Clinical trial NCT03997058: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Renal Dialysis
Sleep Initiation and Maintenance Disorders
Lead sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Negative control group, auricular acupoint pressing group, estazolam group， combined treatment group
Primary purpose: TREATMENT

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.


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:

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.

Primary outcomes:
measure: Pittsburgh sleep quality index（PSQI）score
timeFrame: June 1, 2019 to June 1, 2021
measure: Mortality rate
timeFrame: June 1, 2019 to June 1, 2021
Secondary outcomes:
measure: Incidence of cardiovascular events
timeFrame: June 1, 2019 to June 1, 2021
measure: Cerebrovascular accident rate
timeFrame: June 1, 2019 to June 1, 2021
measure: Gastrointestinal bleeding rate
timeFrame: June 1, 2019 to June 1, 2021
Other outcomes:
measure: Hypersensitive C-reactive protein concentration
timeFrame: June 1, 2019 to June 1, 2021
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzho University of Chinese Medicine
state: Guangdong
Study officials:
References: