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Observation of clinical effect and brain mechanism of transcutaneous auricularvagus nerve stimulation combined with six-character slow breathing in treatment of insomnia

Observation of clinical effect and brain mechanism of transcutaneous auricularvagus nerve stimulation combined with six-character slow breathing in treatment of insomnia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000027
Enrollment
Unknown
Registered
2025-01-07
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Insomnia

Interventions

Health interventions:taVNS stimulation combined slow pace brathing
Control group:taVNS stimulation
Healthy subjects:taVNS stimulation
Combined treatment group:taVNS stimulation combined slow pace brathing

Sponsors

Experimental Research Center China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.insomnia patient 1) Those who meet the diagnostic criteria for insomnia; 2) Aged 18-70 years old right-handed; (3) Pittsburg sleep quality index (PSQI) score =8 points and duration > 3 months; 2.Health control (1) physical health no serious heart brain liver kidney and other organ diseases; (2) age 18~ 70 years old; (3) mental mental illness such as psychosis cerebrovascular disease cognitive impairment and intracranial astrology; (4) no chronic disease somatic disease and the history of brain organic disease: no sleep disease (5) the cognitive function is normal and can understand and complete the test process. (6) non-nuclear magnetic resonance examination of contraindications;

Exclusion criteria

Exclusion criteria: 1. Insomniacs 1) Patients with severe physical diseases organic brain diseases and serious mental disorders; (2) Patients with severe primary diseases acute diseases infectious diseases and malignant tumors; 3) Sleep disorders caused by secondary insomnia poor sleep hygiene or other reasons 4)HAMD-17 scores > 17 points and HAMA-14 scores > 14 points; (5) Patients with magnetic resonance imaging (MRI) contraindications; 6) Pregnant and lactating women need to use tools to help them walk 2. Healthy subjects (1) Have stayed up late or worked shift in the past two weeks; (2) Patients with a history of headache or body pain; (4) No history of chronic diseases physical diseases and organic brain diseases: no sleep disorders (5) Pregnant women and breastfeeding nearly 3 months of planning;

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Hamilton Anxiety Scale;Hamilton Depression Scale;Insomnia Severity Index;Fatigue Severity Scale;Epworth Sleepiness Scale;Dynamic brain network; resting Brian function;inflammatory factor;

Countries

China

Contacts

Public ContactDai Jingang

Experimental Research Center China Academy of Chinese Medical Sciences

zhongyidai@163.com13391858902

Outcome results

None listed

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