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Transcutaneous vagus nerve stimulation at auricular concha for insomnia: basic and clinical research

Transcutaneous vagus nerve stimulation at auricular concha for insomnia: basic and clinical research

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-15007374
Enrollment
Unknown
Registered
2015-11-11
Start date
2015-12-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary insomnia

Interventions

ta-VNS group:ta-VNS
tn-VNS group:tn-VNS

Sponsors

Institute of acupuncture and moxibustion
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. DSM-V will be used for the diagnosis of sleep disorders: (1) The main problem is difficult to fall asleep, sleeping maintenance difficulty characterized by frequent night awakenings or difficulty falling asleep at least once a month; (2) Obvious trouble or obstacles in social contact, work, education, behavior or other important aspects induced by sleep disturbances (or relevant daytime fatigue); (3) Sleep disorders do not occure at narcolepsy, breathing-Related Sleep disorder and circadian rhythm sleep disorder onset period; (4) nsomnia cannot be explained by other sleep disorders and out of the course of other sleep disorders (e.g. narcolepsy, breathing-related sleep disorders, sleep-wake rhythm disorders and parasomnias); (5) Sleep difficulty is not induced by physiological effect of substance abuse. 2. Patients aged between 18-70 years; 3. Patients who can understand the content of scales and cooperate with the treatment.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Patients with severe primary diseases that involves the heart, brain, liver, kidney and hematopoietic system, or other acute diseases, contagions and malignancies; 3. Patients with sleep disorders induced by inadequate sleep hygiene; 4. Patients who cannot withdraw relevant medicines as required during the period of treatment.

Design outcomes

Primary

MeasureTime frame
PSQI;PSG;melatonin in plasma;

Secondary

MeasureTime frame
ESS;FSS;HAMD;HAMA;SF-36;HRV;fMRI;

Countries

China

Contacts

Public ContactRong Peijing
drrongpj@163.com+86 13718482149

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026