Vitamin mediated hearing preservation in cochelar implant patients receiving different electrode lengths

Phase 1

• Conditions: Cochlear implant patients in whom a cochlear implant preserving residual hearing is medically indicated; MedDRA version: 14.1Level: PTClassification code 10019245Term: Hearing impairedSystem Organ Class: 10013993 - Ear and labyrinth disorders; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2012-005002-22-DE
• Lead Sponsor: Hannover Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-10
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 18 years of age or older
2. No or little benefit of conventional hearing aid, defined as preoperative auditory speech understanding of less or equal 60% in Freiburger monosyllables at 65 dB SPL, best aided in the ear to be implanted
3. Residual hearing better or equal than 80 dB HL at 125 and 250 Hz and better or equal than 90 dB HL at 500 Hz in the ear to be implanted
4. Ability to understand the study procedures, possible risks and benefits, and to give informed consent
5. Informed Consent is signed
6. Patients must agree not to use daily multi-vitamins or other supplements during the course of the study, and beginning at least 48 hours prior to first intake of the study medication
7. Female patients =50 years of age at the day of inclusion who have been postmenopausal since at least 1 year
OR
female patients who have a negative hCG serum pregnancy test and meet one or more of the following criteria:
- 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy
- Using proven oral, injected or implanted hormonal contraceptive methods
- Intrauterine Device (IUD) or intrauterine system (IUS)
- Barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam / gel / film / cream / suppository)
- Male sterilisation (if the absence of sperm in the ejaculate is documented. For female participants the vasectomized male partner should be the sole sexual partner for that subject)
- True abstinence (Periodic abstinence and interruptus are not acceptable methods of contraception)
- Only female sexual partners

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 177
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 123

Exclusion Criteria

Key Exclusion Criteria:
1. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and imaging (e.g. DVT)
2. Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and imaging (e.g. DVT)
3. Medical or psychological conditions which contraindicate surgery (e.g. active middle ear infections, tympanic membrane perforation)
4. Pregnancy or lactation
5. Additional handicaps that would prevent participation in evaluations
6. Contraindications for ACEMg:
6.1 hepatopathy (transaminases or ?-GT >= 2 x ULN (Upper Limit of Normal))
6.2 severe renal insufficiency (Serum creatinine > 2 x
ULN)
6.3 disposition to kidney stones
6.4 iron-storage disease (thalassemia, hemochromatosis, sideroblastic anaemia)
6.5 co-medication with vitamin K-antagonists
6.6 heavy smoking (= 20 cigarettes per day)
7. Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the study begins

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified