Effect of Palatal Implants on Continuous Positive Airway Pressure and Compliance

Abstract

Objective. Determine if the Pillar palatal implant system reduces continuous positive airway pressure (CPAP) pressure and improves patient compliance with CPAP therapy.Study Design. Randomized, double-blind, placebo-controlled study.Setting. Four geographically dispersed tertiary sleep disorder referral centers.Methods. Subjects with mild to moderate sleep apnea dissatisfied with CPAP because of pressure-related complaints were randomized to receive Pillar implants or a sham procedure performed in double-blind fashion. Active and sham groups were compared for changes in therapeutic CPAP pressures (primary outcome) with a 90-day follow-up sleep study and CPAP compliance (secondary outcome) with a 90-day smart card report.Results. Twenty-six subjects were randomized to Pillar implants and 25 to a sham implant procedure. There were no differences between groups with regard to demographics and baseline parameters. Both sham and active groups had reduced mean CPAP pressure (−1.1 vs −0.5 cm H 2 O) with no difference between groups (P = .32) at 90-day follow-up. In addition, there was no difference in average daily CPAP use between groups (P = .80). Both groups experienced improvements in Epworth sleepiness scores and Functional Outcome of Sleep Questionnaire scores at 90 days with no differences between groups. The active group reported significantly higher CPAP satisfaction scores than the sham group (P = .04).Conclusion. Pillar implants do not significantly reduce CPAP pressure or increase CPAP compliance compared to sham controls but may subjectively improve CPAP satisfaction. These findings do not presently support the use of Pillar implants as an adjunctive treatment to improve CPAP compliance.

The Effect of Upper Airway Surgery on Continuous Positive Airway Pressure Levels and Adherence: A Systematic Review and Meta-Analysis

“…Eight studies were excluded due to lack of a comparison of pre- and postoperative CPAPs in patients after UAS. Of the 11 studies that met the inclusion criteria, 5 were retrospective [8,16,17,18,19], 4 were prospective [20,21,22,23], and 2 were RCTs [24,25]. UAS performed in the studies included nasal valve repair, radiofrequency ablation to the palate, turbinate reduction, septoplasty, Pillar implants, tonsillectomy, and UPPP.…”

“…Four studies evaluated CPAP adherence in a control and posttreatment group, or preoperative and postoperative use within the same group [18,21,24,25]. Overall, 80 patients still requiring CPAP after surgery were evaluated after Pillar implants (n = 47), UPPP alone or in combination with a multilevel procedure (n = 16), or inferior turbinate reduction (n = 17).…”

“…Only 3 studies discussed surgical complications [8,20,24]. Out of these, none observed major complications.…”

Blinding in trials of interventional procedures is possible and worthwhile

“…In other trials, a palatal implant delivery system was prepared by the manufacturer to either contain the implant or not, which allowed for blinding of surgeons 17, 18 .…”

Non-positive airway pressure therapy for obstructive sleep apnea

“…But others found no significant change in AHI [169]. A recent study showed that pillar implants may subjectively improve CPAP satisfaction, but failed to show any improvement in the compliance of CPAP or in reduction of CPAP pressure [175]. Therefore, pillar implants cannot be recommended and may only be considered in patients with mild to moderate OSA who cannot tolerate or failed other conservative approaches.…”