Association Between Conflict of Interest and Published Position on Hypoglossal Nerve Stimulation for Sleep Apnea

Objective To determine if there is an association between authors’ financial conflict of interest and published position on clinical use of hypoglossal nerve stimulation for obstructive sleep apnea. Study Design Retrospective cross-sectional analysis. Setting International roster of authors and articles analyzed. Methods A Google Scholar search was performed for editorials and reviews citing the 2014 New England Journal of Medicine article on hypoglossal nerve stimulation for obstructive sleep apnea. Included articles were coded as favorable or neutral. Conflict of interest was recorded as declared by the authors in these articles and as independently searched in the Open Payments registry. Results Sixteen articles from 45 independent authors were analyzed. Nine articles by authors were coded as favorable. Among authors of articles with favorable views, 16 (59%) had a financial conflict of interest with the manufacturer of the hypoglossal nerve stimulator device, as opposed to only 1 of 21 (5%) authors of neutral/unfavorable articles. When we included only authors to whom payments could be identified or excluded on Open Payments, 16 of 20 (80%; 95% CI, 62%-98%) authors of favorable articles had a financial conflict, while 1 of 10 (10%; 95% CI, 0%-29.6%) of neutral/unfavorable articles did ( P = .004). Conclusion Our study demonstrates an association between published position on hypoglossal nerve stimulator use and financial conflict with the device manufacturer. Several undeclared conflicts were also found, suggesting a role for independent search for conflicts during the review process.

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1226 A Case of Hypoglossal Nerve Stimulation Induced Cheyne-Stoke Central Sleep Apnea

SLEEP ◽

10.1093/sleep/zsaa056.1220 ◽

2020 ◽

Vol 43 (Supplement_1) ◽

pp. A468-A468

Author(s):

Talayeh Rezayat ◽

Melisa Chang

Keyword(s):

Heart Failure ◽

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Central Sleep Apnea ◽

Nerve Stimulator ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep ◽

History Of

Abstract Introduction Treatment of obstructive sleep apnea (OSA) with positive airway pressure (PAP), mandibular advancement devices (MAD) and oral surgery have been reported to lead to emergent central sleep apnea (CSA). In this case report the emergence of CSA in a Cheyne-Stokes pattern following the use of hypoglossal nerve stimulator as a treatment modality for OSA is discussed. Report of Case A 70-year-old man with a history of hypothyroidism and severe OSA diagnosed via a home sleep apnea test with a respiratory event index (REI) of 38 events/ hr was intolerant of PAP therapy and an MAD did not effectively treat his OSA. He was deemed an appropriate candidate for hypoglossal nerve stimulation following a drug induced sleep endoscopy. Following implantation and activation, he developed a lip droop and was ruled out for a stroke. A polysomnogram was completed which showed significant improvement in his sleep apnea at a voltage range of 1.4-17V. At 1.8V he developed REM- supine central events. When the voltage was further increased to 1.9-2.0V non-REM supine central events arose. These events appeared to have Cheyne-Stoke morphology with a cycle duration of over 50s. He was set to an amplitude of 1.6 V with a positional belt for treatment of his OSA without any emergent CSA. Conclusion This patient developed central sleep apneas with Cheyne-Stoke morphology following treatment of obstructive sleep apnea using a hypoglossal nerve stimulator. The central events began at higher voltage settings (greater than 1.8V). He had no history of heart failure or arrhythmias. This higher voltage may lead to overshoot of the tongue out of the airway resulting in hyperpnea, hypocapnia and central apnea but the underlying pathophysiology for the Cheyne-Stoke pattern in the absence of heart failure remains unknown.

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Hypoglossal Nerve Stimulation Therapy for the Treatment of Obstructive Sleep Apnea

Neurotherapeutics ◽

10.1007/s13311-021-01012-x ◽

2021 ◽

Cited By ~ 1

Author(s):

Michael D. Olson ◽

Mithri R. Junna

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep

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Tongue-Based Procedures in Treating Refractory Obstructive Sleep Apnea in Down Syndrome Patients: A Systematic Review and Meta-Analysis

FACE ◽

10.1177/2732501621992447 ◽

2021 ◽

Vol 2 (1) ◽

pp. 65-70

Author(s):

Paul B. Lee ◽

Michael T. Chung ◽

Jared Johnson ◽

Jordyn Lucas ◽

Caitlin R. Priest ◽

...

