NCT00901771

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: St. Luke's Hospital, Chesterfield, Missouri · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2009-05-14
• Last updated: 2010-06-15

Locations

1 site across 1 country: United States