NON-Surgical Adjustable Tongue Advancement Device Developed By Harry Cutler A Sleep Apnea Patient.

A 2007 study (see abstract below) evaluated a surgically implanted tongue advancement device. The article concluded that “Adjustable tongue advancement is a feasible and relatively safe way to reduce the AHI and snoring in selected patients with moderate to severe OSA and CPAP intolerance. Technical improvements and refinements to the procedure are ongoing.”

A sleep apnea patient and inventor Harry Cutler has developed a non-surgical tongue advancement device that can be adapted for labratory titration or auto-titration similar to APAP (auto CPAP)> He is currently pursuing FDA approval to market both OTC and medically prescribed versions. This device also has an adjustable palate lifter as a feature.

I have seen an early prototype and I believe that this oral appliance may be a new class of apnea treatment devices that control the tongue and soft palate to maintain an airway. It can be easily titrated and is non-surgical and therefore will filll an important gap.

TRD’s or tongue retaining devices have limitd use for mild apnea but require a patent nasal airway. The AVEO TSD is an off the shelf device currently available. Additional information on Oral Appliances to treat sleep apnea can be found at http://www.ihatecpap.com

Dr Bryan Keropian has produced the Full Breath Appliance which can be effective but requires numerous visits for titration making it more expensive in terms of cost and time. Mr Cutlers appliace can be titrated by a patient in seconds.

Manufactures and researchers wishing to contact Mr Cutler can e-mail him @ harrycutler@sbcglobal.net

Ann Otol Rhinol Laryngol. 2008 Nov;117(11):815-23.
Adjustable tongue advancement for obstructive sleep apnea: a pilot study.
Hamans E, Boudewyns A, Stuck BA, Baisch A, Willemen M, Verbraecken J, Van de Heyning P.

Department of Otorhinolaryngology-Head and Neck Surgery, University Hospital Antwerp, Antwerp, Belgium. evert.hamans@uza.be
Abstract
OBJECTIVES: Surgical treatment of obstructive sleep apnea (OSA) caused by hypopharyngeal collapse of the upper airway can be considered in patients who are intolerant to continuous positive airway pressure (CPAP). The present procedures addressing the hypopharynx are invasive and have substantial morbidity and limited efficacy.

METHODS: Ten patients (mean age, 44 years) with moderate to severe OSA, ie, an apnea-hypopnea index (AHI) between 15 and 50, with CPAP intolerance were included in a prospective, nonrandomized, multicenter study to evaluate the feasibility, safety, and efficacy of a novel tongue advancement procedure. The procedure consists of the implantation of a tissue anchor in the tongue base and an adjustment spool at the mandible. Titration of this tissue anchor results in advancement of the tongue and a patent upper airway.

RESULTS: The mean AHI decreased from 22.8 at baseline to 11.8 at the 6-month follow-up (p = 0.007). The Epworth Sleepiness Scale score decreased from 11.4 at baseline to 7.7 at the 6-month follow-up (p = 0.094), and the snoring score decreased from 7.5 at baseline to 3.9 at the 6-month follow-up (p = 0.005). Four technical adverse events were noted, and 1 clinical adverse event occurred.

CONCLUSIONS: Adjustable tongue advancement is a feasible and relatively safe way to reduce the AHI and snoring in selected patients with moderate to severe OSA and CPAP intolerance. Technical improvements and refinements to the procedure are ongoing.

PMID: 19102126 [PubMed – indexed for MEDLINE]