RecruitingNot Applicable

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

China100 participantsStarted 2024-12-11

Plain-language summary

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

Who can participate

Age range

20 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Amplitude of Mismatch Negativity (MMN)

Timeframe: Day 1

Latency of Mismatch Negativity (MMN)

Timeframe: Day 1

Trial details

NCT IDNCT07039500

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-10

Contact for this trial

Caifeng Xia, M.D.

+8618811173785 xiacf@pku.edu.cn

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials