Mitochondrial Genetics of Presbycusis

Presbycusis Clinical Trial

— MITOPRES  

Official title:

Mitochondrial Genetics of Presbycusis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720964
• Other study ID #: 49RC18_0148
• Status: Recruiting
• Start date: April 2019
• Est. completion date: November 2023

Study information

• Verified date: April 2019
• Source: University Hospital, Angers
• Contact: Dr Sophie Boucher
• Phone: 0241353989
• Email: sophie.boucher[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main goal of this study is to identify mitochondrial mutations associated with presbycusis. Patients affected by severe presbycusis and normal hearing controls (according to ISO7029 norm) will be enrolled if satisfying inclusion criteria (aged from 40 to 80 years old) in existing biocollections in the University Hospital of Angers. After DNA extraction, the mitochondrial genome will be sequenced and data in silico analysed.

Description:

The study will be proposed to patients consulting in the ENT department of the University Hospital of Angers. After clinical examination and audiometry recording, the eligibility criteria will be checked and inclusion in biocollections proposed. Presbycusis affected subjects will be enrolled in "Mitochondrial Disease biocollection" and normal hearing controls in "Healthy Volunteer biocollection". These biocollections have been approved by the board comitee "Centre de Protection des Personnes".

After DNA extraction and mitochondrial sequencing, candidate variants will be selected by in silico analysis. The presence of mitochondrial variants in both groups (presbycusis and control) will be compared in multivariate analysis if needed.

The nuclear DNA may be sequenced in order to complete the previous analysis and look for any candidate variant .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• age related hearing loss more severe than the predicted hearing thresholds according to the norm ISO7029, for the presbycusis population;

• normal hearing according to norm ISO7029 for the control population

Exclusion Criteria:

• deafness diagnosed before 40 years old

• exclusion criteria of one of the biocollection

Related Conditions & MeSH terms

• Age Related Hearing Loss
• Hearing Loss
• Presbycusis

Locations

Country	Name	City	State
France	UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	identification of clinical features predicting some presbycusis forms	analysis of audiometric data after genetic analysis will be performed	the analysis will be conducted at the end of the inclusion of the 200 patients
Primary	identification of mitochondrial mutations associated with presbycusis	Enrichment analysis will be perfomed with CHI2 test after Benjamini correction.	the analysis will be conducted at the end of the inclusion of the 200 patients
Secondary	identification of genomic variants associated with presbycusis	enrichment of genomic variants will be analysed	the analysis will be conducted at the end of the inclusion of the 200 patients
Secondary	identification of DNA variants associated with environmental susceptibility	subgroup analysis will be performed in accordance with environmental exposition	the analysis will be conducted at the end of the inclusion of the 200 patients