Abstract
BackgroundPatients 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/designThe 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.DiscussionThis 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 registrationClinicalTrials.gov, Identifier: NCT03015766. Registered on 22 December 2016.
Highlights
Patients on maintenance hemodialysis (MHD) frequently complain of insomnia
This paper describes the rationale and design of a double-blind randomized controlled trial (RCT) that aims to determine the efficacy and safety of auricular acupressure therapy (AAT) for insomnia of hemodialysis patients
In a pilot randomized controlled trial (RCT), we found that AAT on specific points with an appropriate rationale yielded a higher response rate in Pittsburgh Sleep Quality Index (PSQI) score improvement than that on sham points (62.5% vs. 32.3%, χ2 = 5.77, P = 0.02) [22]
Summary
Patients on maintenance hemodialysis (MHD) frequently complain of insomnia. Poor sleep quality impairs their quality of life and adversely affects long-term outcome. The proposed randomized controlled trial (RCT) will evaluate the efficacy and safety of AAT for improvement of sleep quality in MHD patients with insomnia. Sleep disorders, such as insomnia, restless leg syndrome, sleep apnea and excessive daytime sleepiness, are common in patients with end-stage renal disease (ESRD), especially in those receiving dialysis [1]. CKD comorbidity (e.g., diabetes) and CKD-related complications (e.g., uremia, anemia and hyperparathyroidism) are all recognized factors [5, 11, 12] Somatic symptoms, such as pruritus, bone pain and arthralgia, are related to impaired sleep quality in dialysis patients [13]
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