Abstract
Background
Patients on maintenance hemodialysis (MHD) frequently complain of insomnia. Poor sleep quality impairs their quality of life and adversely affects long-term outcome. Previously we applied auricular acupressure therapy (AAT) for MHD patients with insomnia and yielded favorable results. AAT probably improves sleep quality by stimulating the vagus nerve and inhibiting sympathetic overactivity. However, the efficacy of AAT for insomnia in this population is still lacking. The proposed randomized controlled trial (RCT) will evaluate the efficacy and safety of AAT for improvement of sleep quality in MHD patients with insomnia.
Methods/design
The proposed study is a multi-center, double-blind (participants and assessors), parallel-group RCT. A total of 112 participants with insomnia will be recruited from six hemodialysis centers in Guangzhou, China, and randomly allocated in a 1:1 ratio to receive auricular acupressure on either active points (AA group) or control points (points irrelevant to insomnia management, SAA group). The treatment will last for 8 weeks prior to a follow-up period of 12 weeks. Evaluation by blinded assessors at baseline, at 8 weeks (end of treatment) as well as at 4-week, 8-week and 12-week follow-ups (after intervention) will include Pittsburgh Sleep Quality Index (PSQI) scores and average weekly dose of hypnotics. The primary endpoint is clinical response rate (percentage of participants who reach a reduction of PSQI global score ≥ 3 in each group) at 8 weeks from baseline. Secondary endpoints include the changes in PSQI scores over time from baseline, as well as the changes in weekly dose of hypnotics.
Discussion
This paper describes the rationale and design of a double-blind RCT that aims to determine the efficacy and safety of AAT for insomnia of hemodialysis patients. If successful, this project will provide evidence of the efficacy and safety of AAT for insomnia of hemodialysis patients.
Trial registration
ClinicalTrials.gov, Identifier: NCT03015766. Registered on 22 December 2016.
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Details
1 Guangdong Provincial Hospital of Chinese Medicine, Hemodialysis Department, Guangzhou, People’s Republic of China (GRID:grid.413402.0); Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, People’s Republic of China (GRID:grid.411866.c) (ISNI:0000 0000 8848 7685)
2 Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, People’s Republic of China (GRID:grid.411866.c) (ISNI:0000 0000 8848 7685)
3 Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, People’s Republic of China (GRID:grid.411866.c) (ISNI:0000 0000 8848 7685); Guangzhou Charity Hospital, Hemodialysis Department, Guangzhou, People’s Republic of China (GRID:grid.411866.c)
4 Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, People’s Republic of China (GRID:grid.411866.c) (ISNI:0000 0000 8848 7685); Guangzhou HEMC (Higher Education Mega Center) Hospital, Hemodialysis Department, Guangzhou, People’s Republic of China (GRID:grid.411866.c)
5 Guangzhou Hospital of Traditional Chinese Medicine, Hemodialysis Department, Guangzhou, People’s Republic of China (GRID:grid.440211.2)
6 Shenzhen Hospital of Traditional Chinese Medicine, Hemodialysis Department, Shenzhen, People’s Republic of China (GRID:grid.440211.2)
7 Wuyi Hospital of Traditional Chinese Medicine, Hemodialysis Department, Jiangmen, People’s Republic of China (GRID:grid.440211.2)
8 Guangdong Provincial Hospital of Chinese Medicine, Hemodialysis Department, Guangzhou, People’s Republic of China (GRID:grid.413402.0); Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, People’s Republic of China (GRID:grid.411866.c) (ISNI:0000 0000 8848 7685); Guangdong Provincial Academy of Chinese Medical Sciences, Evidence-based Medicine and Clinical Research Service Group, Guangzhou, People’s Republic of China (GRID:grid.411866.c)
9 Guangdong Provincial Hospital of Chinese Medicine, Hemodialysis Department, Guangzhou, People’s Republic of China (GRID:grid.413402.0)