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

NCT03997058 | Unknown Phase 4 DMC

• 1 other identifier: 20191114
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dialysis; Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (2)

• Pittsburgh sleep quality index（PSQI）score

  June 1, 2019 to June 1, 2021

• Mortality rate

  June 1, 2019 to June 1, 2021

Secondary Outcomes (3)

• 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 Outcomes (1)

• Hypersensitive C-reactive protein concentration

  June 1, 2019 to June 1, 2021

Study Arms (4)

Control group

NO INTERVENTION

Auricular acupoint pressing group

EXPERIMENTAL

Other: Auricular point pressure therapy

Oral estazolam group

ACTIVE COMPARATOR

Drug: Oral estazolam medication

Combined treatment group

ACTIVE COMPARATOR

Other: Auricular point pressure therapy; Drug: Oral estazolam medication

Interventions

Auricular point pressure therapy OTHER

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.

Auricular acupoint pressing group; Combined treatment group

Oral estazolam medication DRUG

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.

Combined treatment group; Oral estazolam group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• At present, dialysis is inadequate, water and sodium retention is severe;
• 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;
• poor compliance or poor medical attitude;
• severe hearing or vision loss, or a very low level of education, can not match the experiment.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Guangzho University of Chinese Medicine

Guangzhou, Guangdong, 510405, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Negative control group, auricular acupoint pressing group, estazolam group， combined treatment group

Study Record Dates

• First Submitted: June 23, 2019
• First Posted: June 25, 2019
• Study Start: March 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: January 1, 2021
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

CN (1)