Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea (OSA)

In brief

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 receiving Pillar implants will increase CPAP use

Key facts

Study ID

NCT00730041

Run by

Medtronic Xomed, Inc.

People needed

51

Starts

2007-11-01

Expected to finish

2009-03-01

Last updated by the study team

2010-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Arkansas Center for Sleep Medicine — Little Rock, Arkansas, United States
• Alta Bates Summit Medical Center — Berkeley, California, United States
• Sleep Center at National Jewish Medical Center — Denver, Colorado, United States
• Louisiana Sleep Foundation — Baton Rouge, Louisiana, United States
• Regions Hospital; Health Partners Sleep Health Center — Saint Paul, Minnesota, United States
• NYU Sleep Disorders Center — New York, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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