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To evaluate the efficacy and central mechanism of transcutaneous auricular vagus nerve stimulation in the treatment of sleep disorder in patients with end-stage renal disease and maintenance hemodialysis based on fMRI

To evaluate the efficacy and central mechanism of transcutaneous auricular vagus nerve stimulation in the treatment of sleep disorder in patients with end-stage renal disease and maintenance hemodialysis based on fMRI

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045271
Enrollment
Unknown
Registered
2021-04-10
Start date
2021-04-09
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

sleep disorder in patients with end-stage renal disease and maintenance hemodialysis

Interventions

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with end-stage renal disease (ESRD) maintenance hemodialysis with sleep disturbances: 1.All patients met the internationally recognized guidelines for chronic kidney disease developed by the American Kidney Foundation and were diagnosed by the following criteria: glomerular filtration rate <15mL/min/1.73m22) 2.ESRD patients received regular HD treatment and their condition was relatively stable; 3.No history of kidney transplantation or acute renal failure; 4.Meet the diagnostic criteria for sleep disorders; 5.<= 18 years old <= 80 years old, willing to participate in this study, and signed the informed consent, can cooperate; 6.No contraindication of MRI examination. End-stage renal disease maintenance hemodialysis patients without sleep disorders: all but 4).

Exclusion criteria

Exclusion criteria: Patients with end-stage renal disease and maintenance hemodialysis: 1. Patients with mental disorders, long-term use of antipsychotic drugs or dependence on drug sleep-aid therapy; 2. Complicated with serious complications, such as severe heart failure, acute pulmonary edema, severe infection, tumor and other diseases; 3. Dementia, Parkinson's disease or other neurodegenerative diseases; 4. Cranial magnetic resonance examination indicated intracranial cerebrovascular disease, tumor and other organic lesions; 5. Those who cannot complete the clinical scale test; 6. Patients with contraindication to MRI examination; 7. History of trauma.

Design outcomes

Primary

MeasureTime frame
PSQI;

Secondary

MeasureTime frame
MMSE;SDS;SAS;COMPASS-31;HRV;Functional magnetic resonance imaging index (ALFF/fALFF/ReHo/FC/DTI/ASL/ICA/complex networks/SVM/brain structure index, etc.);ISI;ESS;SF-36;PROMIS;FS14;

Countries

China

Contacts

Public ContactLiu Bo

Department of Radiology, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine

lbgdhtcm@163.com+86 13570112883

Outcome results

None listed

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