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临床试验/NCT07039500
NCT07039500招募中不适用

Impact of Severe Obstructive Sleep Apnea-Hypopnea Syndrome on Auditory-Cognitive Processing

Peking University First Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Amplitude of Mismatch Negativity (MMN)

研究概览

简要总结

The goal of this observational study is to learn how severe obstructive sleep apnea-hypopnea syndrome (OSAHS) affects the brain's ability to process sounds and attention in adults aged 20-60 years. The main questions it aims to answer are:

  1. Does severe OSAHS change how the brain automatically detects sound changes during wakefulness?
  2. Does severe OSAHS reduce people's ability to pay attention to important sounds when awake?
  3. Can brainwave tests (Electroencephalogram, EEG) detect early signs of hearing-related cognitive problems in OSAHS patients before symptoms appear?

Researchers will compare two groups:

  • 50 adults with severe OSAHS (diagnosed by sleep tests)
  • 50 healthy adults matched by age and gender

Participants will:

  • Complete hearing tests (MoCA)

  • Undergo a 1-night sleep test (PSG)

  • Wear an EEG cap for 1.5-2 hours while listening to sounds in a quiet room:

  • Passive task: Relax (no response needed)

  • Active task: Press a button when hearing rare sounds

  • Receive ¥75/hour compensation for their time

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All Participants:
  • Aged 20-60 years
  • Normal hearing (PTA ≤25 dB HL at 0.5,1,2,4 kHz; Type A tympanogram)
  • MoCA score ≥26
  • Willing to complete EEG testing
  • OSAHS Group Additional:
  • PSG-confirmed severe OSAHS (AHI >30 events/hour)
  • Control Group Additional:
  • Self-reported absence of snoring/sleep disorders
  • No prior OSAHS diagnosis

排除标准

  • All Participants:
  • History of:
  • Schizophrenia, epilepsy, Parkinson's, TBI, or language disorders
  • Middle/inner ear diseases (otitis media, acoustic neuroma, etc.)
  • Cognitive impairment or depression/anxiety disorders
  • Chronic steroid use
  • Systemic inflammatory diseases or malignancies
  • Pregnancy or suspected pregnancy (self-reported)

结局指标

主要结局

Amplitude of Mismatch Negativity (MMN)

时间窗: Day 1

EEG-derived MMN amplitude (microvolts, μV) during oddball task. Lower values indicate impaired automatic sound change detection.

Latency of Mismatch Negativity (MMN)

时间窗: Day 1

EEG-derived MMN latency (milliseconds, ms) during oddball task. Longer values indicate slower automatic processing.

次要结局

  • Accuracy in Active Auditory Oddball Task(Day 1)
  • Reaction Time in Active Auditory Oddball Task(Day 1)
  • Inter-Trial Phase Coherence (ITPC) in Theta/Alpha/Beta Bands(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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