[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06102486":3,"trial-entities:NCT06102486":93,"trial-summary:NCT06102486":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":15,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":26,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":69,"locations":72,"central_contacts":88,"overall_officials":90,"references":91,"see_also_links":92},"NCT06102486","STUDY02002079","MCI Speech in Noise","Speech Perception in Noise as an Improved Marker for Neurocognitive Dysfunction","RECRUITING","2026-09-02","2026-08","2026-08-25","2024-05-18","Dartmouth-Hitchcock Medical Center","OTHER",null,"The purpose of this study is to determine whether people with MCI (Mild Cognitive Impairment) and healthy comparison subjects differ with respect to their ability to hear soft sounds and how their brain understands and processes sound. The investigators are also evaluating, within those with MCI, whether the hearing tests are associated with neurocognitive functioning. The investigators are interested in learning whether changes in cognition in those with MCI can be detected using tests of how the brain processes sound. The investigators hypothesize that participants with MCI will score worse on both hearing tests and neurocognitive tests than participants without MCI. Participants are asked to complete multiple types of hearing tests, take a series of neurocognitive tests, and complete a few questionnaires.",[18],"Mild Cognitive Impairment",[],"OBSERVATIONAL",[],{"count":23,"type":24},70,"ESTIMATED",[],[27,31,34,38],{"measure":28,"description":29,"timeFrame":30},"Hearing-in-Noise Test Performance","The performance for Hearing in Noise Tests (HINT) between energetic masking and 2-talker informational masking (IM). Performance will be measured by the lowest signal-to-noise ratio (volume at which sentences are presented compared to background noise volume) that can be heard by the participant.","1 time point (takes 15 minutes)",{"measure":32,"description":33,"timeFrame":30},"Triple Digit in Noise Test Performance","Performance for the behavioral Triple Digit (TDT) between energetic masking and 2-talker informational masking (IM). Performance will be measured by the lowest signal-to-noise ratio (volume at which digits are presented compared to background noise volume) that can be heard by the participant.",{"measure":35,"description":36,"timeFrame":37},"Size of auditory neural response in background noise","The change in amplitude of neural response between energetic masking and 2-talker informational masking (IM).","1 time point (takes 45 minutes)",{"measure":39,"description":40,"timeFrame":37},"Timing of auditory neural response in background noise","The change in latency of neural response between energetic masking and 2-talker informational masking (IM).",[],"ALL","55 Years","80 Years",true,{"inclusion":47,"exclusion":54,"raw_text":68},[48,49,50,51,52,53],"Adults diagnosed with or suspected to have MCI (for MCI group) or are cognitively normal (for Control group)","Absence of other risk factors that might affect CAP (Central Auditory Processing) performance (e.g., active ear infections, congenital developmental delay, severe hearing loss)","Age 55-80","Normal hearing sensitivity (\\\u003C40 dB HL Pure Tone Average (average of 500, 1000, 2000 Hz) thresholds bilaterally","Normal middle ear function defined by tympanometry (0.3-2.0 ml)","Native English speaker",[55,56,57,58,59,60,61,62,63,64,65,66,67],"Active ear infections or abnormal middle ear pathology","Other health condition prohibiting the completion of the CAP test battery","Mild to profound peripheral hearing loss (\\>40 dB (decibel) HL (hearing loss) Pure Tone Average (average of 500, 1000, 2000 Hz) bilaterally","Adults unable to consent","Individuals who are not yet adults (infants, children, teenagers)","Prisoners","History of CNS (Central Nervous System) disorder that might severely impact cognitive function (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, neurosyphilis, intracranial tumors, history of significant head trauma with loss of consciousness (≥30 min), and cerebrovascular disease)","Severe mental illness (e.g., schizophrenia, bipolar disorder)","Current, uncontrolled medical condition that could affect cognition (e.g., hypertension)","History of substance use disorder within the (other than nicotine\u002Fcaffeine)","Non-correctable severe hearing or vision loss","Use of \"Cognition Enhancing Drugs\"","Frequent, severe headaches (occasional headaches or migraines are fine)","Inclusion Criteria:\n\n* Adults diagnosed with or suspected to have MCI (for MCI group) or are cognitively normal (for Control group)\n* Absence of other risk factors that might affect CAP (Central Auditory Processing) performance (e.g., active ear infections, congenital developmental delay, severe hearing loss)\n* Age 55-80\n* Normal hearing sensitivity (\\\u003C40 dB HL Pure Tone Average (average of 500, 1000, 2000 Hz) thresholds bilaterally\n* Normal middle ear function defined by tympanometry (0.3-2.0 ml)\n* Native English speaker\n\nExclusion Criteria:\n\n* Active ear infections or abnormal middle ear pathology\n* Other health condition prohibiting the completion of the CAP test battery\n* Mild to profound peripheral hearing loss (\\>40 dB (decibel) HL (hearing loss) Pure Tone Average (average of 500, 1000, 2000 Hz) bilaterally\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* History of CNS (Central Nervous System) disorder that might severely impact cognitive function (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, neurosyphilis, intracranial tumors, history of significant head trauma with loss of consciousness (≥30 min), and cerebrovascular disease)\n* Severe mental illness (e.g., schizophrenia, bipolar disorder)\n* Current, uncontrolled medical condition that could affect cognition (e.g., hypertension)\n* History of substance use disorder within the (other than nicotine\u002Fcaffeine)\n* Non-correctable severe hearing or vision loss\n* Use of \"Cognition Enhancing Drugs\"\n* Frequent, severe headaches (occasional headaches or migraines are fine)",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"contacts":79,"geoPoint":85},"Space Medicine Lab at Dartmouth-Hitchcock Medical Center","Lebanon","New Hampshire","03756","United States",[80],{"name":81,"role":82,"phone":83,"email":84},"Samantha Leigh, BS","CONTACT","5408195715","samantha.m.leigh@dartmouth.edu",{"lat":86,"lon":87},43.64229,-72.25176,[89],{"name":81,"role":82,"phone":83,"email":84},[],[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Mild cognitive disorder",[],{"nct_id":4,"found":45,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an observational study planning to enroll 70 participants. It compares individuals with Mild Cognitive Impairment to cognitively normal individuals.","completed","Observational Study of Speech in Noise for Mild Cognitive Impairment","This study is looking at how people with Mild Cognitive Impairment (MCI) and healthy individuals hear and process sounds, especially in noisy environments. Researchers want to see if there are differences in how well these groups perform on hearing tests and how their brains respond to sound. They are also investigating if these hearing test results are linked to thinking and memory skills in people with MCI. The study aims to enroll 70 participants, aged 55 to 80, who either have MCI or are cognitively normal. The study is observational, meaning there are no interventions or treatments being tested.","Not specified.",99,"You would participate in a Hearing-in-Noise Test (15 minutes), a Triple Digit in Noise Test (15 minutes), and a measurement of auditory neural response in background noise (45 minutes).","Not stated in the trial record.",[],"v2"]