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COMPLETED Phase 1

Sleep Apnea Treatment With Expiratory Resistance(Provent™)

NCT01061476 · View on ClinicalTrials.gov ↗

Study Summary

Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the current study is to examine how well the Provent™ device treats OSA with particular attention to the how the it may treat sleep apnea and who may most likely benefit from the use of this treatment.

Conditions Studied

Interventions

  • DEVICE Treatment sleep study (Provent™ device used)
  • OTHER Baseline sleep study (No device)
  • OTHER Physiology sleep study (Provent™ on/off)

Study Locations (1)

Maryland

  • Johns Hopkins Asthma and Allergy Center — Baltimore

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2010-01
Est. Completion 2011-01
Phase Phase 1

Sponsor

Johns Hopkins University

1,517 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01061476

The ClinicalTrials.gov registry entry for NCT01061476 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,517 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 3 interventions — of which Treatment sleep study (Provent™ device used) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01061476 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01061476 about?

NCT01061476 is a clinical study titled "Sleep Apnea Treatment With Expiratory Resistance(Provent™)". Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been dev...

What is the current status of trial NCT01061476?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2010-01. Estimated completion is 2011-01.

What conditions does trial NCT01061476 study?

This clinical trial studies the following conditions: Sleep Apnea, Obstructive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01061476?

The interventions under investigation include: Treatment sleep study (Provent™ device used) (DEVICE), Baseline sleep study (No device) (OTHER), Physiology sleep study (Provent™ on/off) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01061476?

This trial is sponsored by Johns Hopkins University, which has 1,517 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01061476 being conducted?

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

Related

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