Clinical trial NCT03015766: Auricular Acupressure for Hemodialysis Patients With Insomnia
Official title: Auricular Acupressure for Hemodialysis Patients With Insomnia: Study Protocol for a Multi-centre Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Keywords: insomnia
hemodialysis
auricular acupressure
randomized controlled trial
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: clinical response rate
timeFrame: at 8 weeks from baseline
Secondary outcomes:
measure: change of PSQI scores at the end of treatment
timeFrame: change from baseline PSQI scores at 8 weeks
measure: change of PSQI scores at the first followup
timeFrame: change from baseline PSQI scores at 12 weeks
measure: change of PSQI scores at the second followup
timeFrame: change from baseline PSQI scores at 16 weeks
measure: change of PSQI scores at the third followup
timeFrame: change from baseline PSQI scores at 20 weeks
measure: weekly dose of hypnotics
timeFrame: 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)
measure: adverse events
timeFrame: through study completion, an average of 20 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou HEMC (Higher Education Mega Center) Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Hospital of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Charity Hospital
state: Guangdong
city: Jiangsu Sheng
country: China
facility: Wuyi Hospital of Traditional Chinese Medicine
state: Guangdong
city: Shebu
country: China
facility: Shenzhen Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Qizhan Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.