Signifier Medical Technologies Announces Publication of Peer-Reviewed Analysis Demonstrating Improvement in Obstructive Sleep Apnea Severity with Neuromuscular Electrical Stimulation
Signifier Medical Technologies LLC (“Signifier” or the “Company”), a Boston-based medical technology company, announced that a peer-reviewed paper has recently been accepted for publication in Sleep and Breathing. The analysis, published by University of California San Diego investigators Dr. Brandon Nokes, Professor Atul Malhotra, and other collaborators, is based on a post-hoc analysis of 65 participants with mild obstructive sleep apnea (OSA) who completed sleep testing before and after six weeks of genioglossus (tongue muscle) neuromuscular electrical stimulation (NMES) with eXciteOSA.
The first of its kind, eXciteOSA is an FDA-authorized, non-invasive daytime treatment for snoring and mild OSA. Unlike other treatment options, this does not require a nighttime wearable, which allows patients to conveniently fit therapy into their daily routine. The therapy works by using NMES to build the endurance of the genioglossus muscle so that the tongue doesn’t collapse into the airway during sleep. The eXciteOSA device is used for only 20 minutes per day for six weeks and then a minimum of twice per week thereafter for maintenance.
Based on the data from the peer-reviewed analysis, the researchers observed a significant improvement in the apnea-hypopnea index (AHI) from 10.2 to 6.8 events/hour (33%) among all participants, and from 10.4 to 5.0 events/hour (52%) in the responder subgroup which represented 78% of the study sample (51 of 65). Statistically-significant improvements in self-reported sleepiness, sleep quality, objectively measured snoring, and bed partner-reported snoring were observed. Average adherence to eXciteOSA therapy was 85%.
The Sleep and Breathing article can be found here:
eXciteOSA has the benefit of being a daytime-only treatment modality which confers a high level of tolerability and patient acceptance. It alleviates the need for an in situ device during sleep and is associated with improvements in OSA severity, snoring, sleepiness, and sleep quality. Further studies are needed to define which individuals may benefit most from the device across the wider spectrum of OSA severity and assess long-term therapeutic outcomes. Signifier Medical Technologies is supporting four clinical trials on these topics, currently underway.
Signifier is a pioneer in addressing a key root cause of sleep disordered breathing. We are focused on the development and commercialization of innovative and non-invasive solutions that help people breathe normally and naturally all night – entirely on their own. The publication of this study in conjunction with ongoing clinical trials represents Signifier Medical’s commitment to research of therapies that improve population health, increase the quality of patients’ experience, and generate healthcare savings.
About Signifier Medical Technologies
Signifier is a pioneer in addressing the root causes of sleep disordered breathing. We are focused on the development and commercialization of innovative and non-invasive solutions that help people breathe normally and naturally all night – entirely on their own. Founded in 2015, Signifier is at the forefront of sleep therapy, with a mission to develop therapies that improve population health, increase the quality of patients’ experience and generate healthcare savings. Signifier has offices in London (UK), Needham (Massachusetts, USA) and Berlin (Germany).
eXciteOSA is a revolutionary daytime therapy device for sleep disordered breathing. Clinically proven to target a common root cause of OSA, eXciteOSA improves sleep quality, health and quality of life. Nearly one billion adults aged 30 to 69 years globally are estimated to suffer from OSA, which is a serious medical condition associated with health problems such as high blood pressure and increased risks of heart attack, stroke or death.1-10
A major underlying cause of OSA is that the upper airway muscles lack endurance during sleep and the tongue falls back, blocking the upper airway. By using neuromuscular electrical stimulation (NMES) to “exercise” the upper airway muscles, eXciteOSA works the intrinsic and extrinsic tongue muscles to improve endurance and prevent airway collapse during sleep.
Unlike other devices which are used while patients sleep, eXciteOSA is the first commercially available device used while awake. The full benefits of the daytime therapy are realized without patient use during sleep.
About Snoring and Obstructive Sleep Apnea
Nearly one billion adults aged 30 to 69 years are estimated to have OSA globally.1 OSA and snoring are problems for many people whose tongue muscles relax during sleep, causing airway collapse and decreased oxygen intake, which causes the sleeper to stop and restart breathing during sleep, often jolting them awake.15-16
OSA is a serious medical condition associated with health problems like high blood pressure and increased risks of heart attack, stroke, or death.2-9 OSA and snoring also affect patients’ partners and family members, consequently putting strain on relationships.15-16
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- Peker Y, Hedner J, Norum J, et al. Increased incidence of cardiovascular disease in middle-aged men with obstructive sleep apnoea: a 7-year follow-up. Am J Respir Crit Care Med. 2002; 166:159– 165. [PubMed: 12119227]
- Marin JM, Carrizo SJ, Vicente E, et al. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005; 365:1046–1053. [PubMed: 15781100]
- Peppard PE, Szklo-Coxe M, Hla KM, et al. Longitudinal association of sleep-related breathing disorder and depression. Arch Intern Med. 2006; 166:1709–1715. [PubMed: 16983048]
- Kendzerska T, Gershon AS, Hawker G, et al. Obstructive sleep apnoea and incident diabetes: a historical cohort study. Am J Respir Crit Care Med. 2014; 190:218–225. [PubMed: 24897551]
- Johnson KG and Johnson DC. Frequency of sleep apnea in stroke and TIA patients: a meta-analysis. J of Clinical Sleep Med 2010;6(2):131-7
- Baptista et al. Daytime Neuromuscular Electrical Therapy of Tongue Muscles in Improving Snoring. 2021
- Kotecha. et al. A novel intraoral neuromuscular stimulation device for treating sleep-disordered breathing. Sleep Breath. 2021.
- Data on File. Signifier Medical Technologies
- Davey, M. J. Epidemiological study of snoring from a random survey of 1075 participant. British Snoring and Sleep Apnoea Association. 2002; Available at: https://britishsnoring.co.uk/pdf/epidem.pdf
- Levy P, Kohler M, McNicholas WT, et al. Obstructive sleep apnoea syndrome. Nat Rev Dis Primers 2015; 1: 15015.
- Luyster FS. Impact of Obstructive Sleep Apnea and Its Treatments on Partners: A Literature Review. J Clin Sleep Med. 2017;13(3):467-477.