Renal DialysisPhase 4NCT03997058
Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD
A Phase 4 study testing Auricular point pressure therapy and Oral estazolam medication in people with Renal Dialysis and Sleep Initiation and Maintenance Disorders, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Dialysis, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Auricular point pressure therapy and Oral estazolam medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzho University of Chinese Medicine
Guangzhou, Guangdong, 510405
About this study
Official title: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
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.
- Being tested
- Auricular point pressure therapy, Oral estazolam medication
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular point pressure therapyOther
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.
Oral estazolam medicationDrug
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 group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Auricular acupoint pressing group | Experimental | Not described Receives: Other: Auricular point pressure therapy |
| Oral estazolam group | Active comparator | Not described Receives: Drug: Oral estazolam medication |
| Combined treatment group | Active comparator | Not described Receives: Other: Auricular point pressure therapy; Drug: Oral estazolam medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index（PSQI）score
Measured: June 1, 2019 to June 1, 2021
Mortality rate
Measured: June 1, 2019 to June 1, 2021
Secondary outcomes (3)
Incidence of cardiovascular events
Measured: June 1, 2019 to June 1, 2021
Cerebrovascular accident rate
Measured: June 1, 2019 to June 1, 2021
Gastrointestinal bleeding rate
Measured: June 1, 2019 to June 1, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Mar 2019
- Primary completion1 Jun 2020
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Negative control group, auricular acupoint pressing group, estazolam group， combined treatment group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitao Tu, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997058
- Sponsor's protocol ID
- 20191114
- Status last verified
- Dec 2020
- First submitted
- 23 Jun 2019
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
- ClinicalTrials.gov ID
- NCT03997058
- Acronym / sponsor ID
- 20191114
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Negative control group, auricular acupoint pressing group, estazolam group， combined treatment group
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Auricular acupoint pressing group | Experimental | Other: Auricular point pressure therapy |
| Oral estazolam group | Active comparator | Drug: Oral estazolam medication |
| Combined treatment group | Active comparator | Other: Auricular point pressure therapy, Drug: Oral estazolam medication |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular point pressure therapyUse 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. | Other | Auricular acupoint pressing group, Combined treatment group |
| Oral estazolam medicationThe 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. | Drug | Combined treatment group, Oral estazolam group |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Auricular point pressure therapy and Oral estazolam medication in people with Renal Dialysis and Sleep Initiation and Maintenance Disorders, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh sleep quality index（PSQI）score (time frame: June 1, 2019 to June 1, 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.