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

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Initiation and Maintenance Disorders; Renal Dialysis
• Intervention / Treatment: Other: Auricular point pressure therapy; Drug: Oral estazolam medication

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510405
      • The First Affiliated Hospital of Guangzho University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Auricular acupoint pressing group	Other: Auricular point pressure therapy; Use a hard and smooth pill to adhere to the center of the 0.7×0.7cm tape. Hold the puncture clip on the part of the ear which is selected, and give appropriate pressure (揉) to make the patient have heat, hemp, Swelling and painful feeling; patients with sputum press 3-5 times a day, each time 1-2 minutes per hole, and must be pressed once every 15-30 minutes before going to bed every night. Press the point pressure method (press the ear point with a fingertip and press it loosely, each interval is 0.5 seconds. It is better for the patient to feel the swelling and slightly heavy tingling, and the force should not be too heavy. Generally, each time the hole can be pressed 27 times. Each time one side of the ear is selected, the two ear points are used alternately, staying in the summer for 1-3 days, and staying in the winter for 3-7 days.It is not appropriate to have local inflammation of the auricle, frostbite or surface skin ulceration.
Active Comparator: Oral estazolam group	Drug: Oral estazolam medication; The first dose was started from 0.5mg, qn, and taken at 30min-1h before going to bed. If the dose is not effective, gradually increase the amount to 2mg, qn. If the patient has drug-induced liver damage and respiratory depression, it is necessary to stop the drug immediately. Hemorrhoids avoid drinking alcohol during medication.
Active Comparator: Combined treatment group	Other: Auricular point pressure therapy; Use a hard and smooth pill to adhere to the center of the 0.7×0.7cm tape. Hold the puncture clip on the part of the ear which is selected, and give appropriate pressure (揉) to make the patient have heat, hemp, Swelling and painful feeling; patients with sputum press 3-5 times a day, each time 1-2 minutes per hole, and must be pressed once every 15-30 minutes before going to bed every night. Press the point pressure method (press the ear point with a fingertip and press it loosely, each interval is 0.5 seconds. It is better for the patient to feel the swelling and slightly heavy tingling, and the force should not be too heavy. Generally, each time the hole can be pressed 27 times. Each time one side of the ear is selected, the two ear points are used alternately, staying in the summer for 1-3 days, and staying in the winter for 3-7 days.It is not appropriate to have local inflammation of the auricle, frostbite or surface skin ulceration.; Drug: Oral estazolam medication; The first dose was started from 0.5mg, qn, and taken at 30min-1h before going to bed. If the dose is not effective, gradually increase the amount to 2mg, qn. If the patient has drug-induced liver damage and respiratory depression, it is necessary to stop the drug immediately. Hemorrhoids avoid drinking alcohol during medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pittsburgh sleep quality index（PSQI）score	June 1, 2019 to June 1, 2021
Mortality rate	June 1, 2019 to June 1, 2021

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of cardiovascular events	June 1, 2019 to June 1, 2021
Cerebrovascular accident rate	June 1, 2019 to June 1, 2021
Gastrointestinal bleeding rate	June 1, 2019 to June 1, 2021

Other Outcome Measures

Outcome Measure	Time Frame
Hypersensitive C-reactive protein concentration	June 1, 2019 to June 1, 2021

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: June 23, 2019
• First Submitted That Met QC Criteria: June 23, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 12, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Estazolam
• Other Study ID Numbers: 20191114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No