 1-3 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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • global cognitive function protection [ Time Frame: 3 years ]

    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

  • special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands [ Time Frame: 3 years ]
    MMSE scale in different domains (MMSE SCALE, 0-30)
  • Tinnitus suppression [ Time Frame: 3-6 months ]
    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"


Original Secondary Outcome: Same as current

Information By: Fudan University

Dates:
Date Received: March 7, 2017
Date Started: May 15, 2017
Date Completion: December 1, 2021
Last Updated: April 4, 2017
Last Verified: March 2017