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NCT00653471 · ClinicalTrials.gov registry record · Early Phase 1

Micro-stream Capnography in Non-intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea

A Early Phase 1 study of Obesity and Obstructive Sleep Apnea, sponsored by The Cleveland Clinic.

Completed
Registry status
Early Phase 1
Development phase
60
Enrollment target
1
Study location

NCT00653471 is a Early Phase 1 study of Obesity and Obstructive Sleep Apnea that has completed, run by The Cleveland Clinic. The registered enrollment target is 60 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00653471, a Early Phase 1 study of Obesity and Obstructive Sleep Apnea, has completed, sponsored by The Cleveland Clinic.

COMPLETED
Registry status
Early Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to compare the accuracy of EtPCO2 measurements taken with a nasal cannula using the Microcap (Oridion Capnography Inc., Needham, MA) micro-stream device and the TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). Three groups of non-intubated, spontaneously breathing patients will be included: 1) lean patients without obstructive sleep apnea (OSA); 2) obese patients without OSA; and 3) obese patients diagnosed with OSA. This latter group has a higher prevalence of oral breathing. Additionally, to test the efficacy of oral guides, we propose to compare the accuracy of EtPCO2 measurements from the Microcap with two different nasal cannulas, one with (Smart CapnoLine PlusTM, Oridion Medical, Jerusalem, Israel) and one without (CapnoLineTM H, Oridion Medical) an oral guide to trap gas expired from the mouth. The TG-920 main-stream system requires its purpose-designed YG-122T cannula so that is the only one that will be tested with the Nihon-Kohden product.

Conditions Studied

Obesity Obstructive Sleep Apnea

Interventions

  • DEVICE Microcapmicro-stream device with Smart CapnoLine Plus
  • DEVICE Microcap micro-stream device with CapnoLine
  • DEVICE TG-920 main-stream device (Nihon Kohden, Tokyo, Japan).

Study Locations (1)

Kentucky

  • University of Louisville - Louisville

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2006-06
Est. Completion 2008-09
Phase Early Phase 1

Sponsor

The Cleveland Clinic

688 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00653471

The ClinicalTrials.gov registry entry for NCT00653471 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which Microcapmicro-stream device with Smart CapnoLine Plus is the first listed.

NCT00653471 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT00653471 about?

NCT00653471 is a clinical study titled "Micro-stream Capnography in Non-intubated Lean and Obese Patients With and Without Obstructive Sleep Apnea". The purpose of this study is to compare the accuracy of EtPCO2 measurements taken with a nasal cannula using the Microcap (Oridion Capnography Inc., Needham, MA) micro-stream device and the TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). Three groups of non-intubated, spontaneously breathing...

What is the current status of trial NCT00653471?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2006-06. Estimated completion is 2008-09.

What conditions does trial NCT00653471 study?

This clinical trial studies the following conditions: Obesity, Obstructive Sleep Apnea.

What interventions are being tested in trial NCT00653471?

The interventions under investigation include: Microcapmicro-stream device with Smart CapnoLine Plus (DEVICE), Microcap micro-stream device with CapnoLine (DEVICE), TG-920 main-stream device (Nihon Kohden, Tokyo, Japan). (DEVICE).

Who is sponsoring clinical trial NCT00653471?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00653471 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.