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NCT Number: NCT07039500

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

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

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

Primary outcomes

  1. Amplitude of Mismatch Negativity (MMN)

    Time frame: Day 1

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

  2. Latency of Mismatch Negativity (MMN)

    Time frame: Day 1

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

Secondary outcomes

  1. Reaction Time in Active Auditory Oddball Task

    Time frame: Day 1

    Time taken to press button after deviant sound onset (milliseconds). Higher values indicate slower processing speed.

  2. Accuracy in Active Auditory Oddball Task

    Time frame: Day 1

    Percentage of correct button presses to deviant sounds (%). Lower values indicate worse performance.

  3. Inter-Trial Phase Coherence (ITPC) in Theta/Alpha/Beta Bands

    Time frame: Day 1

    EEG oscillatory synchronization (range 0-1; 0=no phase consistency). Lower values indicate neural desynchronization during auditory processing.

Study contacts

Contact information is provided by the study sponsor or research team.

Caifeng Xia, M.D.

CONTACT

[email protected]

+8618811173785

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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