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

NCT ID: NCT07039500

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-11
• Study Completion Date: 2025-12-10

Brief 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

Conditions

Obstructive Sleep Apnea; Auditory Processing Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Severe OSAHS Group

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.

No interventions assigned to this group

Healthy Control Group

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.

No interventions assigned to this group

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Caifeng Xia, M.D.

Role: CONTACT

xiacf@pku.edu.cn

+8618811173785

Facility Contacts

Caifeng Xia, M.D.

Role: primary

xiacf@pku.edu.cn

+8618811173785

Other Identifiers

PekingUFH-2024RES651-001

Identifier Type: -

Identifier Source: org_study_id