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| Sponsor: | St. Luke's Hospital, Chesterfield, Missouri |
|---|---|
| Collaborator: |
Ventus Medical, Inc. |
| Information provided by: | St. Luke's Hospital, Chesterfield, Missouri |
| ClinicalTrials.gov Identifier: | NCT00901771 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Sleep Apnea, Obstructive |
Device: Provent |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Non-randomized, Case Series Study of the Effectiveness of Provent Treatment of Obstructive Sleep Apnea Patients Who Are Non-compliant or Minimally Adherent With Positive Airway Pressure Therapy |
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2009 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |
| Sleep Medicine and Research Center at St. Luke's Hospital | |
| Chesterfield, Missouri, United States, 63017 | |
| Principal Investigator: | James K Walsh, Ph.D. | Sleep Medicine and Research Center at St. Luke's Hospital |
More Information
| Responsible Party: | James K. Walsh, Ph.D., Sleep Medicine and Research Center at St. Luke's Hospital |
| ClinicalTrials.gov Identifier: | NCT00901771 History of Changes |
| Other Study ID Numbers: | Ventus C020 |
| Study First Received: | May 13, 2009 |
| Last Updated: | June 14, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Sleep Sleep Apnea, Obstructive OSA OSAH |
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |