Insomnia affects patient‐reported outcome in sleep apnea treated with hypoglossal nerve stimulation

Steffen, Armin; Baptista, Peter; Ebner, Eva-Maria; Jeschke, S; König, Inke R.; Bruchhage, Karl‐Ludwig

doi:10.1002/lio2.761

Cited by 10 publications

(28 citation statements)

References 29 publications

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“…On one hand, there are the cohort studies entitled STAR 24 38 39 40 and the German Postmarket study 31 41 42 43 as well as the registry study called ADHERE 44 45 including the prospective comparative study 46 initiated and supported by the manufacturer of Inspire Medical Company. On the other hand, there are independent cohort trials of larger implantation centers with sometimes several years of follow-up examinations 47 48 49 50 51 and the randomized controlled therapy withdrawal study of EFFECT 52 .…”

Section: Patient-related Outcome: Measurements and Resultsmentioning

confidence: 99%

“…Another cohort evaluation revealed in the follow-up that 68 of a total of 132 patients who had been treated for at least 3 years achieved a reduction from 14 to 7 points in the ESS. However, if clinically relevant insomnia is complained at the same time, the reduction amounts to only 3.5 points [50].…”

Section: Stimulation Of the Hypoglossal Nerve For Obstructive Sleep A...mentioning

confidence: 96%

“…In einer anderen Kohortenauswertung weisen die 68 der hier insgesamt 132 untersuchten Nachsorgepatienten, welche mindestens 3 Jahre lang versorgt wurden, eine deutliche Reduktion von 14 auf 7 Punkte im ESS auf. Werden allerdings parallel klinisch relevante insomnische Beschwerden beklagt, ist die Reduktion lediglich bei 3,5 Punkten [50].…”

Section: Stimulation Des Nervus Hypoglossus Bei Obstruktiver Schlafapnoeunclassified

“…5,0 Stunden die The-rapie weniger nutzten [53]. Patienten mit klinisch relevanten insomnischen Beschwerden wiesen mit 5,2 Stunden eine verringerte Nutzung auf gegenüber den ohne Insomnie mit 6,1 Stunden [50].…”

Section: Stimulation Des Nervus Hypoglossus Bei Obstruktiver Schlafapnoeunclassified

“…Inspire Medical initiierten und unterstützten prospektiven Kohortenstudien STAR 24 38 39 40 und die German-Postmarket Studie 31 41 42 43 sowie die Registerstudie ADHERE 44 45 inklusive der prospektiven Vergleichsstudie im Wartearmdesign 46 . Zum anderen gibt es unabhängige Kohortenstudien von größeren Implantationszentren mit teilweise mehrjährigen Nachuntersuchungen 47 48 49 50 51 und die randomisierte kontrollierte Therapieentzugsstudie EFFECT 52 .…”

Section: Patientenbenefit: Messinstrumente Und Ergebnisseunclassified

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Patienten relevanter Nutzen und Therapieeffekte in der Stimulationstherapie bei schlafbezogenen Atmungsstörungen

Steffen¹

2022

Laryngorhinootologie

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ZusammenfassungFür die Therapie verschiedener schlafbezogene Erkrankungen und das Schnarchen stehen mittlerweile mehrere Neurostimulationsverfahren zur Verfügung. Zur Behandlung der obstruktiven Schlafapnoe (OSA) existieren überwiegend Daten für die atmungsgesteuerte Hypoglossusnervstimulation (HNS), welche die Senkung der Tagesschläfrigkeit in der Epworth Sleepiness Scale (ESS) in zahlreichen Publikationen übereinstimmend und für mehrere Jahre stabil um gut 5 Punkte zeigen konnte. Die schlafbezogene Lebensqualität im Functional Outcomes of Sleep Questionnaire erbringt in mehreren Kohorten eine Besserung um gut 2 Punkte. Zahlreiche Arbeiten zeigen eine durchschnittliche Nutzung von 5 bis 6 Stunden. Unter Berücksichtigung kürzerer Nachsorgeintervalle und kleinerer Kohorten sinkt der ESS bei der unilateralen kontinuierlichen HNS um 4 und bei der bilateralen um 3 Punkte. Zur Behandlung der zentralen Schlafapnoe ist die transvenöse Stimulation der Nervus phrenicus zugelassen, bei welcher sich in einer Schlüsselstudie mit fünfjähriger Nachbeobachtung der ESS um 3 Punkte gesenkt werden konnte. Die Therapiezeit beträgt in einer Arbeit gut 5 Stunden. Mit der enoralen Stimulationstherapie gegen das Schnarchen konnte der ESS um gut 2 Punkte gesenkt und die schlafbezogene Lebensqualität sowohl des Schnarchenden als auch des Bettpartners gesteigert werden. Die Adhärenz zum täglichen Training für die nächtlichen Effekte wird mit 83% angegeben. Sowohl für die HNS, Phrenicusstimulation als auch die enorale Stimulationstherapie laufen weitere (Register-)Studien bzw. sind angekündigt, welche Patienten relevante Endpunkte berücksichtigen.

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Section: Patient-related Outcome: Measurements and Resultsmentioning

confidence: 99%

Section: Stimulation Of the Hypoglossal Nerve For Obstructive Sleep A...mentioning

confidence: 96%

Section: Stimulation Des Nervus Hypoglossus Bei Obstruktiver Schlafapnoeunclassified

Section: Patientenbenefit: Messinstrumente Und Ergebnisseunclassified

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Patienten relevanter Nutzen und Therapieeffekte in der Stimulationstherapie bei schlafbezogenen Atmungsstörungen

Steffen¹

2022

Laryngorhinootologie

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Impact of Insomnia on Hypoglossal Nerve Stimulation Outcomes in the ADHERE Registry

et al. 2023

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ObjectiveWe aimed to determine the preoperative prevalence of insomnia in the Adherence and Outcomes of Upper Airway Stimulation for OSA International Registry (ADHERE) and to examine serial sleep‐related data longitudinally, in particular the Insomnia Severity Index (ISI), to compare outcomes between patients with no/subthreshold insomnia (ISI < 15) and moderate/severe insomnia (ISI ≥ 15) at baseline.MethodsWe analyzed observational data from ADHERE between March 2020 and September 2022. Baseline demographic and mental health (MH) data, apnea hypopnea index (AHI), ISI, and ESS (Epworth Sleepiness Scale) were recorded. At post‐titration (PT) and final visits, AHI, ISI, ESS and nightly usage were compared between baseline ISI < 15 and ISI ≥ 15 subgroups.ResultsA baseline ISI was obtained in 928 patients (62% with ISI ≥ 15). Of the 578 and 141 patients reaching the 12‐ and 24‐month time periods to complete PT and final visits, 292 (50.5%) and 91 (64.5%) completed the ISI, respectively. Baseline MH conditions were higher with ISI ≥ 15 than ISI < 15 (p < 0.001). AHI reduction and adherence did not differ between patients with baseline ISI ≥ 15 and ISI < 15. Patients with ISI ≥ 15 experienced greater improvement in ESS than ISI < 15 at post‐titration and final visits (p = 0.014, 0.025). All patients had improved nocturnal, daytime, and overall ISI scores at follow‐up visits (p < 0.001), especially for those with baseline ISI ≥ 15 compared with ISI < 15 (p < 0.05).ConclusionHGNS therapy efficacy and adherence were similar between ISI severity subgroups at follow‐up visits. Insomnia and sleepiness scores improved in all patients with HGNS therapy and to a greater degree in patients with baseline moderate/severe insomnia.Level of Evidence4 Laryngoscope, 2023

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Relationship of Nocturnal Insomnia Symptoms and Outcomes After Hypoglossal Nerve Stimulation

Dhanda Patil,

Suurna,

Steffen

et al. 2024

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ObjectiveIn patients undergoing hypoglossal nerve stimulation (HGNS), we examined the Insomnia Severity Index (ISI) to understand how baseline sleep onset insomnia (SOI), sleep maintenance insomnia (SMI), and early morning awakening (EMA) affected postsurgical outcomes.Study DesignObservational.SettingMulticenter registry.MethodsWe included patients from the Adherence and Outcomes of Upper Airway Stimulation for Obstructive Sleep Apnea International Registry (ADHERE) with a baseline ISI from 2020 to 2023. Regression analysis examined the association of ISI question scores for SOI, SMI, and EMA and outcomes: Apnea‐Hypopnea Index (AHI) reduction, device usage, changes in the Epworth Sleepiness Scale (ESS) and overall ISI score, final visit (FV) completion, and satisfaction.ResultsNo relationship was noted between insomnia subtypes and AHI reduction or FV completion. In the subgroup of patients with baseline moderate/severe insomnia, patients with major impairment for SOI used their device 64 min/day longer than those with minimal impairment. Among all patients, those with baseline major impairment for SOI had a 2.3 points greater improvement in ISI from baseline to FV compared to patients with minimal impairment, while patients with baseline major impairment for SMI had a 2.0 and 3.5 points greater improvement in the ESS and ISI than those with minimal impairment. Patients with EMA and moderate/severe baseline insomnia had decreased odds of being satisfied after surgery.ConclusionIn ADHERE, nocturnal symptoms of insomnia did not limit HGNS efficacy or therapy use. Conversely, those with worse insomnia subtype impairments at baseline had improved outcomes related to adherence, sleepiness, and insomnia at the FV.

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Insomnia affects patient‐reported outcome in sleep apnea treated with hypoglossal nerve stimulation

Abstract: The main objective of this manuscript (to assess associations between ISI and outcome measures) and the timing of the follow-up assessment on outcome data was independent research.

Cited by 10 publications

References 29 publications

Patienten relevanter Nutzen und Therapieeffekte in der Stimulationstherapie bei schlafbezogenen Atmungsstörungen

Patienten relevanter Nutzen und Therapieeffekte in der Stimulationstherapie bei schlafbezogenen Atmungsstörungen

Impact of Insomnia on Hypoglossal Nerve Stimulation Outcomes in the ADHERE Registry

Relationship of Nocturnal Insomnia Symptoms and Outcomes After Hypoglossal Nerve Stimulation

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