CompletedNot Applicable

Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

China60 participantsStarted 2022-04-01

Plain-language summary

The study aimed to examine the efficacy and safety of tVNS as a complementary approach for NT1 by conducting a double-blind, randomized, sham-controlled trial. The specific objectives of the study were as follows: To evaluate the effects of complementary tVNS on the ability to maintain wakefulness, severity of narcolepsy, mood and quality of life in patients with NT1

Who can participate

Age range12 Years – 60 Years

SexALL

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Inclusion criteria

✓. Age ≥ 12 years old with the ability to understand and complete the self-reported questionnaires
✓. The patients met the international classification of sleep disorders third edition (ICSD-3) for NT126
✓. Local residence for more than 3 months
✓. Willingness to follow the trial plan as scheduled

Exclusion criteria

✕. History of a clinically defined neurological or sleep disorders other than NT1
✕. Any psychiatric disorder involving a history of psychosis
✕. Any chronic condition affecting the ability to read or comprehend written instructions
✕. Any substances abuse within the past 12 months
✕. Pregnant or nursing
✕. Metallic implants or devices contraindicating tVNS

What they're measuring

maintenance of wakefulness test (MWT)

Timeframe: 12 weeks

Trial details

NCT IDNCT06241911

SponsorLiu Yonghong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More Narcolepsy Type 1 trials