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

P

Peking University

Status

Enrolling

Conditions

Auditory Processing Disorder
Obstructive Sleep Apnea

Study type

Observational

Funder types

Other

Identifiers

NCT07039500
PekingUFH-2024RES651-001

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

100 participants in 2 patient groups

Severe OSAHS Group
Description:
Adults aged 20-60 years with severe obstructive sleep apnea-hypopnea syndrome (AHI\>30 events/hour) confirmed by polysomnography (PSG). Participants undergo PSG, hearing tests (pure-tone audiometry, tympanometry), Montreal Cognitive Assessment (MoCA), and EEG recording during active/passive auditory oddball tasks measuring MMN, P300, and behavioral responses.
Healthy Control Group
Description:
Age/sex-matched healthy adults (20-60 years) with self-reported absence of snoring/sleep disorders. Participants complete hearing tests (pure-tone audiometry, tympanometry), Montreal Cognitive Assessment (MoCA), and EEG recording during identical auditory oddball tasks as the OSAHS group.

Trial contacts and locations

1

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Central trial contact

Caifeng Xia, M.D.

Data sourced from clinicaltrials.gov

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