Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05582148
Other study ID # 38RC22.0289
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date December 20, 2024

Study information

Verified date October 2022
Source University Hospital, Grenoble
Contact Ashley BAGUANT, MD
Phone +33476765662
Email abaguant@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with unilateral Meniere Disease often a distortion that causes difficulties to provide hearing aids to these patients. Those patients have two main problems: disorders in noise comprehension due to interaural threshold difference and increase in the distortion during dizziness crisis. Due to these problems, some people cannot be fitting with hearing aids because the compression needed is too high or the discomfort in noise is not bearable for patients. Our aim is to evaluate and to propose a way to adjust hearing aids to restore binaural hearing with comfort.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date December 20, 2024
Est. primary completion date November 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age over 18 y.o - Meniere disease as define by the Barany Society - Unilateral deafness with a threshold over 50dB - Normal ear with a threshold above 30dB - Interaural threshold difference of at least 30dB - Patient who has already an hearing aids and satisfied with it Exclusion Criteria: - Absence of consent of the patient or not able to give it - Patient with hearing aids well fitted

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hearing aids fitting
Fitting hearing aids and evaluating the results at 6 months

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

References & Publications (6)

Cubick J, Buchholz JM, Best V, Lavandier M, Dau T. Listening through hearing aids affects spatial perception and speech intelligibility in normal-hearing listeners. J Acoust Soc Am. 2018 Nov;144(5):2896. doi: 10.1121/1.5078582. — View Citation

Havia M, Kentala E, Pyykkö I. Hearing loss and tinnitus in Meniere's disease. Auris Nasus Larynx. 2002 Apr;29(2):115-9. — View Citation

Hood JD. Speech discrimination in bilateral and unilateral hearing loss due to Ménière's disease. Br J Audiol. 1984 Aug;18(3):173-7. — View Citation

McNeill C, McMahon CM, Newall P, Kalantzis M. Hearing aids for Ménière's syndrome: implications of hearing fluctuation. J Am Acad Audiol. 2008 May;19(5):430-4. — View Citation

Sato G, Sekine K, Matsuda K, Ueeda H, Horii A, Nishiike S, Kitahara T, Uno A, Imai T, Inohara H, Takeda N. Long-term prognosis of hearing loss in patients with unilateral Ménière's disease. Acta Otolaryngol. 2014 Oct;134(10):1005-10. doi: 10.3109/00016489 — View Citation

Valente M, Mispagel K, Valente LM, Hullar T. Problems and solutions for fitting amplification to patients with Ménière's disease. J Am Acad Audiol. 2006 Jan;17(1):6-15. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the comprehension in noise Evaluation with the FrMatrix test of the noise comprehension at 6 months 6 months
Secondary Correlation between the ear recruitment and the settings of the hearing aids Correlation between the fowler test and the MPO modifications 6 months
See also
  Status Clinical Trial Phase
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Not yet recruiting NCT05973669 - MED-EL Remote Care Multi-Center Feasibility Study N/A
Completed NCT04601909 - FX-322 in Adults With Age-Related Sensorineural Hearing Loss Phase 1
Active, not recruiting NCT04479761 - Sensory Integration of Auditory and Visual Cues in Diverse Contexts N/A
Recruiting NCT05043207 - A Study Protocol for the Validation of UAud in a Clinical Setting. N/A
Recruiting NCT04070937 - Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy
Recruiting NCT04066270 - Inventory of Radiological and Vestibular Function in Cochlear Implant Candidates
Completed NCT03512951 - Subjective Evaluation of a Sound Processing Method for Hearing Aids on Auditory Distance Perception N/A
Completed NCT05855005 - Direct-to-Consumer Hearing Aids and Listening Effort N/A
Recruiting NCT05599165 - Speech Perception in Bimodal Hearing N/A
Completed NCT05101083 - Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids N/A
Completed NCT05521308 - Investigating Hearing Aid Frequency Response Curves N/A
Completed NCT05072457 - Benefit of Assistive Listening Device for Lateralization N/A
Recruiting NCT05776459 - Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) Phase 2
Completed NCT05086276 - FX-322 in Adults With Acquired Sensorineural Hearing Loss Phase 2
Recruiting NCT06058767 - Preschool Hearing Screening N/A
Completed NCT05180630 - Sound Quality Comparisons With Different Hearing Aid Couplings and Venting Systems N/A
Completed NCT03613909 - Acceptance of the CP950 Sound Processor N/A
Active, not recruiting NCT03352154 - Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants N/A
Completed NCT04629664 - FX-322 in Adults With Severe Sensorineural Hearing Loss Phase 1