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出境医 / 临床实验 / Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD

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

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.

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

Study Design
Layout table for study information
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 : March 1, 2019
Actual Primary Completion Date : June 1, 2020
Estimated Study Completion Date : January 1, 2021
Arms and Interventions
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.
Outcome Measures
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 ]

Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
China, Guangdong
The First Affiliated Hospital of Guangzho University of Chinese Medicine
Guangzhou, Guangdong, China, 510405
Sponsors and Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Tracking Information
First Submitted Date  ICMJE June 23, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date December 16, 2020
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2019)
  • Pittsburgh sleep quality index（PSQI）score [ Time Frame: June 1, 2019 to June 1, 2021 ]
  • Mortality rate [ Time Frame: June 1, 2019 to June 1, 2021 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2019)
  • Incidence of cardiovascular events [ Time Frame: June 1, 2019 to June 1, 2021 ]
  • Cerebrovascular accident rate [ Time Frame: June 1, 2019 to June 1, 2021 ]
  • Gastrointestinal bleeding rate [ Time Frame: June 1, 2019 to June 1, 2021 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 23, 2019) 		Hypersensitive C-reactive protein concentration [ Time Frame: June 1, 2019 to June 1, 2021 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD
Official Title  ICMJE The First Affiliated Hospital of Guangzhou University of 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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Renal Dialysis
  • Sleep Initiation and Maintenance Disorders
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • No Intervention: Control group
  • Experimental: Auricular acupoint pressing group
    Intervention: Other: Auricular point pressure therapy
  • Active Comparator: Oral estazolam group
    Intervention: Drug: Oral estazolam medication
  • Active Comparator: Combined treatment group
    Interventions:
    • Other: Auricular point pressure therapy
    • Drug: Oral estazolam medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 23, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03997058
Other Study ID Numbers  ICMJE 20191114
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Haitao Tu, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Study Sponsor  ICMJE The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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