Auricular Acupressure for Hemodialysis Patients With Insomnia (AAHDIN)
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ClinicalTrials.gov Identifier: NCT03015766 |
Recruitment Status :
Completed
First Posted : January 10, 2017
Last Update Posted : May 13, 2019
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Condition or disease | Intervention/treatment | Phase |
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Insomnia Chronic | Other: auricular acupressure therapy Other: sham auricular acupressure therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial |
Actual Study Start Date : | May 1, 2017 |
Actual Primary Completion Date : | October 1, 2018 |
Actual Study Completion Date : | May 1, 2019 |
Arm | Intervention/treatment |
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Experimental: Auricular acupressure therapy
Participants in the treatment group will received AAT on five active acupoints including Acup.1. Shen Men (Spiritual Gate, TF4), Acup.2. Jiao Gan (Sympathetic autonomic, AH6a), Acup.3. Xin (Heart, CO15), Acup.4. Pi Zhi Xia (Subcortex, AT4), Acup.5. Nei Fen Mi (Endocrine, CO18)
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Other: auricular acupressure therapy
Auricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.
Other Names:
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Sham Comparator: sham auricular acupressure therapy
Participants in the control group (SAA group) will receive auricular acupressure on five Helix points (HX 5-9), which were clearly remote from the inner ear area. These points have no evidence for insomnia management.
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Other: sham auricular acupressure therapy
The intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.
Other Name: sham AAT |
- clinical response rate [ Time Frame: at 8 weeks from baseline ]Response is defined as a reduction of Pittsburgh sleep quality index (PSQI) global score by 3 points and more according to literature review
- change of PSQI scores at the end of treatment [ Time Frame: change from baseline PSQI scores at 8 weeks ]PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
- change of PSQI scores at the first followup [ Time Frame: change from baseline PSQI scores at 12 weeks ]PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
- change of PSQI scores at the second followup [ Time Frame: change from baseline PSQI scores at 16 weeks ]PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
- change of PSQI scores at the third followup [ Time Frame: change from baseline PSQI scores at 20 weeks ]PSQI scores will include PSQI global score, and scores of each domain (i.e. sleep duration, sleep disturbance, sleep latency, day dysfunction, sleep efficiency, overall sleep quality and sleep medication).
- weekly dose of hypnotics [ Time Frame: Day 0 (baseline), at 8 weeks (the end of treatment), at 12 weeks (the first followup),at 16 weeks (the second followup) and at 20 weeks (the third followup) ]If participants required hypnotic agents during the study because of unbearable sleep disorders, they will be allowed to take hypnotics initiating from the minimum dose and encouraged to complete the trial. The weekly dose of hypnotic agents will be recorded.
- adverse events [ Time Frame: through study completion, an average of 20 weeks ]Adverse events throughout the treatment and follow-up periods, regardless of its relevance to the interventions, will be documented and dealt with by appropriate measures.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Aged 18~75 years
- On regular dialysis ( 2 - 3 sessions weekly, 4 hours each session, total weekly dialysis hours ≥ 10 hours) for more than 3 months (but less than 10 years)
- Insomnia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- Global score of PSQI > 7
- Informed consent.
Exclusion Criteria:
- Presence of co-morbidities including cancer, congestive heart failure, connective tissue disease and hematologic diseases;
- Inadequately dialyzed, indicating by urea clearance index (KT/V) < 1.20;
- Presence of severe physical symptoms such as bone pain, itchy skin, sleep apnea and restless legs which are obviously causative for insomnia; and weary condition caused by severe anemia (hemoglobin<60g/L) or malnutrition (serum albumin<30g/L).
- Infections of external ears or malformed ears.

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): NCT03015766
China, Guangdong | |
Guangzhou HEMC (Higher Education Mega Center) Hospital | |
Guangzhou, Guangdong, China, 510000 | |
Guangdong Provincial Hospital of Chinese Medicine | |
Guangzhou, Guangdong, China, 510120 | |
Guangzhou Hospital of Traditional Chinese Medicine | |
Guangzhou, Guangdong, China, 510130 | |
Guangzhou Charity Hospital | |
Guangzhou, Guangdong, China, 510370 | |
Wuyi Hospital of Traditional Chinese Medicine | |
Jiangsu Sheng, Guangdong, China, 529099 | |
Shenzhen Hospital of Traditional Chinese Medicine | |
Shebu, Guangdong, China, 518026 |
Principal Investigator: | Qizhan Lin, MD | Guangdong Provincial Hospital of Traditional Chinese Medicine |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Qizhan Lin, Professor, Guangdong Provincial Hospital of Traditional Chinese Medicine |
ClinicalTrials.gov Identifier: | NCT03015766 |
Other Study ID Numbers: |
YN2015MS25 |
First Posted: | January 10, 2017 Key Record Dates |
Last Update Posted: | May 13, 2019 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD including the demographic information, PSQI scores and drug use at baseline and 8,12,16,20 week from baseline of all participants will be shared. The data will be availbale at ResMan® Clinical Trial Management Public Platform, with the link http://www.medresman.org/uc/index.aspx |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
insomnia hemodialysis auricular acupressure randomized controlled trial |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |