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NCT01578031 · ClinicalTrials.gov registry record · NA

The Effects of Treating Obese and Lean Patients With Sleep Apnea

A NA study, sponsored by University of Pennsylvania.

Completed
Registry status
NA
Development phase
450
Enrollment target

NCT01578031: Completed NA study, sponsored by University of Pennsylvania.

NCT01578031 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 450 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01578031, a NA study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
NA
Development phase
450 participants
Enrollment target

Study Summary

The investigators' overall goal is to compare the effect of CPAP treatment on intermediate cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative data from non-OSA subjects with comparable amounts of visceral adiposity, the two OSA groups will have comparable improvements in daytime sleepiness, but that the cardiovascular and metabolic improvements following CPAP therapy will be decreased in OSA patients with increased visceral adipose tissue. The investigators anticipate that, although there will be a greater absolute change in markers of sympathetic activity, inflammation and oxidative stress in obese compared to lean OSA patients following CPAP treatment, the levels will still be abnormally high in the obese patients resulting in the decreased improvements in insulin resistance, arterial blood pressure, and vascular health in obese versus lean OSA patients.

Interventions

  • OTHER Usual Care
  • DEVICE Positive Airway Pressure During Sleep (ResMed S9 Elite)

Trial Details

FieldValue
Enrollment Target 450 participants
Start Date 2009-03
Est. Completion 2014-09
Phase NA

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT01578031

The ClinicalTrials.gov registry entry for NCT01578031 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.

NCT01578031 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01578031 about?

NCT01578031 is a clinical study titled "The Effects of Treating Obese and Lean Patients With Sleep Apnea". The investigators' overall goal is to compare the effect of CPAP treatment on intermediate cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative data from non-OSA subjects with...

What is the current status of trial NCT01578031?

This trial is currently completed. It is a NA study. The enrollment target is 450 participants. The study started on 2009-03. Estimated completion is 2014-09.

What interventions are being tested in trial NCT01578031?

The interventions under investigation include: Usual Care (OTHER), Positive Airway Pressure During Sleep (ResMed S9 Elite) (DEVICE).

Who is sponsoring clinical trial NCT01578031?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.