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

NCT07039500 | Recruiting DMC

• 1 other identifier: PekingUFH-2024RES651-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

Obstructive Sleep Apnea; Auditory Cognition; Electroencephalography (EEG); Oddball Paradigm

Outcome Measures

Primary Outcomes (2)

• Amplitude of Mismatch Negativity (MMN)

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

  Day 1

• Latency of Mismatch Negativity (MMN)

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

  Day 1

Secondary Outcomes (3)

• Reaction Time in Active Auditory Oddball Task

  Day 1

• Accuracy in Active Auditory Oddball Task

  Day 1

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

  Day 1

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Two distinct populations: 1. Severe OSAHS Patients: * Recruited from otolaryngology clinics at Peking University First Hospital * Diagnosed via in-lab PSG (AHI\>30) 2. Healthy Controls: * Community volunteers from Beijing area * Age/sex-matched to OSAHS group

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Auditory Perceptual Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Auditory Diseases, Central; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Brain Diseases; Central Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Caifeng Xia, M.D.

CONTACT

+8618811173785; xiacf@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 26, 2025
• Study Start: December 11, 2024
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: August 7, 2025

Record last verified: 2024-12

Locations

CN (1)