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Sleep Apnea

Sleep Apnea

Sleep apnea is a condition where breathing stops intermittently during sleep, often leading to significant health issues. Each episode can last from 10 to 20 seconds or more and is frequently accompanied by a brief arousal from sleep. This disturbance, largely unnoticed by the individual, can lead to severe daytime fatigue. Commonly, individuals seek help after being informed by their partners about loud snoring and noticeable breathing pauses during sleep.
The condition is more prevalent among...

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Targeted Hypoglossal Nerve Stimulation for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

Alan R Schwartz^1,2, Ofer Jacobowitz³, David W Eisele⁴

¹Department of Otorhinolaryngology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

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|April 6, 2023

Summary

Targeted hypoglossal nerve stimulation (THN) improved obstructive sleep apnea (OSA) severity, sleepiness, and quality of life in a randomized trial. This OSA treatment shows promise for patients lacking other effective options.

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Area of Science:

Sleep Medicine
Neuromodulation
Clinical Trials

Background:

Randomized clinical trials on hypoglossal nerve stimulation for obstructive sleep apnea (OSA) are limited.
Targeted hypoglossal nerve stimulation (THN) offers a potential treatment avenue for OSA patients.

Purpose of the Study:

To evaluate the safety and effectiveness of THN targeting the proximal hypoglossal nerve in moderate to severe OSA patients.
To assess THN's impact on apnea-hypopnea index (AHI), oxygen desaturation index (ODI), and patient-reported outcomes.

Main Methods:

A randomized clinical trial (THN3) involving 138 patients with moderate to severe OSA (AHI 20-65, BMI ≤35).
Participants were randomized 2:1 to THN activation at month 1 or month 4, with 11 months of treatment and follow-up at 12 and 15 months.
Primary endpoints included AHI and ODI responder rates; secondary endpoints covered sleep apnea severity and quality of life measures.

Main Results:

At 4 months, THN significantly increased AHI and ODI responder rates compared to the control group (AHI: 52.3% vs 19.6%; ODI: 62.5% vs 41.3%).
Clinically meaningful improvements were observed in AHI, ODI, and patient-reported outcomes (sleepiness, quality of life) at 12/15 months.
Two serious and 100 non-serious adverse events related to the implant or protocol were reported.

Conclusions:

Targeted hypoglossal nerve stimulation (THN) effectively improves OSA, reduces sleepiness, and enhances quality of life.
THN demonstrates favorable outcomes compared to distal hypoglossal nerve stimulation, particularly for AHI and patient-reported responses.