Novel Mouthguard Device Significantly Reduces Nightly Sleep Apnea Events


An alternative device to CPAP shows clinical benefit and long-term patient adherence in new SLEEP 2024 trial data.

Novel Mouthguard Device Significantly Reduces Nightly Sleep Apnea Events

Kent Smith, DDS, D-ABDSM

Credit: LinkedIn

A novel oral appliance therapy may provide a precise and unique clinical benefit for the management of obstructive sleep apnea (OSA), according to findings from a late-breaking abstract presented at SLEEP 2024.

Findings from a multicenter retrospective trial support the efficacy and safety of a precision oral appliance therapy made from US Pharmacopoeia (USP) Class VI plastic material that is marketed as a convenient alternative to standard-care continuous positive airway pressure (CPAP) machines, in the treatment of patients with OSA.

As advertised by Michigan-based practice Funktional Sleep, the alternative oral appliance therapy was designed to promote comfort, portable convenience and limited sleep-related irritation while providing similar efficacy to that of CPAP therapy.

“Sleep apnea often responds to oral appliance therapy, which prevents the conditions that cause airway blockage by holding the tongue or jaw in a forward position, keeping the soft tissues at the back of the throat out of the vicinity of the airway,” the company’s website states. “The appliance feels similar to a mouthguard and is quite comfortable, which is why many patients prefer this treatment method over a CPAP mask that forces air into the airway to keep it open.”

A team of investigators, led by Kent Smith, DDS, D-ABDSM, founding practitioner and chief medical officer of Sleep Dallas, sought to evaluate the clinical effect of the novel oral appliance therapy for the treatment of OSA. The assessment included a single-arm, chart-based cohort of 91 patients diagnosed with OSA from multiple care centers.

Smith and colleagues sought a trio of outcomes relating to treatment efficacy and patient adherence:

  • Reduction of OSA events to <10 per hour, per apnea hypopnea index (AHI).
  • Reduction of OSA events to <20 per hour per AHI and overall 50% improvement in disease severity among patients with severe OSA.
  • Rate of treatment discontinuation at ≥1-year follow-up, or rate of discontinuation due to materials-related adverse events at 1 year.

Investigators observed that approximately 9 in every 10 patients (89%) with any severity of OSA achieved the primary outcome of reduced OSA events to <10 per hour at the studyy’s end; that rate was even greater among patients with mild to moderate disease (98%).

Another 80% of patients with severe OSA, without screening or excluding participants for airway collapse profile, achieved the secondary efficacy endpoint of <20 OSA events per hour plus ≥50% improvement per AHI.

The oral appliance therapy was well-tolerated by trial participants; at a minimum 1-year follow-up, 96% of all patients confirmed to be in active treatment still, and no patients reported discontinuation due to adverse events related to the novel therapy.

Smith and colleagues’ findings support the prospect of a mouth guard-inspired alternative to CPAP in the management of sleep apnea.

“This novel, precision oral appliance therapy medical device made from USP Class VI qualified material demonstrated efficacy and safety for the treatment of patients with OSA,” the team concluded.


  1. Smith K, Carollo J, Desai A, Murphy MT. Evaluating the Clinical Performance of a Novel, Precision Oral Appliance Therapy Medical Device Made Wholly from a Medical Grade Class VI Material for the Treatment of Obstructive Sleep Apnea. Paper presented at: Associated Professional Sleep Societies (SLEEP) 2024 Annual Meeting. Houston, TX. June 1 – 5, 2024.
  2. Funktional Sleep. Oral Appliance Therapy. Web page. Accessed May 30, 2024.
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