Auricular Acupressure for Hemodialysis Patients With Insomnia

NCT03015766 | Completed

• 1 other identifier: YN2015MS25
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

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.

Conditions

Insomnia Chronic

Keywords

insomnia; hemodialysis; auricular acupressure; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

  at 8 weeks from baseline

Secondary Outcomes (6)

• change of PSQI scores at the end of treatment

  change from baseline PSQI scores at 8 weeks

• change of PSQI scores at the first followup

  change from baseline PSQI scores at 12 weeks

• change of PSQI scores at the second followup

  change from baseline PSQI scores at 16 weeks

• change of PSQI scores at the third followup

  change from baseline PSQI scores at 20 weeks

• weekly dose of hypnotics

  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)

Study Arms (2)

Auricular acupressure therapy

EXPERIMENTAL

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

sham auricular acupressure therapy

SHAM COMPARATOR

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

Interventions

auricular acupressure therapy OTHER

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.

Also known as: auricular acupressure, ear acupressure

Auricular acupressure therapy

sham auricular acupressure therapy OTHER

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.

Also known as: sham AAT

sham auricular acupressure therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (6)

Guangzhou HEMC (Higher Education Mega Center) Hospital

Guangzhou, Guangdong, 510000, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Guangzhou Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510130, China

Location

Guangzhou Charity Hospital

Guangzhou, Guangdong, 510370, China

Location

Wuyi Hospital of Traditional Chinese Medicine

Jiangsu Sheng, Guangdong, 529099, China

Location

Shenzhen Hospital of Traditional Chinese Medicine

Shebu, Guangdong, 518026, China

Location

Related Publications (4)

• 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.

  PMID: 25874938 RESULT

• 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.

  PMID: 24571603 RESULT

• 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.

  PMID: 35426736 DERIVED

• 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.

  PMID: 29514705 DERIVED

Related Links

• previously finished pilot RCT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Qizhan Lin, MD

  Guangdong Provincial Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 10, 2017
• Study Start: May 1, 2017
• Primary Completion: October 1, 2018
• Study Completion: May 1, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)