Expired Study
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New York, New York 10021


Purpose:

Obstructive sleep apnea (OSA) is common and is a risk factor for postoperative complications, including respiratory and cardiac events and delirium. Despite this risk, however, there are currently no accepted biomarkers that can predict poor outcomes, making it unclear to see which patients will have complications after surgery, and who might need prolonged monitoring or an extended hospital stay. An improved understanding of the pathophysiology of OSA is required to identify potential biomarkers for outcomes after surgery, as well as to develop new treatments. The aim of this pilot study is to identify serum and cerebrospinal (CSF) biomarkers associated with obstructive sleep apnea (OSA). The presence of cytokines and neurotrophins will be determined and quantified in both patients with OSA and in controls. The CSF samples will additionally be analyzed by proteomic methods to identify potential biomarkers with significantly different levels present in patients with and without OSA. The working hypothesis is that OSA patients who are non-CPAP-compliant will have higher levels of circulating cytokines and lower levels of circulating neurotrophins in serum and CSF, compared to patients who are CPAP-compliant and/or controls.


Criteria:

Inclusion Criteria: - Patients between the ages of 50 and 84 - Treated and Untreated OSA Patients: Known OSA, diagnosed by polysomnography - Treated OSA Patients: Known CPAP prescription, dose used nightly, and compliance status - Controls: No suspicion for OSA, based on STOP-BANG screening score (<3) - Any patient presenting for knee replacement surgery with prior consent for spinal or combined spinal-epidural anesthesia Exclusion Criteria: - Presence of dementia - Presence of cognitive disease - Presence of depression, anxiety, or other mood disorder(s) - Recent oral steroid therapy (within prior 6 months) - Requirement of stress-dose steroids pre-operatively - Autoimmune disease - Neurologic disease - Controls: Suspected OSA, either disclosed by patient, or by clinical suspicion based on STOP-BANG questionnaire (score ≥ 3) - Chronic renal disease - Chronic liver disease - Traumatic spinal or spinal-epidural placement (i.e., blood-contaminated CSF) - Alcohol abuse - defined as being diagnosed with alcohol abuse or consuming more than 2 drinks per night, on average - Use of NSAIDs within 7 days prior to surgery - Chronic benzodiazepine use (for more than one month)


NCT ID:

NCT02325687


Primary Contact:

Principal Investigator
Kethy M Jules-Elysee, MD
Hospital for Special Surgery, New York


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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