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Auricular Acupressure for Hemodialysis Patients With Insomnia (AAHDIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015766
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Qizhan Lin, Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary:
Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. A randomized controlled clinical trial is planned to evaluate the effect and safety of AAT in MHD patients with insomnia.

Condition or disease Intervention/treatment Phase
Insomnia Chronic Other: auricular acupressure therapy Other: sham auricular acupressure therapy Not Applicable

Detailed Description:
Insomnia, a worldwide health problem, is much more frequently complained in maintenance hemodialysis (MHD) patients and impairs their quality of life and long term outcome. Hypnotic sedative agents are often reluctantly prescribed with doses mounting up. Patients are concerned about drug dependence and drug-related adverse effects. As a non-drug therapy, auricular acupressure therapy (AAT) is attractive to both patients and practitioners and is widely used to treat many conditions in China. The investigators had been applying AAT for MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. Therefore, the investigators aimed to perform a randomized controlled clinical trial in MHD patients with insomnia to evaluate the effect and safety of AAT.

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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
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)
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:
  • auricular acupressure
  • ear acupressure

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.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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
Criteria

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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Principal Investigator: Qizhan Lin, MD Guangdong Provincial Hospital of Traditional Chinese Medicine
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qizhan Lin, Guangdong Provincial Hospital of Traditional Chinese Medicine:
insomnia
hemodialysis
auricular acupressure
randomized controlled trial
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders