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Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP

NCT00901771 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-06-15

No results posted yet for this study

Summary

The primary objective of the proposed investigation is to evaluate the efficacy of the Provent device in a sample of OSA patients who have either refused or been non-adherent with PAP treatment. Both initial efficacy (evaluated after approximately one week with Provent) and efficacy after approximately 5 weeks in patients who demonstrate initial efficacy will be assessed. A secondary objective is to assess adherence with Provent treatment during the 5-week evaluation period.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

Provent

This is a non-randomized, single-arm, case series study. All subjects will receive Provent device.

Sponsors & Collaborators

  • Ventus Medical, Inc.

    collaborator INDUSTRY

  • St. Luke's Hospital, Chesterfield, Missouri

    lead OTHER

Principal Investigators

  • James K Walsh, Ph.D. · Sleep Medicine and Research Center at St. Luke's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2009-10-31
Completion
2009-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901771 on ClinicalTrials.gov