Status:
TERMINATED
Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea
Lead Sponsor:
Medtronic Xomed, Inc.
Collaborating Sponsors:
Medtronic
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study will be done for the following purposes: * to see if Pillar implants in combination with CPAP therapy can help people with their OSA by decreasing the CPAP pressures * to find out if receiv...
Detailed Description
Obstructive Sleep Apnea (OSA) is the intermittent cessation of breathing during sleep due to the collapse of the pharyngeal airway. As reported in the April 2004 Journal of the American Medical Associ...
Eligibility Criteria
Inclusion
- OSA documented by sleep study demonstrating AHI \> 10, where hypopneas are defined by Medicare criteria requiring a 4% desaturation
- Adequate CPAP therapy titration (residual AHI \< 5) resulting in a therapeutic pressure ≥7 cm H20 from baseline PSG
- Currently using or willing to change to Respironics CPAP device (without A-flex, C-flex and Bi-flex enabled) with SmartCard technology
- Currently dissatisfied with CPAP therapy
Exclusion
- Uses full face mask
- Soft palate length insufficient to accommodate 18mm implants as measured from the hard palate junction to the base of the uvula (\<25 mm)
- Drug abuse or alcoholism in the year prior to enrollment as assessed by history
- Inconsistent use of sleeping medications (1 or 2 nights per week)
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00730041
Start Date
November 1 2007
End Date
March 1 2009
Last Update
January 12 2010
Active Locations (7)
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1
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, United States, 72205
2
Alta Bates Summit Medical Center
Berkeley, California, United States, 94704
3
Sleep Center at National Jewish Medical Center
Denver, Colorado, United States, 80206
4
Louisiana Sleep Foundation
Baton Rouge, Louisiana, United States, 70809