Signifier Medical Technologies reveals positive outcomes in adherence and treatment efficacy for mild obstructive sleep apnea (OSA) with its daytime therapy eXciteOSA, as demonstrated in recent AEGIS clinical trial results soon to be published in ERJ Open Research.

The objective of the trial was to determine whether patients with mild OSA would adhere to eXciteOSA, a daytime neuromuscular electrical stimulation therapy. Results showed high adherence, with approximately 90% of participants in each arm adherent to the therapy. 

“The encouraging results from our first randomized controlled trial further validate the data from our previous studies, and we’re thrilled to see how well patients accept the therapy,” says co-founder and director Akhil Tripathi in a release.

The current standard of care for treating mild OSA, positive airway pressure (PAP), has long been plagued with low adherence and low patient satisfaction. Clinical trials and observational studies indicate that 25-46% of patients are not adherent to PAP. There is also evidence that those with mild OSA are 34% less likely to adhere to PAP than those with moderate/severe OSA. Given that adherence to PAP therapy in OSA is suboptimal, alternative strategies are needed, particularly for patients with mild OSA.

The AEGIS clinical trial was a randomized, double-masked, sham-controlled study to assess the adherence and overall impact of eXciteOSA in managing and treating obstructive sleep apnea. 

Using neuromuscular electrical stimulation therapy to “exercise” the upper airway muscles, eXciteOSA improves tongue muscle endurance and reduces the occurrence of airway collapse during sleep. The trial involved 40 patients and was conducted in collaboration with a network of renowned medical institutions and healthcare professionals.

Key findings of the AEGIS trial include:

  • High adherence: eXciteOSA for 20 minutes a day for six weeks in mild OSA was well accepted, with approximately 90% of the participants adhering to the required days of use.
  • Improvement in OSA severity: eXciteOSA was associated with approximately a 33% improvement in OSA severity after accounting for patient-related factors such as age, sex, race, body mass index, and the time in the supine position. In contrast, OSA severity remained unchanged in participants who received the sham device.
  • Improvement in daytime sleepiness: Participants in the active arm experienced improvements in daytime sleepiness, whereas no such change was noted in the sham arm.

“We are immensely pleased with the positive outcomes observed in the AEGIS clinical trial,” says Naresh Punjabi, MD, the trial’s principal investigator, in a release. “This publication underscores our commitment to advancing healthcare and developing solutions that can make a meaningful difference in the lives of patients.”

Randomized trials are in progress to understand the impact of therapy relative to usual care without treatment (NCT05183009 and NCT05252156) and the impact of therapy amongst those with moderate OSA (NCT05252156).