Obstructive Sleep ApneaPNCDNCT04244162
Postoperative Neurocognitive Disorders
An observational study of Obstructive Sleep Apnea and Neurocognitive Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)) undergoing surgery. The investigators will enroll 50 OSA patients scheduled for surgery. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Neurocognitive Disorders
- What is being tested?
- Brain Imaging, Cognitive testing and Blood Biomarkers
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2020to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index [AHI]>15 events/hour confirmed by overnight polysomnography),
Who may be able to join
- Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index [AHI]>15 events/hour confirmed by overnight polysomnography), scheduled for open or robotic surgery (abdominal, gynecologic, or urologic), and upper or lower extremity orthopedic procedures
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine
Los Angeles, California, 90095
About this study
Official title: Mechanisms Mediating Postoperative Neurocognitive Disorders
The purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)) undergoing surgery. The investigators will enroll 50 OSA patients scheduled for surgery. All patients will have a brain scan (fMRI) within five days before surgery and two days and six months after surgery. During this visit cognitive function will be assessed using the Wide Range Assessment of Memory and Learning (WRAML2) and Montreal Cognitive Assessment (MoCA) tests. Patients will also be asked to participate in a blood draw during the first 2 visits for fMRI (within five days of surgery and two days after surgery). The Confusion Assessment Method (CAM-S) test, will be used to examine postoperative delirium.
Read the detailed description
The investigators will examine the potential mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)). This study proposes that neuro-inflammation is associated with measurable tissue changes that can be examined with MD measures and blood biomarkers.
On the day of surgery, standard of care procedures will take place. Hemodynamic vitals will be continuously monitored. As per the latest guidelines and recommendations from the American Society of Anesthesiologists (ASA), mean arterial pressure (MAP) will be targeted to > 60 mmHg or within 20% of baseline values, and processed EEG-guided anesthesia will be monitored to maintain a patient state index between 20-50. Electronic medical records and intraoperative integrated physiologic waveform will be collected.
In summary, the investigators will examine the potential mechanisms of brain injury contributing to postoperative delirium (POD) and acute and long-lasting neurocognitive deficits in an at-risk population (OSA).
- Conditions
- Obstructive Sleep Apnea, Neurocognitive Disorders
- Being tested
- Brain Imaging, Cognitive testing, Blood Biomarkers
- Keywords
- brain imaging, neurocognitive testing
- Medical subject headings
- Sleep Apnea, Obstructive, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain ImagingDiagnostic test
Magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI)-based mean diffusivity (MD) measures.
Cognitive testingDiagnostic test
Wide Range Assessment of Memory and Learning (WRAML2), Montreal Cognitive Assessment (MoCA), and Confusion Assessment Method for the ICU -severity (CAM-ICU S) tests.
Blood BiomarkersDiagnostic test
Inflammatory markers
| Study group | Role | What they receive |
|---|---|---|
| Study Group | brain scans, cognitive tests, blood biomarkers Receives: Diagnostic Test: Brain Imaging; Diagnostic Test: Cognitive testing; Diagnostic Test: Blood Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative cognitive function
Montreal Cognitive Assessment (MoCA) test
Measured: pre-surgery (within five days before)
Postoperative cognitive dysfunction - delayed cognitive recovery
Montreal Cognitive Assessment (MoCA) test
Measured: Post-surgery (within two days post surgery).
Postoperative cognitive dysfunction - neurocognitive disorder
Montreal Cognitive Assessment (MoCA) test
Measured: Post-surgery (6 months after surgery).
Preoperative cognitive function II
Wide Range Assessment of Memory and Learning (WRAML2)
Measured: pre-surgery (within five days before surgery)
Postoperative cognitive dysfunction - delayed cognitive recovery II
Wide Range Assessment of Memory and Learning (WRAML2)
Measured: Post-surgery (within two days post surgery).
Postoperative cognitive dysfunction - neurocognitive disorder II
Wide Range Assessment of Memory and Learning (WRAML2)
Measured: Post-surgery (6 months after surgery).
Postoperative Delirium
The Confusion Assessment Method (CAM-S) test
Measured: A two times per day for up to three days or discharge from the hospital.
Secondary outcomes (5)
Blood Serum anti-inflammatory Biomarkers
Assess blood inflammatory biomarkers (IL6, TNFa and IL1B) using enzyme-linked immunosorbent assay
Measured: pre- (within five days before surgery)
Blood Serum anti-inflammatory Biomarkers II
Assess blood inflammatory biomarkers (IL6, TNFa and IL1B) using enzyme-linked immunosorbent assay
Measured: post-surgery (within two days of surgery).
Brain changes
Using non-invasive magnetic resonance imaging based diffusion tensor imaging
Measured: pre- (within five days before) and post-surgery (within two days and 6 months).
Brain changes II
Using non-invasive magnetic resonance imaging based diffusion tensor imaging
Measured: Post-surgery (within two days post surgery).
