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Electroacupuncture versus sham electroacupuncture for insomnia in end-stage renal disease undergoing maintenance hemodialysis: study protocol for a pilot randomized controlled trial

Electroacupuncture versus sham electroacupuncture for insomnia in end-stage renal disease undergoing maintenance hemodialysis: study protocol for a pilot randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071814
Enrollment
Unknown
Registered
2023-05-25
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

insomnia in end-stage renal disease undergoing hemodialysis

Interventions

Sponsors

Beijing Dongcheng First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, male or female 2. Diagnosed with end-stage renal disease and chronic insomnia based on abovementioned diagnosis criteria 3. Insomnia Severity Index (ISI) >= 15 4. Maintenance hemodialysis treatment >= 3 months with stable condition 5. Agree to use zopiclone as rescue medicine 6. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Renal transplant patients 2. Having hemorrhagic disease, neurological disease, metabolic disease, hematopoietic system disease, infectious disease or other severe acute or chronic organic diseases 3. History of long-term use of sleeping pills before hemodialysis treatment 4. Having taken sleeping pills within 2 weeks before the first hemodialysis treatment 5. Having unstable toxuria complications such as water-electrolyte and acid-base disturbances, calcium and phosphorus metabolism disorders, cardiac insufficiency 6. Having undergone acupuncture therapy within 3 months 7. Having mental disorders or severe cognitive disorders 8. Pregnant or breastfeeding women 9. Having participated in other clinical trials within 3 months 10. Unable to cooperate or unwilling to comply with all study requirements 11. Cardiac pacemaker, metal allergy, or needle phobia

Design outcomes

Primary

MeasureTime frame
effective rate of sleep improvement;

Secondary

MeasureTime frame
Insomnia Severity Idex;Pittsburgh sleep quality index;12-Item Short Form Survey;Fatigue severity scale;Sleep diary;Ambulatory blood pressure;

Countries

China

Contacts

Public ContactLu Anming

Beijing Dongcheng First People's Hospital

xu_xiaobai1990@sina.com+86 130 5152 6173

Outcome results

None listed

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