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临床试验/NCT06102486
NCT06102486
招募中
不适用

Speech Perception in Noise as an Improved Marker for Neurocognitive Dysfunction

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 70 人2024年5月18日

概览

阶段
不适用
干预措施
MCI
疾病 / 适应症
Mild Cognitive Impairment
发起方
Dartmouth-Hitchcock Medical Center
入组人数
70
试验地点
2
主要终点
Hearing-in-Noise Test Performance
状态
招募中
最后更新
3个月前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2024年5月18日
结束日期
2026年5月2日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Christopher E. Niemczak

Research Scientist

Dartmouth-Hitchcock Medical Center

入排标准

入选标准

  • 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 (\<40 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

排除标准

  • 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/caffeine)

研究组 & 干预措施

MCI

Participants diagnosed with or suspected to have MCI

Control

Participants without MCI

结局指标

主要结局

Hearing-in-Noise Test Performance

时间窗: 1 time point (takes 15 minutes)

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.

Size of auditory neural response in background noise

时间窗: 1 time point (takes 45 minutes)

The change in amplitude of neural response between energetic masking and 2-talker informational masking (IM).

Triple Digit in Noise Test Performance

时间窗: 1 time point (takes 15 minutes)

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.

Timing of auditory neural response in background noise

时间窗: 1 time point (takes 45 minutes)

The change in latency of neural response between energetic masking and 2-talker informational masking (IM).

研究点 (2)

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