Auricular Acupressure for Hemodialysis Patients With Insomnia

Insomnia Chronic Clinical Trial

— AAHDIN  

Official title:

Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015766
• Other study ID #: YN2015MS25
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: May 2019
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
China	Guangzhou Charity Hospital	Guangzhou	Guangdong
China	Guangzhou HEMC (Higher Education Mega Center) Hospital	Guangzhou	Guangdong
China	Guangzhou Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong
China	Wuyi Hospital of Traditional Chinese Medicine	Jiangsu Sheng	Guangdong
China	Shenzhen Hospital of Traditional Chinese Medicine	Shebu	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 from baseline PSQI scores at 8 weeks
Secondary	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 from baseline PSQI scores at 12 weeks
Secondary	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 from baseline PSQI scores at 16 weeks
Secondary	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).	change from baseline PSQI scores at 20 weeks
Secondary	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.	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)
Secondary	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.	through study completion, an average of 20 weeks

External Links

•   observational study on auricular acupressure
•   previously finished pilot RCT