Keyword(s):

Systematic Review ◽

Obstructive Sleep Apnea ◽

Down Syndrome ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Meta Analysis ◽

Apnea Hypopnea Index ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep

Objective: There is a high prevalence of obstructive sleep apnea (OSA) in pediatric and adult Down Syndrome (DS) patients that is refractory to adenotonsillectomy and continuous positive airway pressure. Newer treatment modalities have emerged with improved outcomes. The objective is to provide an updated systematic review and meta-analysis to analyze the clinical outcomes of OSA in pediatric and adult DS patients with hypoglossal nerve stimulation using Inspire, midline posterior glossectomy plus lingual tonsillectomy (MPG + LT), and combined genioglossus advancement plus radiofrequency (GGS + RF). Methods: A comprehensive literature search of PubMed and Google Scholar was performed followed by a meta-analysis. Studies with preoperative and post-operative Apnea Hypopnea Index (AHI) values were included with patients serving as their own control. Results: Across 5 studies, 56 patients were analyzed. The mean reduction in AHI was statistically significant before vs. after procedure ( P < .001 for hypoglossal nerve stimulation using Inspire with a paired 2-tailed t-test and P = .031 for MPG + LT). Although individual patient AHI values were unavailable in the GGS + RF study, the standard difference in mean AHI was also significant for GGS + RF with P = .001. Device malfunction was the most common complication for Inspire while postoperative bleeding was observed for MPG + LT and nasopharyngeal obstruction and retropalatal collapse were observed for GGS + RF. Conclusion: This review reveals significant improvement in AHI with Inspire, MPG + LT, and GGS + RF for DS patients with refractory OSA. Further investigation is needed for comparison between these 3 therapies.

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Hypoglossal Nerve Stimulation in Veterans with Obstructive Sleep Apnea

The Laryngoscope ◽

10.1002/lary.28422 ◽

2019 ◽

Vol 130 (9) ◽

pp. 2275-2280 ◽

Cited By ~ 1

Author(s):

Kathleen M. Sarber ◽

Katherine W. Chang ◽

Madison V. Epperson ◽

Meredith E. Tabangin ◽

Mekibib Altaye ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep

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Endotypic Mechanisms of Successful Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

American Journal of Respiratory and Critical Care Medicine ◽

10.1164/rccm.202006-2176oc ◽

2020 ◽

Author(s):

Sara Op de Beeck ◽

Andrew Wellman ◽

Marijke Dieltjens ◽

Kingman P Strohl ◽

Marc Willemen ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Hypoglossal Nerve ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep

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Therapeutic Positive Airway Pressure Level Predicts Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea

Journal of Clinical Sleep Medicine ◽

10.5664/jcsm.7814 ◽

2019 ◽

Vol 15 (08) ◽

pp. 1165-1172 ◽

Cited By ~ 7

Author(s):

Clara H. Lee ◽

Everett G. Seay ◽

Benjamin K. Walters ◽

Nicholas J. Scalzitti ◽

Raj C. Dedhia

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Nerve Stimulation ◽

Airway Pressure ◽

Hypoglossal Nerve ◽

Positive Airway Pressure ◽

Pressure Level ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep

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Effectiveness of Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea (Meta-analytic Study)

QJM ◽

10.1093/qjmed/hcaa047.003 ◽

2020 ◽

Vol 113 (Supplement_1) ◽

Author(s):

M Mahmoud ◽

A Mohamed ◽

H Nasr

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Outcome Measures ◽

Nerve Stimulation ◽

Primary Outcome ◽

Hypoglossal Nerve ◽

Mean Difference ◽

Hypoglossal Nerve Stimulation ◽

Obstructive Sleep ◽

Standardized Mean Difference

Abstract Background Obstructive sleep apnea (OSA) is a serious, potentially life-threatening disorder. There are many treatment modalities are being used, but none of them gained consensus. Continuous positive airway pressure considered the most widely accepted treatment of OSA but very poor adherence limits its effectiveness, thus was the need for alternative therapy of high compliance and effective for long term. Aim of the Work To perform a meta-analysis of the available studies included outcomes of hypoglossal nerve stimulation to evaluate its effectiveness as a choice of treatment of obstructive sleep apnea. Patients and Methods The study included published medical articles that evaluated the efficacy of hypoglossal nerve stimulation as treatment of obstructive sleep apnea with outcomes for primary outcome measures apnea-hypopnea index (AHI), oxygen desaturation index (ODI), and for secondary outcome measures Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ) before and after implantation. Results Eight prospective studies with 329 patients were included in this met analysis. At 12 months, statistical analysis demonstrated significant reductions in AHI, ODI with standardized mean difference of -1.3940 (95% CI: -1.7745 to -1.0136; P = 0.0042), -0.9188 (95% CI: -1.3040 to -0.5337; p = 0.0002) respectively, and -not significant- reduction in ESS, FOSQ with standardized mean difference of -1.0365 (95% CI: -1.1889 to -0.8841; p = 0.2290), 1.0545 (95% CI: 0.8867 to 1.2223; p = 0.4922), respectively. Similar were observed at 6 months. Conclusion Hypoglossal nerve stimulation results in significant improvement of primary outcome measures of OSA with significant reduction of apnea episodes. It could be considered as an effective -but still of high cost- alternative for OSA patients. Further studies comparing HNS to other therapies are needed.

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