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

Guangzhou University of Chinese Medicine

Status and phase: Unknown; Phase 4

Conditions: Sleep Initiation and Maintenance Disorders; Renal Dialysis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03997058

20191114

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 4 patient groups

Control group

No Intervention group

Auricular acupoint pressing group

Experimental group

Treatment:

Other: Auricular point pressure therapy

Oral estazolam group

Active Comparator group

Treatment:

Drug: Oral estazolam medication

Combined treatment group

Active Comparator group

Treatment:

Drug: Oral estazolam medication

Other: Auricular point pressure therapy