Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD

Phase 4

• Conditions: Renal Dialysis; Sleep Initiation and Maintenance Disorders
• Interventions: Other: Auricular point pressure therapy; Drug: Oral estazolam medication

• Registration Number: NCT03997058
• Lead Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Brief Summary

Maintenance hemodialysis (MHD) is one of the most important treatments for patients with end-stage renal failure. Studies have found that insomnia is widespread in MHD patients, affecting their quality of life. Auricular acupoint pressing is an effective traditional Chinese medicine treatment for insomnia. This study compared the effects of auricular acupoint pressing and oral estazolam on insomnia in patients with MHD, and evaluated the possibility of auricular acupoint pressing to reduce the incidence of adverse events by improving insomnia in patients with MHD, and to explore the insomnia of MHD patients treated with TCM characteristics. The role and efficacy provide a basis for the treatment of sleep disorders by Chinese medicine.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-06-23
• Study First Submitted QC: 2019-06-23
• Study First Posted: 2019-06-25
• Primary Completion: 2020-06-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-12
• Last Update Posted: 2020-12-16
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.Age 18-90 years old，received maintenance hemodialysis treatment for more than 1 year, no history of surgical trauma, infection, trauma in the past 3 months; 2.the current condition is stable, the heart function is grade I, no limb paralysis, speech disadvantages and other sequelae； 3.Informed consent volunteer to participate in this experiment.

Exclusion Criteria

1. At present, dialysis is inadequate, water and sodium retention is severe;
2. combined with severe cardiovascular disease, sequelae of cerebral infarction or history of cerebral hemorrhage, history of COPD, history of myasthenia gravis, history of angle-closure glaucoma, blood system disease, mental system disease or other systemic The disease can not be matched with the experimenter;
3. poor compliance or poor medical attitude;
4. severe hearing or vision loss, or a very low level of education, can not match the experiment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined treatment group	Auricular point pressure therapy	-
Auricular acupoint pressing group	Auricular point pressure therapy	-
Oral estazolam group	Oral estazolam medication	-
Combined treatment group	Oral estazolam medication	-

Primary Outcome Measures

Name	Time	Method
Mortality rate	June 1, 2019 to June 1, 2021
Pittsburgh sleep quality index（PSQI）score	June 1, 2019 to June 1, 2021

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal bleeding rate	June 1, 2019 to June 1, 2021
Incidence of cardiovascular events	June 1, 2019 to June 1, 2021
Cerebrovascular accident rate	June 1, 2019 to June 1, 2021

Trial Locations

Locations (1)

The First Affiliated Hospital of Guangzho University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China