[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cochlear-synaptopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cochlear-synaptopathy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100629302","phase-1-a-study-testing-the-safety-and-possible-benefits-of-an-ear-injection-of-a-new-compound-paliroden-in-people-with-type-2-diabetes-who-have-difficulty-understanding-speech-in-noisy-situations-100629302",false,"NCT07472907","A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations","A Randomized, Double-blind, Placebo-controlled, Ascending Volume Phase 1B\u002F2A Clinical Trial to Investigate the Safety and Efficacy of a Single Transtympanic Injection of CIL001 (Paliroden) for the Treatment of Cochlear Synaptopathy in Participants With type2 Diabetes","RESPLAND","Inclusion Criteria:\n\n1. Signed and dated informed consent form\n2. Aged between 45 and 75 years old (inclusive) at the time of screening\n3. Established type 2 diabetes as determined by 7% ≤ hemoglobin A1c (HbA1c) ≤ 9% and diabetes duration of at least 5 years\n4. Be considered as reliable and capable of adhering to the protocol, according to the judgment of the Investigator\n5. Participants must be native speakers of the official language(s) of the country in which the study assessments are conducted.\n6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test upon entry into this study. In addition, they must agree to use highly effective contraception methods, as defined by regulatory guidance (e.g., combined hormonal contraception, intrauterine device, or surgical sterilization), from the screening visit, for the duration of study treatment and for 30 days after dosing.\n\n   The following audiology assessments, if not performed on the same day as the review of the previous criteria (e.g., when the participant's first visit does not take place at the ENT site), may be scheduled on different days within a maximum interval of 14 days after the first screening visit and must be completed at least 21 days before the baseline visit.\n7. Normal hearing as defined by PTAv (0.5-1-2kHz-4Khz) \\\u003C25dB in both ears.\n8. Up to mild hearing loss in the high-frequency range (PTAvHF (4-6-8kHz) \\\u003C40dB) in both ears.\n9. Speech-in-noise deficit (at least 3dB SNR loss in comparison to normative value of the Matrix test) in both ears.\n\nExclusion Criteria:\n\n1. MoCA score \\\u003C 26\n2. Known otologic pathology (e.g., History of autoimmune hearing loss, radiation-induced hearing loss, fluctuating hearing, endolymphatic hydrops, or Menière's disease in either ear)\n3. Presence of middle ear pathology (e.g., otitis media, tympanic membrane perforation, etc.)\n4. History of platinum-based chemotherapy\n5. Previous or concurrent malignancies that require treatment and are not clinically stable\n6. Current evidence or history of retrocochlear pathology (e.g., acoustic neuroma)\n7. History of otologic surgery (apart from tympanostomy tube insertion if more than one year prior to inclusion visit)\n8. Abnormal otoscopy as defined by less than 90% of the tympanic membrane visible (e.g., cerumen ear plug, ear drum perforation). In case of cerumen plugs not affecting the hearing results, a removal must be scheduled before V1 (baseline\u002Finclusion).\n9. Hearing aids and cochlear implants.\n10. History of cancer treated by platinum-based chemotherapy.\n11. Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential, or planning to become pregnant during the study\n12. Liver Enzyme Lab Outcomes:\n\n    1. Bilirubin \\> 2 times the upper limit of normal (ULN)\n    2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST\u002FALT) \\>5 times ULN.\n    3. Gamma glutamyltransferase (GGT) \\> 5 times ULN\n13. Maternally Inherited Diabetes\n14. Congenital hearing loss\n15. Untreated hypothyroidism\n16. Adult individual under legal protection as defined by applicable regulations (e.g., persons deprived of liberty, hospitalized without consent, unable to provide informed consent, or placed under legal guardianship or curatorship)\n17. Concurrent participation in another clinical study or participation in another trial involving experimental drug within 30 days or five half-lives of the experimental drug (whichever was longer) prior to screening visit (V0).\n18. Diagnosed anxiety disorders, psychosis, depression, schizophrenia, attempted suicide, or other significant psychiatric conditions that could impact their ability to cooperate and comply with the study protocol\n19. Major surgery that may impact the study conduct or outcomes within eight weeks before screening or scheduled\u002Fplanned surgery within the time frame of the study","ALL","45 Years","75 Years",{"count":21,"type":22},135,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes. Neuroinflammation in diabetes can cause auditory nerve damage (cochlear synaptopathy) which first translates into speech-in-noise intelligibility deficit. CIL001 is a neurotrophic small molecule that aims to repair auditory nerve when applied locally by transtympanic injection. Transtympanic injection of paliroden is anticipated to improve the symptoms of cochlear synaptopathy. Furthermore, by addressing