Last reviewed · How we verify
NCT05670158: PERILOTO
Study on the Inner Ear Immunisation Post-cohlear Implantation and Perilymph Molecular Profiling in Sensorineural Hearing Loss
NA trial testing Blood sampling in Sensorineural Hearing Loss in 80 participants. Currently enrolling.
1 March 2026
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 80 |
| Start date | 7 December 2023 |
| Primary completion | 1 March 2026 |
| Estimated completion | 1 March 2027 |
| Sites | 1 location across France |
Drugs / interventions tested
- Blood sampling — full drug profile →
- Perilymph sampling
Conditions studied
- Sensorineural Hearing Loss — all drugs for Sensorineural Hearing Loss →
Sponsor
University Hospital, Montpellier
Who can join
18 and older, any sex, with Sensorineural Hearing Loss. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Expression levels of proteins and metabolites in the perilymph before surgery in the 2 groups of implanted patients
Time frame: Before cochlear implantation surgery (V1)
Expression levels of proteins and metabolites identified by high-resolution mass spectrometry (Lc-HRMS) in the perilymph of group 1, "delayed residual hearing loss" and group 2, "maintained residual hearing" patients, collected before cochlear implantation surgery -
Expression levels of proteins and metabolites in the blood before surgery in the 2 groups of implanted patients
Time frame: Before cochlear implantation surgery (V1)
Expression levels of proteins and metabolites identified by high-resolution mass spectrometry (Lc-HRMS) in the blood of group 1 "delayed residual hearing loss" and group 2 "maintained residual hearing" patients, collected before cochlear implantation surgery
Sponsor's own description
Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation. Although the mechanisms involved in the residual audition loss remain unknown, animal experiments suggest the role of inflammatory or immune reaction in the cochlea. The goal of this project is to search in the perilymph (a fluid which fills the scala vestibuli and scala tympani of the cochlea) some predictive biomarkers of the residual hearing loss using modern proteomics and immunological techniques. A parallel search for blood biomarkers of post-implantation residual hearing loss and for molecular and cellular evidences of immune response to cochlear implantation will be performed. The study will recruit 50 subjects-candidates for cochlear implantation surgery; 30 normally hearing individuals eligible for other types of otological interventions will form a control group. For all the participants blood samples will be collected and preserved. In addition, the perilymph sampling will be performed during cochlear implantation surgery. This project relies on the calculation that from 50 patients post-cochlear implantation, 15 patients will form a group with maintained residual hearing and 15 will display delayed hearing loss. For these 30 subjects together with the control group the blood biomarkers search will be performed. For the group of implanted patients, the follow-up will last for 12 months with 6 visits in total : * the inclusion visit V0 during which the study will be presented and the consent form will be signed * the surgery visit V1 with blood sample and perilymph collection * the activation visit V2, 1 month ± 1 week after V1, visit V3 3 months ± 7 days after V1, V4 6 months ± 7 days after V1, V5 12 months ± 1 month after V1. During each of this visit blood sampling will be performed. For the control group, the follow up will be 6 months long with 4 visits in total arranged during the routine follow-up appointments: * the inclusion visit V0 during which the study will be presented and the consent form will be signed * the surgery visit V1, the 1 month visit V2 and the 6 months visit V3 during which the blood sampling will be performed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05670158
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Blood sampling
Trials testing the same drug.
- NCT07372859 — Women's Heart: Impact of Ultra-endurance and Hormonal Profile on Cardiac and Systemic Inflammatory Parameters in Female · NA · not yet recruiting
- NCT07237984 — Colorectal Omics and ofCS Proteoglycans (COCO) in Screening and a Diagnostic Pathway · not yet recruiting
- NCT06544018 — Circadian Rhythm Deregulation in Patients With CAPS · NA · recruiting
- NCT07245550 — Thyroid and Adrenal Disorders in ICU · not yet recruiting
- NCT07033091 — Prevalence of Human Papillomavirus (HPV) in a Healthy Population: A Feasibility Study of Oropharyngeal Cancer Screening · NA · recruiting
Other recruiting trials for Sensorineural Hearing Loss
Currently open trials in the same condition.
- NCT07505667 — Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss · NA · recruiting
- NCT06507007 — Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner Syndrome · recruiting
- NCT07364747 — Protective Effect of Acetylcysteine Against Cisplatinum-Induced Ototoxicity: A Randomized Controlled Trial · Phase 2 · recruiting
- NCT06495268 — Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing · NA · active not recruiting
- NCT06226558 — Long-Term Outcomes of Children With Congenital CMV in New York State · recruiting
Other University Hospital, Montpellier trials
Trials by the same sponsor.
- NCT07524127 — Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Pol · NA · not yet recruiting
- NCT07255495 — Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism · NA · not yet recruiting
- NCT07534189 — Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis · NA · not yet recruiting
- NCT07515638 — Immun4Cure Cohort of Autoimmune Diseases · not yet recruiting
- NCT07406516 — Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05670158 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 15 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05670158.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing