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

NCT00730041 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2010-01-12

Study results available
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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 receiving Pillar implants will increase CPAP use

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

DEVICE

Pillar Palatal Implant System

The Pillar system is intended as an initial treatment option for mild to moderate OSA. It consists of a delivery system and an implant. The delivery system is comprised of a disposable handle and needle assembly that allows for positioning and placement of the implant within the soft palate of the mouth. The 18mm x 2mm implant is a cylindrical shaped segment of braided polyester filaments that is intended for permanent implantation into the soft palate. The implant is pre-loaded into the needle. Three implants are placed in each subject under local anesthesia. Because implants are not able to be seen in the soft palate tissue, the physician is unable to see if an implant is placed or not placed and thus is blinded to the intervention type.

DEVICE

Sham system

The Pillar system consists of a delivery system and an implant. The only difference between the treatment and sham arm in this study is that the sham delivery device is not pre-loaded with the implant. Otherwise the appearance, manufacturing and function of the delivery devices are identical. Three insertions are made, but no implants are actually deployed during the procedure. Because implants are not able to be seen in the soft palate tissue, the physician is unable to see if an implant is placed or not placed and thus is blinded to the intervention type.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Xomed, Inc.

    lead INDUSTRY

Principal Investigators

  • David M Rapoport, MD · NYU Sleep Disorders Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-09-30
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00730041 on ClinicalTrials.gov