Bilateral transcutaneous auricular vagus nerve stimulation reduces excessive daytime sleepiness in patients with narcolepsy type 1 compared to sham stimulation
This study protocol describes a randomized, double-blind, sham-controlled trial (TARGET-2) evaluating the efficacy and safety of bilateral taVNS versus unilateral taVNS and sham stimulation in 153 patients with narcolepsy type 1. The primary outcome is the change in Epworth Sleepiness Scale (ESS) score from baseline to 12 weeks. The trial is ongoing, with anticipated completion by March 2027.
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Bilateral transcutaneous auricular vagus nerve stimulation reduces excessive daytime sleepiness in patients with narcolepsy type 1 compared to sham stimulation The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 42/100 (low).
The Claim
Bilateral transcutaneous auricular vagus nerve stimulation reduces excessive daytime sleepiness in patients with narcolepsy type 1 compared to sham stimulation
This conclusion is most relevant to: Patients with narcolepsy type 1 (NT1) recruited from four centers in China.
How It Works
The proposed biological pathway:
- ▸taVNS activates vagal afferent fibers
- ▸Modulates brainstem and cortical arousal networks
- ▸Regulates sleep-wake cycles and neural network activity
- ▸Reduces excessive daytime sleepiness and cataplexy
Who Might Benefit
Evidence fit by population:
- ▸Patients with narcolepsy type 1 (NT1) recruited from four centers in China
Recommended Dose
30 minutes per session, twice daily for 12 weeks
Limitations & Caveats
Important context when interpreting this evidence:
- ▸Results are not yet available; this is a study protocol only
- ▸Single-country study (China) may limit generalizability
- ▸Sham stimulation may not be perfectly inert due to minimal intensity