Obstructive Sleep ApneaNCT07039500
Impact of Severe Obstructive Sleep Apnea-Hypopnea Syndrome on Auditory-Cognitive Processing
An observational study of Obstructive Sleep Apnea and Auditory Processing Disorder, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Auditory Processing Disorder
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2024to 10 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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:
Show all 10Show fewer
- PSG-confirmed severe OSAHS (AHI >30 events/hour)
- Control Group Additional:
- Self-reported absence of snoring/sleep disorders
- No prior OSAHS diagnosis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Caifeng Xia, M.D., +8618811173785, xiacf@pku.edu.cn
About this study
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:
- Does severe OSAHS change how the brain automatically detects sound changes during wakefulness?
- Does severe OSAHS reduce people's ability to pay attention to important sounds when awake?
- Can brainwave tests (Electroencephalogram, EEG) detect early signs of hearing-related cognitive problems in OSAHS patients before symptoms appear?
Read more
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
- Keywords
- Obstructive Sleep Apnea, Auditory Cognition, Electroencephalography (EEG), Oddball Paradigm
- Medical subject headings
- Sleep Apnea, Obstructive, Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of Mismatch Negativity (MMN)
EEG-derived MMN amplitude (microvolts, μV) during oddball task. Lower values indicate impaired automatic sound change detection.
Measured: Day 1
Latency of Mismatch Negativity (MMN)
EEG-derived MMN latency (milliseconds, ms) during oddball task. Longer values indicate slower automatic processing.
Measured: Day 1
Secondary outcomes (3)
Reaction Time in Active Auditory Oddball Task
Time taken to press button after deviant sound onset (milliseconds). Higher values indicate slower processing speed.
Measured: Day 1
Accuracy in Active Auditory Oddball Task
Percentage of correct button presses to deviant sounds (%). Lower values indicate worse performance.
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start11 Dec 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039500
- Sponsor's protocol ID
- PekingUFH-2024RES651-001
- Status last verified
- Dec 2024
- First submitted
- 6 Jun 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Severe Obstructive Sleep Apnea-Hypopnea Syndrome on Auditory-Cognitive Processing
- ClinicalTrials.gov ID
- NCT07039500
- Acronym / sponsor ID
- PekingUFH-2024RES651-001
- Keywords
- Obstructive Sleep Apnea, Auditory Cognition, Electroencephalography (EEG), Oddball Paradigm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does severe OSAHS change how the brain automatically detects sound changes during wakefulness?
- Does severe OSAHS reduce people's ability to pay attention to important sounds when awake?
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (10 listed)
- 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
- PSG-confirmed severe OSAHS (AHI >30 events/hour)
Key exclusion criteria (8 listed)
- History of:
- Chronic steroid use
- Systemic inflammatory diseases or malignancies
- Pregnancy or suspected pregnancy (self-reported)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amplitude of Mismatch Negativity (MMN)
Time frame: Day 1
EEG-derived MMN amplitude (microvolts, μV) during oddball task. Lower values indicate impaired automatic sound change detection.
Latency of Mismatch Negativity (MMN)
Time frame: Day 1
EEG-derived MMN latency (milliseconds, ms) during oddball task. Longer values indicate slower automatic processing.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Auditory Processing Disorder, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caifeng Xia, M.D. (+8618811173785, xiacf@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of Mismatch Negativity (MMN) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.