Brain changes III
Using non-invasive magnetic resonance imaging based diffusion tensor imaging
Measured: Post-surgery (within six months post surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start12 Dec 2020
- Primary completion31 Dec 2024
- Study completion31 Aug 2025
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 Massachusetts General 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susana Vacas, MD, PhD, Massachusetts General Hospital
- Investigators
- Rajesh Kumar, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244162
- Sponsor's protocol ID
- PNCD 19-001597
- Acronym
- PNCD
- Status last verified
- Oct 2025
- First submitted
- 23 Jan 2020
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Mediating Postoperative Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT04244162
- Acronym / sponsor ID
- PNCD / PNCD 19-001597
- Conditions
- Obstructive Sleep Apnea, Neurocognitive Disorders
- Keywords
- brain imaging, neurocognitive testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 28 Jan 2020 (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 purpose of this study is to examine the mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)) undergoing surgery. The investigators will enroll 50 OSA patients scheduled for surgery. All patients will have a brain scan (fMRI) within five days before surgery and two days and six months after surgery. During this visit cognitive function will be assessed using the Wide Range Assessment of Memory and Learning (WRAML2) and Montreal Cognitive Assessment (MoCA) tests. Patients will also be asked to participate in a blood draw during the first 2 visits for fMRI (within five days of surgery and two days after surgery). The Confusion Assessment Method (CAM-S) test, will be used to examine postoperative delirium.
Detailed description
The investigators will examine the potential mechanisms of brain injury contributing to postoperative neurocognitive disorders (PNCD) in an at-risk population (obstructive sleep apnea (OSA)). This study proposes that neuro-inflammation is associated with measurable tissue changes that can be examined with MD measures and blood biomarkers.
On the day of surgery, standard of care procedures will take place. Hemodynamic vitals will be continuously monitored. As per the latest guidelines and recommendations from the American Society of Anesthesiologists (ASA), mean arterial pressure (MAP) will be targeted to > 60 mmHg or within 20% of baseline values, and processed EEG-guided anesthesia will be monitored to maintain a patient state index between 20-50. Electronic medical records and intraoperative integrated physiologic waveform will be collected.
In summary, the investigators will examine the potential mechanisms of brain injury contributing to postoperative delirium (POD) and acute and long-lasting neurocognitive deficits in an at-risk population (OSA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Brain Imaging, Diagnostic Test: Cognitive testing, Diagnostic Test: Blood Biomarkersbrain scans, cognitive tests, blood biomarkers |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index [AHI]>15 events/hour confirmed by overnight polysomnography),
Key inclusion criteria (1 listed)
- Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index [AHI]>15 events/hour confirmed by overnight polysomnography), scheduled for open or robotic surgery (abdominal, gynecologic, or urologic), and upper or lower extremity orthopedic procedures
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain ImagingMagnetic resonance imaging (MRI) using diffusion tensor imaging (DTI)-based mean diffusivity (MD) measures. | Diagnostic test | Study Group |
| Cognitive testingWide Range Assessment of Memory and Learning (WRAML2), Montreal Cognitive Assessment (MoCA), and Confusion Assessment Method for the ICU -severity (CAM-ICU S) tests. | Diagnostic test | Study Group |
| Blood BiomarkersInflammatory markers | Diagnostic test | Study Group |
Primary outcome
Preoperative cognitive function
Time frame: pre-surgery (within five days before)
Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - delayed cognitive recovery
Time frame: Post-surgery (within two days post surgery).
Montreal Cognitive Assessment (MoCA) test
Postoperative cognitive dysfunction - neurocognitive disorder
Time frame: Post-surgery (6 months after surgery).
Montreal Cognitive Assessment (MoCA) test
Preoperative cognitive function II
Time frame: pre-surgery (within five days before surgery)
Wide Range Assessment of Memory and Learning (WRAML2)
Postoperative cognitive dysfunction - delayed cognitive recovery II
Time frame: Post-surgery (within two days post surgery).
Wide Range Assessment of Memory and Learning (WRAML2)
Postoperative cognitive dysfunction - neurocognitive disorder II
Time frame: Post-surgery (6 months after surgery).
Wide Range Assessment of Memory and Learning (WRAML2)
Postoperative Delirium
Time frame: A two times per day for up to three days or discharge from the hospital.
The Confusion Assessment Method (CAM-S) test
5 secondary outcomes
Blood Serum anti-inflammatory Biomarkers
Time frame: pre- (within five days before surgery)
Blood Serum anti-inflammatory Biomarkers II
Time frame: post-surgery (within two days of surgery).
Brain changes
Time frame: pre- (within five days before) and post-surgery (within two days and 6 months).
Brain changes II
Time frame: Post-surgery (within two days post surgery).
Brain changes III
Time frame: Post-surgery (within six months post surgery).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rajesh Kumar, PhD principal investigator
University of California, Los Angeles
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 Neurocognitive Disorders, run by Massachusetts General Hospital at 1 site in United States.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 3 Nov 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative cognitive function (time frame: pre-surgery (within five days before)). The study lists 7 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 3 Nov 2025.