auditory or vestibular dysfunction early and effectively, this approach may contribute to limiting or delaying, over the long term, the onset of secondary neurological disorders, such as dementia.",[29],"Cochlear Synaptopathy",[31,32],"hearing","diabetes","NOT_YET_RECRUITING","2026-03-10",{"date":36,"type":37},"2026-03-16","ACTUAL",{"date":39,"type":22},"2026-08",{"date":41,"type":22},"2027-12",{"name":43,"class":44},"Cilcare SAS","INDUSTRY",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100610642","relationship-between-ls-chirp-abr-and-speech-in-noise-skills-in-hidden-hearing-loss-100610642","NCT07230236","Relationship Between LS Chirp ABR and Speech-in-Noise Skills in Hidden Hearing Loss","Investigation of the Relationship Between LS Chirp ABR and Comprehension In Noise Skills In Individuals With Suspected Hidden Hearing Loss","Inclusion Criteria (Control group):\n\n* Being between 20 and 60 years of age,\n* Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),\n* Having no tinnitus or auditory complaints,\n* Scoring 21 or above on the MoCA test,\n* Having no emotional or neurological problems that could interfere with the tests.\n\nExclusion Criteria (Control group):\n\n* Presence of peripheral and\u002For central hearing loss,\n* Presence of somatosensory tinnitus,\n* Presence of emotional and\u002For neurological problems that could interfere with the tests.\n\nInclusion Criteria (First study group):\n\n* Being between 20 and 60 years of age,\n* Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),\n* Having a chronic tinnitus complaint (≥3 months),\n* Scoring 21 or above on the MoCA test,\n* Having no emotional or neurological problems that could interfere with the tests.\n\nExclusion Criteria (First study group):\n\n* Presence of peripheral and\u002For central hearing loss,\n* Presence of somatosensory tinnitus,\n* Presence of emotional and\u002For neurological problems that could interfere with the tests.\n\nInclusion Criteria (Second study group):\n\n* Being between 20 and 60 years of age,\n* Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),\n* Having no chronic tinnitus complaint,\n* Having an average score below 4.3 on the \"Speech Perception\" subscale of the Speech, Spatial and Qualities of Hearing Scale (SSQ),\n* Scoring 21 or above on the MoCA test,\n* Having no emotional or neurological problems that could interfere with the tests.\n\nExclusion Criteria (Second study group):\n\n* Presence of peripheral and\u002For central hearing loss,\n* Presence of somatosensory tinnitus,\n* Presence of emotional and\u002For neurological problems that could interfere with the tests.",true,"20 Years","60 Years",{"count":56,"type":22},63,"10 Months","OBSERVATIONAL","It is known that the underlying problem in Hidden Hearing Loss (HHL) is cochlear synaptopathy (CS) and that low-spontaneous-rate auditory nerve fibers play an important role in this pathology. Therefore, it is suggested that low-spontaneous-rate auditory nerve fibers are damaged in HHL. Consequently, LS CE-Chirp-evoked ABR and HINT, which assesses CS by presenting stimuli of varying intensities and characteristics to provide information about auditory nerve fibers, will be used to evaluate participants both objectively and subjectively.\n\nAim of the study:\n\nThe main aim of this study is to investigate the relationship between the amplitude and latency values obtained with LS CE-Chirp-stimulated ABR and the critical Signal-to-Noise Ratio (SNR) obtained from the Hearing in Noise Test (HINT) in individuals suspected of having HHL.\n\nHypotheses\n\nH0: In individuals suspected of having HHL, there is no relationship between the amplitude values of waves I, III, and V obtained with LS CE-Chirp ABR at 80, 90, and 100 dBnHL and the I\u002FV amplitude ratio and the critical SNR obtained from HINT.\n\nH1: In individuals suspected of having HHL, there is a relationship between the amplitude values of waves I, III, and V obtained with LS CE-Chirp ABR at 80, 90, and 100 dBnHL and the I\u002FV amplitude ratio, and the critical SNR obtained from HINT.\n\nExpected Results:\n\nThe study will reveal how LS CE-Chirp stimulation affects ABR results in individuals suspected of having HHL, and the relationship between these results and HINT results will be examined. In this way, HHL will be evaluated both objectively (LS CE-Chirp ABR) and subjectively (HINT). Based on the findings, scientific outputs such as publications or projects are targeted.\n\nImportance:\n\nHHL has recently attracted increasing attention as a condition that significantly affects daily life. In today's world, where noise and noisy environments are prevalent, disadvantages arise in many aspects, particularly in communication. Therefore, the findings obtained in this study may contribute to a better understanding of HHL.",[61,29],"Hidden Hearing Loss",[63,64,65,66],"hidden hearing loss","cochlear synaptopathy","Level-Specific (LS) Chirp ABR","Hearing In Noise Test (HINT)","RECRUITING","2025-11-14",{"date":70,"type":37},"2025-11-17",{"date":72,"type":37},"2025-08-20",{"date":74,"type":22},"2026-06-01",{"name":76,"class":77},"Istanbul University - Cerrahpasa","OTHER",1]