N/A
Completed N=50
A Pilot Study of Biomarkers in Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT02325687 ↗Enrolled (actual)
50
Serious AEs
—
Results posted
Apr 2020
Primary outcomePrimary: Serum IL-6 (Interleukin 6) Levels — NA; NA; NA pg/mL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum IL-6 (Interleukin 6) Levels |
NA; NA; NA | — |
| SECONDARY Serum and CSF (Cerebrospinal Fluid) Levels of the Cytokines TNF-alpha (Tumor Necrosis Factor) , IL-6, IL-8, IL-10 (Interleukin) |
— | — |
| SECONDARY Serum and CSF Levels of the Neurotrophins BDNF, IFN-gamma (Interferon Gamma) |
— | — |
| SECONDARY Number of Participants With Respiratory, Cardiac, and/or CNS (Central Nervous System) Complications |
2; 5; 0; 4; 4; 0 | — |
| SECONDARY Incidence of Intraoperative Obstructive Respiratory Events |
8; 9; 0; 2; 1; 2 | — |
| SECONDARY Levels of Blood Oxygen Saturation |
— | — |
| SECONDARY Length of Stay in the Recovery Unit |
— | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02325687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.