search
Back to results

Auricular Acupressure for Hemodialysis Patients With Insomnia (AAHDIN)

Primary Purpose

Insomnia Chronic

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
auricular acupressure therapy
sham auricular acupressure therapy
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Chronic focused on measuring insomnia, hemodialysis, auricular acupressure, randomized controlled trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangzhou HEMC (Higher Education Mega Center) Hospital
  • Guangdong Provincial Hospital of Chinese Medicine
  • Guangzhou Hospital of Traditional Chinese Medicine
  • Guangzhou Charity Hospital
  • Wuyi Hospital of Traditional Chinese Medicine
  • Shenzhen Hospital of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Auricular acupressure therapy

sham auricular acupressure therapy

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

clinical response rate
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

change of PSQI scores at the end of treatment
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
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
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
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
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
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.

Full Information

First Posted
December 22, 2016
Last Updated
May 9, 2019
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03015766
Brief Title
Auricular Acupressure for Hemodialysis Patients With Insomnia
Acronym
AAHDIN
Official Title
Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic
Keywords
insomnia, hemodialysis, auricular acupressure, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auricular acupressure therapy
Arm Type
Experimental
Arm Description
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)
Arm Title
sham auricular acupressure therapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
auricular acupressure therapy
Other Intervention Name(s)
auricular acupressure, ear acupressure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham auricular acupressure therapy
Other Intervention Name(s)
sham AAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical response rate
Description
Response is defined as a reduction of Pittsburgh sleep quality index (PSQI) global score by 3 points and more according to literature review
Time Frame
at 8 weeks from baseline
Secondary Outcome Measure Information:
Title
change of PSQI scores at the end of treatment
Description
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).
Time Frame
change from baseline PSQI scores at 8 weeks
Title
change of PSQI scores at the first followup
Description
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).
Time Frame
change from baseline PSQI scores at 12 weeks
Title
change of PSQI scores at the second followup
Description
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).
Time Frame
change from baseline PSQI scores at 16 weeks
Title
change of PSQI scores at the third followup
Description
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).
Time Frame
change from baseline PSQI scores at 20 weeks
Title
weekly dose of hypnotics
Description
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.
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)
Title
adverse events
Description
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.
Time Frame
through study completion, an average of 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qizhan Lin, MD
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou HEMC (Higher Education Mega Center) Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Guangzhou Hospital of Traditional Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510130
Country
China
Facility Name
Guangzhou Charity Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China
Facility Name
Wuyi Hospital of Traditional Chinese Medicine
City
Jiangsu Sheng
State/Province
Guangdong
ZIP/Postal Code
529099
Country
China
Facility Name
Shenzhen Hospital of Traditional Chinese Medicine
City
Shebu
State/Province
Guangdong
ZIP/Postal Code
518026
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
25874938
Citation
Zou C, Yang L, Wu Y, Su G, Chen S, Guo X, Wu X, Liu X, Lin Q. Auricular acupressure on specific points for hemodialysis patients with insomnia: a pilot randomized controlled trial. PLoS One. 2015 Apr 15;10(4):e0122724. doi: 10.1371/journal.pone.0122724. eCollection 2015.
Results Reference
result
PubMed Identifier
24571603
Citation
Wu Y, Zou C, Liu X, Wu X, Lin Q. Auricular acupressure helps improve sleep quality for severe insomnia in maintenance hemodialysis patients: a pilot study. J Altern Complement Med. 2014 May;20(5):356-63. doi: 10.1089/acm.2013.0319. Epub 2014 Feb 26.
Results Reference
result
PubMed Identifier
35426736
Citation
Wu Y, Yang L, Zhong Z, Wu X, He Z, Ma H, Cai C, Li Y, Wu X, Fu B, Chen X, Wang L, Zhao D, Meng X, Qi A, Yang A, Li L, Liu X, Zou C, Lin Q. Auricular Acupressure for Hemodialysis Patients with Insomnia: A Multicenter Double-Blind Randomized Sham-Controlled Trial. J Integr Complement Med. 2022 Apr;28(4):339-348. doi: 10.1089/jicm.2021.0332. Epub 2022 Jan 13.
Results Reference
derived
PubMed Identifier
29514705
Citation
Wu Y, Yang L, Li L, Wu X, Zhong Z, He Z, Ma H, Wang L, Lu Z, Cai C, Zhao D, Meng X, Qi A, Yang A, Su G, Guo X, Liu X, Zou C, Lin Q. Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial. Trials. 2018 Mar 7;19(1):171. doi: 10.1186/s13063-018-2546-2.
Results Reference
derived
Links:
URL
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0122724
Description
previously finished pilot RCT
URL
http://online.liebertpub.com/doi/abs/10.1089/acm.2013.0319
Description
observational study on auricular acupressure

Learn more about this trial

Auricular Acupressure for Hemodialysis Patients With Insomnia

We'll reach out to this number within 24 hrs