0510 Feasibility Trial of a Novel Minimally Invasive Tongue Base Suspension Device to Treat Obstructive Sleep Apnea (OSA). (27th April 2018)

• Record Type: Journal Article
• Authors: Catalano, P; Singh, B; Sanders, I; Amirali, A; Buzzard, J
• Is Part Of: Sleep. Volume 41(2018)Supplement 1
• Page Start: A191
• Page End: A192
• Publication Date: 2018-04-27
• Subjects: Sleep -- Physiological aspects -- Periodicals; Sleep disorders -- Periodicals; Sommeil -- Aspect physiologique -- Périodiques; Sommeil, Troubles du -- Périodiques; Sleep disorders; Sleep -- Physiological aspects; Sleep -- physiological aspects; Sleep Wake Disorders; Psychophysiology; Electronic journals; Periodicals; 616.8498
• DOI: 10.1093/sleep/zsy061.509
• Languages: English
• ISSNs: 0161-8105

Abstract

Abstract: Introduction: The Linguaflex tongue retractor (LTR) is inserted into the tongue with a single needle puncture. At the tongue base a small disc rests against the mucosa and is hypothesized to prevent posterior tongue base collapse during sleep. A flexible shaft extends through the tongue to exit at the frenulum to connect to an adjustable anchor. The device works passively and continuously, requiring no input from the patient. Methods: The goal was to demonstrate safety and efficacy of the LTR at 180 days. Sixteen subjects were evaluated with in-lab PSG, endoscopy, questionnaires and x-ray at baseline and at 1, 2, 3 and 6-months (m) after implantation. Three subjects were withdrawn from the study: 2 were referred for tonsillectomy, and 1 for non-compliance. One subject missed the 6-m follow-up. Twelve subjects returning at 6-m had the following mean and ranges: age 39 (29–64), BMI 33 (23–59), AHI 26.5 (11.6–54.4), ESS 13.9 (6–21) and O2 <90% of 16.8 min (1.3–55). Results: The LTR was inserted under propofol in an average of 4.7 (3–18) minutes. Subject pain was rated as 1.7 out of 10 the day following the procedure and decreased to .1 at day 30. Twelve mild AEs were reported. At 180 days the AHI improved 58% (p <.006) with 7 of 12 having 50% improvement and an AHI <20. Time of O2 <90% improved 48% (p<0.2). ESS improved 46% (p <.0001); 8 of 9 subjects with ESS scores >10 were reduced to ≤10. Subjects had no impairment of speech or swallowing and little sensation of the device. Snoring was rated as having decreased by 10 of 12 subjects. All subjects chose to retain the LTR. Conclusion: The feasibility study was considered a success as safety, efficacy and patient acceptance of the LTR were high. Efficacy seems unrelated to OSA severity or BMI; however, decreased efficacy was seen with tonsillar hypertrophy and nasal congestion. Further study is needed to demonstrate persistent efficacy and safety over time. Support (If Any): Linquaflex Inc.