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Recruiting NCT07039500

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

Observational Obstructive Sleep Apnea Auditory Processing Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Auditory Processing Disorder. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

  • Amplitude of Mismatch Negativity (MMN) [Time frame: Day 1]
  • Latency of Mismatch Negativity (MMN) [Time frame: Day 1]
Secondary outcome measures (3)
  • Reaction Time in Active Auditory Oddball Task [Time frame: Day 1]
  • Accuracy in Active Auditory Oddball Task [Time frame: Day 1]
  • Inter-Trial Phase Coherence (ITPC) in Theta/Alpha/Beta Bands [Time frame: Day 1]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Peking University First Hospital — Beijing

Identifiers

NCT: NCT07039500 · PekingUFH-2024RES651-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