Faculty Collaboration Database

Implanted upper airway stimulation device for obstructive sleep apnea. Laryngoscope 2012 Jul;122(7):1626-33

Date

05/03/2012

Pubmed ID

22549513

DOI

10.1002/lary.23301

Scopus ID

2-s2.0-84862894466 (requires institutional sign-in at Scopus site)   203 Citations

Abstract

OBJECTIVES/HYPOTHESIS: Previous feasibility studies have shown that electrical stimulation of the hypoglossal nerve can improve obstructive sleep apnea (OSA). The current study examined the safety and preliminary effectiveness of a second generation device, the Upper Airway Stimulation (UAS) system, and identified baseline predictors for therapy success.

STUDY DESIGN: Two consecutive open prospective studies.

METHODS: UAS systems were implanted in patients with moderate to severe OSA who failed or were intolerant of continuous positive airway pressure (CPAP). The study was conducted in 2 parts. In part 1, patients were enrolled with broad selection criteria. Apnea hypopnea index (AHI) was collected using laboratory-based polysomnography at preimplant and postimplant visits. Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ) were also collected. In part 2, patients were enrolled using selection criteria derived from the experience in part 1.

RESULTS: In part 1, 20 of 22 enrolled patients (two exited the study) were examined for factors predictive of therapy response. Responders had both a body mass index ≤32 and AHI ≤50 (P < .05) and did not have complete concentric palatal collapse. Part 2 patients (n = 8) were selected using responder criteria and showed an improvement on AHI from baseline, from 38.9 ± 9.8 to 10.0 ± 11.0 (P < .01) at 6 months postimplant. Both ESS and FOSQ improved significantly in part 1 and 2 subjects.

CONCLUSIONS: The current study has demonstrated that therapy with upper airway stimulation is safe and efficacious in a select group of patients with moderate to severe OSA who cannot or will not use CPAP as primary treatment.

Author List

Van de Heyning PH, Badr MS, Baskin JZ, Cramer Bornemann MA, De Backer WA, Dotan Y, Hohenhorst W, Knaack L, Lin HS, Maurer JT, Netzer A, Odland RM, Oliven A, Strohl KP, Vanderveken OM, Verbraecken J, Woodson BT

Author

B Tucker Woodson MD Chief, Professor in the Otolaryngology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Electric Stimulation Therapy
Feasibility Studies
Female
Humans
Implantable Neurostimulators
Male
Middle Aged
Prospective Studies
Sleep Apnea, Obstructive