Abstract
Background Mild obstructive sleep (OSA) is a common disorder associated with daytime sleepiness and impaired quality of life. Given that adherence to positive airway pressure (PAP) therapy in OSA is suboptimal, alternative strategies are needed particularly for patients with mild OSA. Daytime neuromuscular electrical stimulation (NMES) of the tongue is a new therapeutic modality for mild OSA. The objective of this study was to determine if patients with mild OSA adhere to daytime NMES. Methods A randomized sham-controlled double-masked controlled trial was conducted in 40 patients with mild OSA who received either high intensity (active) or low intensity (sham) NMES for 6-weeks. The primary endpoint was adherence to therapy. Exploratory outcomes included the respiratory event index (REI) and the Epworth Sleepiness Scale (ESS) score. Results More than 90% of participants in each arm were adherent to NMES. Exploratory analyses revealed a 32.7% (95% CI: 15.5%, 49.9%) drop in REI with active NMES, with no significant change the REI with sham NMES. Improvements were larger in the supine than non-supine REI. Both the apnea index and hypopnea index improved with active NMES. Finally, the ESS score improved with active but not with sham NMES. Interpretation Daytime NMES was well accepted, with a majority using it for the recommended period. NMES of the tongue use was associated with improvements in OSA severity and daytime sleepiness. Additional research is needed to define its role in the treatment armamentarium across the spectrum of OSA severity and in patients who are intolerant to PAP therapy.