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NCT02325687 · ClinicalTrials.gov registry record · NA
A Pilot Study of Biomarkers in Obstructive Sleep Apnea
A NA study of Obstructive Sleep Apnea, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT02325687: Completed NA study of Obstructive Sleep Apnea, sponsored by Hospital for Special Surgery, New York.
NCT02325687 is a NA study of Obstructive Sleep Apnea that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 50 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02325687, a NA study of Obstructive Sleep Apnea, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary outcome, the levels of cytokine IL-6 in serum of OSA-treated, OSA-untreated and control patients presenting for knee replacement surgery with planned spinal or combined spinal-epidural anesthesia.
Conditions Studied
Interventions
- PROCEDURE Lumbar Puncture (Standard-of-Care)
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-11 |
| Phase | NA |
What the finished NCT02325687 record still lists
NCT02325687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 1 intervention - of which Lumbar Puncture (Standard-of-Care) is the first listed.
NCT02325687 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02325687 about?
NCT02325687 is a clinical study titled "A Pilot Study of Biomarkers in Obstructive Sleep Apnea". 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 hav...
What is the current status of trial NCT02325687?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2015-01. Estimated completion is 2016-11.
What conditions does trial NCT02325687 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea.
What interventions are being tested in trial NCT02325687?
The interventions under investigation include: Lumbar Puncture (Standard-of-Care) (PROCEDURE).
Who is sponsoring clinical trial NCT02325687?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02325687 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02325687's enrollment target sits among peer trials
50 103rd of 155 higher than 49 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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