Hypoglossal Nerve Stimulation (HGNS) for Obstructive Sleep Apnea (OSA): A Systematic Review and Meta-Analysis of Patient-Reported Outcomes

Author(s)

Wollny M1, Heiser C2, Schoebel C3, Sommer UJ4, Braun M5
1MedImbursement, Tarmstedt, NI, Germany, 2Technical University Munich, Munich, Germany, 3University Hospital Essen, Essen, NW, Germany, 4HNO-ZENTRUM Mangfall-Inn, Bad Aibling, BY, Germany, 5University Hospital Essen, Bonn, NW, Germany

OBJECTIVES: Hypoglossal nerve stimulation (HGNS) emerged as an alternative treatment for patients with OSA a decade ago, and numerous studies have demonstrated substantial improvements in disease severity with this therapy by reducing apnea-hypopnea burden and improving quality of life. The objective of this review was to evaluate patient-reported outcomes and experiences with HGNS therapy in a systematic review and meta-analysis.

METHODS: MEDLINE, Cochrane, and Web of Science were systematically searched to identify randomized controlled and observational studies reporting outcomes relevant to HGNS therapy in patients with OSA. Of 406 articles screened, 55 publications were assessed for eligibility and risk of bias using the ROBINS-I tool. Meta-analysis using a fixed-effects model was performed when > 2 studies with data on a specific outcome were available.

RESULTS: Thirty-four studies with a total of 3,785 patients and a mean follow-up of 11.8 ± 12.2 months were identified and included in the meta-analysis. The fixed effects model showed a pooled effect size of 4.59 points improvement in daytime sleepiness as measured by the ESS questionnaire (Z= 42.82, p < .001), 2.84 points improvement in daytime functioning as measured by the FOSQ score (Z= 28.38, p < .001), and 1.77 points improvement in sleep quality as measured by the PSQI questionnaire (Z= 2.53, p = .010). Patient-reported outcomes were positive in all identified studies, adding relevant information about care processes and perceptions of therapy.

CONCLUSIONS: HGNS leads to significant improvements in health-related quality of life in patients with OSA and reliably produces clinically meaningful changes in daytime sleepiness, daytime functioning, and sleep quality. The therapy regularly meets or exceeds the minimum clinically important differences defined for the respective instruments. Further research is warranted to examine subjective outcomes beyond improvements in daytime sleepiness and daytime functioning.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

PCR90

Topic

Medical Technologies, Methodological & Statistical Research, Patient-Centered Research, Study Approaches

Topic Subcategory

Literature Review & Synthesis, Medical Devices, Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods

Disease

Medical Devices, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)

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