Initial U.S. pilot study: palatal implants for the treatment of snoring.

OBJECTIVE

To assess efficacy of polyethylene terephthalate (PET) implants in the soft palate for the treatment of socially significant snoring.

DESIGN

A prospective, interventional case series.

SETTING

Hospital-based multi-specialty clinic.

PATIENTS: Twenty-five consecutive patients with socially significant snoring without history of obstructive sleep apnea.

INTERVENTION: Three PET implants were inserted into the soft palate of each patient (Pillar procedure, Restore Medical, Inc., St. Paul, Minnesota).

MAIN OUTCOME MEASURE: Change in snoring severity measured by the bed partner using a 10-centimeter visual analog scale (VAS) where 0 = "no snoring noise" and 10 = "extreme snoring noise causing (the bed partner) to leave the bedroom."

RESULTS

Ninety-day follow-up data was collected for 21 patients. Four patients had incomplete follow-up. Snoring VAS rated by the bed partner had a baseline mean value of 8.5 +/- 1.4, which decreased to 5.0 +/- 2.1 at 30 days and to 4.4 +/- 2.5 at 90 days (P < 0.001). All patients tolerated the procedure well and no procedure-related complications were observed. Two implants partially extruded in 1 patient within the 90-day follow-up period, for an implant partial extrusion rate of 2.7% (2/75 implants) and patient partial extrusion rate of 4% (1/25 patients). At 90 days, 75% of patients and 90% of their bed partners recommended the procedure.

CONCLUSIONS

In this case series, PET implants into the soft palate significantly reduced snoring with few extrusions and no complications. Controlled studies are needed to confirm effectiveness and to refine patient selection criteria.

EBM RATING: C-4.