Postoperative Neurocognitive Disorders

NCT04244162 | Completed

• 1 other identifier: PNCD 19-001597
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obstructive Sleep Apnea; Neurocognitive Disorders

Keywords

brain imaging; neurocognitive testing

Outcome Measures

Primary Outcomes (7)

• Preoperative cognitive function

  Montreal Cognitive Assessment (MoCA) test

  pre-surgery (within five days before)

• Postoperative cognitive dysfunction - delayed cognitive recovery

  Montreal Cognitive Assessment (MoCA) test

  Post-surgery (within two days post surgery).

• Postoperative cognitive dysfunction - neurocognitive disorder

  Montreal Cognitive Assessment (MoCA) test

  Post-surgery (6 months after surgery).

• Preoperative cognitive function II

  Wide Range Assessment of Memory and Learning (WRAML2)

  pre-surgery (within five days before surgery)

• Postoperative cognitive dysfunction - delayed cognitive recovery II

  Wide Range Assessment of Memory and Learning (WRAML2)

  Post-surgery (within two days post surgery).

• Postoperative cognitive dysfunction - neurocognitive disorder II

  Wide Range Assessment of Memory and Learning (WRAML2)

  Post-surgery (6 months after surgery).

• Postoperative Delirium

  The Confusion Assessment Method (CAM-S) test

  A two times per day for up to three days or discharge from the hospital.

Secondary Outcomes (5)

• Blood Serum anti-inflammatory Biomarkers

  pre- (within five days before surgery)

• Blood Serum anti-inflammatory Biomarkers II

  post-surgery (within two days of surgery).

• Brain changes

  pre- (within five days before) and post-surgery (within two days and 6 months).

• Brain changes II

  Post-surgery (within two days post surgery).

• Brain changes III

  Post-surgery (within six months post surgery).

Study Arms (1)

Study Group

brain scans, cognitive tests, blood biomarkers

Diagnostic Test: Brain Imaging; Diagnostic Test: Cognitive testing; Diagnostic Test: Blood Biomarkers

Interventions

Brain Imaging DIAGNOSTIC_TEST

Magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI)-based mean diffusivity (MD) measures.

Study Group

Cognitive testing DIAGNOSTIC_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.

Study Group

Blood Biomarkers DIAGNOSTIC_TEST

Inflammatory markers

Study Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a diagnosis of moderate-to-severe OSA (apnea hypopnea index \[AHI\]\>15 events/hour confirmed by overnight polysomnography),

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Neurocognitive Disorders

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Rajesh Kumar, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 28, 2020
• Study Start: December 12, 2020
• Primary Completion: December 31, 2024
• Study Completion: August 31, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)