Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea

Strohl, Madeleine P.; Yamauchi, Motoo; Peng, Zhe

doi:10.1007/s40675-017-0088-x

Cited by 14 publications

(8 citation statements)

References 68 publications

(82 reference statements)

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“…Two months later, a full-night lab titration study is conducted to ensure the effectiveness of the Inspire settings (mainly functional threshold) in all sleep stages and in all sleep positions. Then, follow up visits at 3, 6, and 12 months can be scheduled to evaluate the long-term clinical outcome [ 29 ].…”

Section: Implantation Process (Surgical Technique) Pre- and Post-mentioning

confidence: 99%

The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea—A Literature Review

Mashaqi

Patel

Combs

et al. 2021

IJERPH

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Obstructive sleep apnea (OSA) is a common sleep disorder that affects all age groups and is associated with many co-morbid diseases (especially cardiovascular diseases). Continuous positive airway pressure (CPAP) is the gold standard for treating OSA. However, adherence to PAP therapy has been a major challenge with an estimated adherence between 20 and 80%. Mandibular advancement devices (MAD) are a good alternative option if used in the appropriate patient. MAD are most effective in mild and moderate OSA but not severe OSA. Surgical options are invasive, not appropriate for severe OSA, and associated with pain and long healing time. Hypoglossal nerve stimulation (HGNS), or upper airway stimulation (UAS), is a novel therapy in treating moderate and severe degrees of OSA in patients who cannot tolerate CPAP therapy. We reviewed the MEDLINE (PubMed) database. The search process yielded 303 articles; 31 met the inclusion and exclusion criteria and were included. We concluded that hypoglossal nerve stimulation is a very effective and novel alternative therapy for moderate and severe OSA in patients who cannot tolerate CPAP therapy. Adherence to HGNS is superior to CPAP. However, more developments are needed to ensure the highest safety profile.

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Section: Implantation Process (Surgical Technique) Pre- and Post-mentioning

confidence: 99%

The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea—A Literature Review

Mashaqi

Patel

Combs

et al. 2021

IJERPH

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show abstract

“…24 Although HNS is often described as a surgical procedure for highly selected patients, the three major inclusion criteria indicated by the Food and Drug Administration (FDA) are moderate to severe OSA (AHI between 15 and 65), body mass index (BMI) <32 kg/m 2 , and absence of complete concentric collapse (CCC) at the soft palate level. 25 Baseline AHI is a fundamental measure for OSA severity, and it should be taken into account when the treatment is chosen. The STAR trial 26 used an AHI between 20 and 50 events per hour as an important inclusion criteria.…”

Section: Patient Selection and Efficacy Predictorsmentioning

confidence: 99%

<p>Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea: Patient Selection and New Perspectives</p>

Baptista¹,

Costantino²,

Moffa³

et al. 2020

NSS

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Hypoglossal nerve stimulation (HNS) is an increasingly widespread OSA treatment. It is a non-anatomical modifying surgery able to achieve an adequate objective and subjective result with a reasonable complication rate. HNS exploits the neurostimulation to reduce upper airway collapsibility providing a multilevel upper airway improvement within a single procedure. Proper patient selection has a fundamental role in determining an adequate long-term clinical outcome. All patient candidates for HNS undergo a standard comprehensive sleep medicine assessment and upper airway surgical examination. Several features should be assessed preoperatively in order to predict patients' response to HNS treatment. In particular, the assessment of OSA severity, BMI > 32 Kg/m 2 , collapse pattern during drug-induced sleep endoscopy (DISE), and many other parameters, is central for a good patient selection and customization of OSA treatment. HNS is indeed one of the most promising tools in the widespread context of personalized sleep medicine. HNS is an adjustable medical device that could be titrated in order to improve HNS effectiveness, maintaining patient comfort. Moreover, HNS provides the opportunity for patients to play an active role in their own care, with a potential improvement in therapy adherence and efficacy. This review summarizes the current evidence in patient selection for HNS, highlighting the reasons behind the optimistic future of this OSA treatment in the context of personalized medicine.

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“…Accordingly, numerous studies have since confirmed and expounded on the efficacy initially reported in the STAR trial. 4 Interestingly, a recent 5-year analysis of the STAR cohort suggested that older adults might exhibit a more robust response than younger adults following UAS. 5…”

mentioning

confidence: 99%

Upper Airway Stimulation Response in Older Adults with Moderate to Severe Obstructive Sleep Apnea

Withrow

Evans

Harwick

et al. 2019

Otolaryngol.--head neck surg.

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Objective To evaluate the impact of age on safety, efficacy, and usage of upper airway stimulation (UAS). Study Design Multicenter observational study. Setting Thirteen US hospitals and 3 German hospitals. Subjects and Methods The ADHERE registry is a multicenter database enrolling patients undergoing UAS implantation from October 2016 to April 2018. Outcome measures included the Epworth Sleepiness Scale, apnea-hypopnea index (AHI), therapy usage, and complications. Data were segmented by age (<65 vs ≥65 years). Results Younger adults (n = 365) were a mean ± SD 52.7 ± 7.9 years old and 82% male, with a body mass index of 29.6 ± 3.8. Older adults (n = 235) were 71.1 ± 4.8 years old and 71% male, with a body mass index of 28.8 ± 3.8. Baseline AHI was similar (younger, 36.2 ± 15.9; older, 36.1 ± 14.8). Both groups had lower AHI at 12 months versus baseline ( P < .001), but the older group showed a greater reduction (7.6 ± 6.9 vs 11.9 ± 13.4, P = .01). The Epworth Sleepiness Scale score decreased from 12.3 ± 5.4 to 7.1 ± 4.8 ( P < .001) among younger adults and from 10.7 ± 5.7 to 6.3 ± 4.4 ( P < .001) among older adults. Usage was slightly higher among older adults (6.0 ± 2.0 vs 5.4 ± 2.1 hours/night, P = .02). Surgical time was similar between younger patients (2.4 ± 0.7 hours) and older patients (2.3 ± 0.7 hours, P = .40), with comparably low complications. Conclusion AHI reduction and therapy usage were found to be somewhat higher among patients aged ≥65 years who were treated with UAS. Surgical complications were low, in contrast to traditional sleep surgery.

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Insights since FDA Approval of Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea

Cited by 14 publications

References 68 publications

The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea—A Literature Review

The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea—A Literature Review

<p>Hypoglossal Nerve Stimulation in the Treatment of Obstructive Sleep Apnea: Patient Selection and New Perspectives</p>

Upper Airway Stimulation Response in Older Adults with Moderate to Severe Obstructive Sleep Apnea

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