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

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ClinicalTrials.gov Identifier: NCT03997058
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Haitao Tu, 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.

Condition or disease Intervention/treatment Phase
Renal Dialysis Sleep Initiation and Maintenance Disorders Other: Auricular point pressure therapy Drug: Oral estazolam medication Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Negative control group, auricular acupoint pressing group, estazolam group, combined treatment group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Estazolam

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.




Primary Outcome Measures :
  1. Pittsburgh sleep quality index(PSQI)score [ Time Frame: June 1, 2019 to June 1, 2021 ]
  2. Mortality rate [ Time Frame: June 1, 2019 to June 1, 2021 ]

Secondary Outcome Measures :
  1. Incidence of cardiovascular events [ Time Frame: June 1, 2019 to June 1, 2021 ]
  2. Cerebrovascular accident rate [ Time Frame: June 1, 2019 to June 1, 2021 ]
  3. Gastrointestinal bleeding rate [ Time Frame: June 1, 2019 to June 1, 2021 ]

Other Outcome Measures:
  1. Hypersensitive C-reactive protein concentration [ Time Frame: June 1, 2019 to June 1, 2021 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997058


Contacts
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Contact: TAO HAI TU, Master's degree 086-13828483741 020410@gzucm.edu.cn

Locations
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China, Guangdong
The First Affiliated Hospital of Guangzho University of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510405
Contact: Tao Hai Tu, master    086-13828483741    020410@gzucm.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

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Responsible Party: Haitao Tu, Principal Investigator, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03997058    
Other Study ID Numbers: 20191114
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Estazolam
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action