Interim results from a five-year real world observational study of an oral appliance to treat OSA found that more than 90% of users reported wearing the appliance all night at 12 months. All users had moderate to severe OSA, and more than half achieved at least a 50% reduction in apnea-hypopnea index (AHI). Patient reported outcomes on the Epworth Sleepiness Scale (ESS), the-Pichot Fatigue Scale, and subjective snoring all demonstrated improvements.1
“CPAP works better than oral appliances to reduce AHI, but people don’t use CPAP as routinely as they use a well-fitting oral appliance,” said sleep consultant Robyn Woidtke, MSN, RN, RSPGT. “Data coming out of this and other studies demonstrates that oral appliance therapy, even in severe patients, can improve in OSA treatment. We are seeing that oral appliance therapy can be as effective in mean disease alleviation as CPAP. That’s an important advantage for people who can’t or don’t use CPAP.”
Woidtke presented interim results from a multicenter French trial of the Panthera D-SAD at World Sleep 2025—the World Sleep Society’s annual conference—in September. She is a consultant for Panthera Sleep.
The D-SAD is a patient-matched 3D-printed oral appliance manufactured for each patient’s individual dentition and oral anatomy. Oral appliances act as mechanical splints to bring the lower mandible forward, stabilizing the tongue and increasing the lateral aspects of the upper airway to improve air flow and sleep-disordered breathing.
The trial enrolled 253 individuals across 15 sleep centers in France. Just over half (51%) were male, the mean age of participants was 49.7 years, body mass index was 26.75, and baseline AHI was 22.2. At baseline, 86.6% of participants had moderate OSA, with AHI scores of 15 to 30, and 13.4% had severe OSA with AHI ≥30. Prior CPAP use was 24%.
French health regulations indicate oral therapy for individuals with moderate to severe OSA, Woidtke noted. By contrast, the US Food and Drug Administration’s indication for oral therapy is limited to those with mild to moderate OSA. The American Academy of Sleep Medicine supports using oral appliance therapy where appropriate, even in severe cases.
Oral appliance therapy is an interdisciplinary approach between a medical sleep specialist who evaluates and diagnoses the patient and prescribes OSA therapy and a dental sleep specialist who fits the appliance. The D-SAD uses digital imaging with computer-aided design and manufacturing to create a 3D-printed appliance. Finished appliances are shipped to dental sleep practitioners, who ensure the devices fit and that patients are comfortable wearing them.
The majority of participants (84.3%) reported a satisfactory fit at their initial visits. Most participants with moderate OSA (87.8%) and severe OSA (83.4%) transitioned to a lower AHI classification on sleep testing. More than half (57.5%) had a resultant AHI <10, and 20.8% had an AHI <5. Overall, 60.3% of participants had ≥50% reduction in AHI. Outcomes data in this population did not show any gender or BMI differences in responders.
At month 12, participants used their appliances a mean of 6.2 nights per week and >92% used them ≥4 hours per night for ≥4 nights per week. Use fell slightly from 6.6 nights per week at three months to 6.4 nights at six months and 6.2 nights at 12 months. During the routine annual call, 94.7% of participants reported wearing their device all night. Satisfaction with use was 82.8% at three months and 91.9% at 12 months.
“OSA is not just a diagnostic burden, it’s a therapeutic burden based on whether individuals can integrate treatment into their lives,” Woidtke said. “Access to CPAP is an issue for some people and not everyone tolerates CPAP. There are also social determinants of health to consider. Not everyone has access to electricity where they sleep, and some may have to move from place to place because of their housing situations. When people are evaluated for sleep-disordered breathing, all the options should be given to them with shared decision-making based on their individual needs and living circumstances.”
References
1. Gagnadoux F, Fortin M, Woidtke R, et al. Five-year, prospective, multicenter, real-world study to assess initial delivery, management and long-term effectiveness of a CAD/CAM, 3-D printed oral appliance in the treatment of obstructive sleep apnea: interim analysis update. Paper presented at: World Sleep 2025; September 8, 2025; Singapore.
