Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.
Eur Respir J
; 55(1)2020 01.
Article
em En
| MEDLINE
| ID: mdl-31601716
ABSTRACT
BACKGROUND AND AIM:
Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6â months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA the Genio™ system.METHODS:
This prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea-hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604.RESULTS:
22 out of 27 implanted participants (63% male, aged 55.9±12.0â years, body mass index (BMI) 27.4±3.0â kg·m-2) completed the protocol. At 6â months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1â events·h-1, a mean change of 10.8â events·h-1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9â events·h-1, a mean change of 9.3â events·h-1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5â days per week, and 77% reported use for >5â h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.CONCLUSIONS:
Bilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Apneia Obstrutiva do Sono
/
Nervo Hipoglosso
Tipo de estudo:
Clinical_trials
/
Guideline
/
Observational_studies
/
Risk_factors_studies
Limite:
Adult
/
Female
/
Humans
/
Male
País/Região como assunto:
Europa
/
Oceania
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article