Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Pillar Palatal Implant System; Sham system
Intervention description: 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.; 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: obstructive sleep apnea; continuous positive air pressure

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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)