Back to resultsObservation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD
Primary Purpose
Renal Dialysis, Sleep Initiation and Maintenance Disorders
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Auricular point pressure therapy
Oral estazolam medication
Sponsored by
About this trial
This is an interventional treatment trial for Renal Dialysis
Eligibility Criteria
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:
- 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.
Sites / Locations
- The First Affiliated Hospital of Guangzho University of Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Active Comparator
Active Comparator
Arm Label
Control group
Auricular acupoint pressing group
Oral estazolam group
Combined treatment group
Arm Description
Outcomes
Primary Outcome Measures
Pittsburgh sleep quality index（PSQI）score
Mortality rate
Secondary Outcome Measures
Incidence of cardiovascular events
Cerebrovascular accident rate
Gastrointestinal bleeding rate
Full Information
NCT ID
NCT03997058
First Posted
June 23, 2019
Last Updated
December 12, 2020
Sponsor
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03997058
Brief Title
Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD
Official Title
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Dialysis, Sleep Initiation and Maintenance Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Negative control group, auricular acupoint pressing group, estazolam group， combined treatment group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Title
Auricular acupoint pressing group
Arm Type
Experimental
Arm Title
Oral estazolam group
Arm Type
Active Comparator
Arm Title
Combined treatment group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Auricular point pressure therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral estazolam medication
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pittsburgh sleep quality index（PSQI）score
Time Frame
June 1, 2019 to June 1, 2021
Title
Mortality rate
Time Frame
June 1, 2019 to June 1, 2021
Secondary Outcome Measure Information:
Title
Incidence of cardiovascular events
Time Frame
June 1, 2019 to June 1, 2021
Title
Cerebrovascular accident rate
Time Frame
June 1, 2019 to June 1, 2021
Title
Gastrointestinal bleeding rate
Time Frame
June 1, 2019 to June 1, 2021
Other Pre-specified Outcome Measures:
Title
Hypersensitive C-reactive protein concentration
Time Frame
June 1, 2019 to June 1, 2021
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzho University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
12. IPD Sharing Statement
Learn more about this trial
Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD
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