ClinicalTrials.gg
RecruitingNCT07039500Updated Aug 7, 2025

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

An observational study in Obstructive Sleep Apnea and Auditory Processing Disorder, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Peking University First Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Ages
20 Years to 60 Years
Sex
All
01

Study 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
02

Conditions studied

  • Obstructive Sleep Apnea
  • Auditory Processing Disorder

Keywords

  • Obstructive Sleep Apnea
  • Auditory Cognition
  • Electroencephalography (EEG)
  • Oddball Paradigm
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 100 is close to the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All Participants:

  • Aged 20-60 years
  • Normal hearing (PTA ≤25 dB HL at 0.5,1,2,4 kHz; Type A tympanogram)
  • 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

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 use
  • Systemic inflammatory diseases or
  • Pregnancy or suspected pregnancy (self-reported)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Amplitude of Mismatch Negativity (MMN)

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

    Time frame: Day 1

  2. Latency of Mismatch Negativity (MMN)

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

    Time frame: Day 1

Secondary outcomes

  1. Reaction Time in Active Auditory Oddball Task

    Time taken to press button after deviant sound onset (milliseconds). Higher values indicate slower processing speed.

    Time frame: Day 1

  2. Accuracy in Active Auditory Oddball Task

    Percentage of correct button presses to deviant sounds (%). Lower values indicate worse performance.

    Time frame: Day 1

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

    EEG oscillatory synchronization (range 0-1; 0=no phase consistency). Lower values indicate neural desynchronization during auditory processing.

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2024 (actual). Primary completion is estimated for Dec 2025, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2025
First posted
Jun 26, 2025
StartActual
Dec 11, 2024
Primary completionEst.
Dec 10, 2025
CompletionEst.
Dec 10, 2025
Last update
Aug 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07039500
Responsible party
Sponsor
First posted
Jun 26, 2025
Start date
Dec 11, 2024
Primary completion
Dec 10, 2025 (estimated)
Completion
Dec 10, 2025 (estimated)
Last update
Aug 7, 2025

Study contacts

Caifeng Xia, M.D.
Contact
xiacf@pku.edu.cn
+8618811173785

Oversight

Data monitoring committee
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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