USA: A new study has found that targeted hypoglossal nerve stimulation (THN) may be a safe and effective treatment option for patients with obstructive sleep apnea (OSA) published in JAMA: Otolaryngology-Head & Neck Surgery.
The safety and efficacy of stimulating certain parts of the proximal hypoglossal nerve trunk in individuals with moderate to severe Obstructive Sleep Apnea have not been studied, and evidence for this therapy approach is limited.
The randomized clinical trial, THN3, was conducted at 20 centers and included 138 patients with moderate to severe OSA. The trial was conducted from May 2015 through June 2018, and data were analyzed from January 2022 through January 2023. Participants were randomized 2:1 to receive THN activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-ups at months 12 and 15, respectively.
The study revealed the following clinical takeaways:
1.After four months, those in the treatment group had significantly greater improvements in AHI (apnea-hypopnea index) (52.3% vs 19.6%) and ODI (oxygen desaturation index) (62.5% vs 41.3%) than those in the control group.
2.After 12-15 months, the AHI and ODI responder rates were 42.5% and 60.4%, respectively.
3.Patient-reported outcomes, such as the Epworth Sleepiness Scale and EQ-5D visual analog scale scores, also showed clinically meaningful improvements.
4.There were two serious adverse events and 100 nonserious related adverse events related to the implant procedure or study protocol.
The study concluded that THN may be a safe and effective treatment option for patients with OSA. This randomized clinical trial provides important evidence for the effectiveness of THN in treating OSA.
“Clinicians can use these results to help guide treatment decisions for patients with OSA, particularly those who may not be candidates for other treatment options. The study highlights the importance of continued research into new treatment options for OSA, which affects millions of people worldwide.” said the lead author of the study Dr. Alan Schwartz.
Reference:
Schwartz AR, Jacobowitz O, Eisele DW, et al. Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. Published online April 06, 2023. doi:10.1001/jamaoto.2023.0161