Annals of medicine · 2025
Electroacupuncture versus sham for insomnia in patients undergoing maintenance hemodialysis: study protocol for a pilot randomized controlled trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Lu Anming, Wang Mina, Jiang Nan, Liu Huilin, Gao Ying, Wang Tong, Xu Xiaobai, Li Bin
Аннотация
BACKGROUND: Insomnia causes severe health problems and poor quality of life in patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis (MHD). Conventional therapies are limited due to the poor availability and opaque evidence, and electroacupuncture (EA) is considered an alternative for improving insomnia in patients with ESRD undergoing MHD.
METHODS: This is a study protocol for a pilot randomized, sham-controlled, single-center, clinical trial. A total of 60 patients with insomnia in ESRD undergoing MHD will be randomly assigned to treatment group (EA, 3 sessions per week for 4 weeks), or sham group (sham EA, 3 sessions per week for 4 weeks) in a 1:1 ratio. Participants will complete the trial by visiting the research center at Week 8 for a follow-up assessment. The primary outcome is the response rate: the proportion of patients achieving a minimal clinically important difference, which is defined as ≥7 points on insomnia severity index (ISI) at Week 4 compared with baseline. Secondary outcomes include sleep diary, ISI, pittsburgh sleep quality index (PSQI), short form health survey-12 (SF-12), fatigue severity scale (FSS), 24-Hour ambulatory blood pressure, and plasma levels of C-reactive protein (CRP) and D-Dimer.
DISCUSSION: This is the first standardized protocol investigating the efficacy and safety of EA for patients with ESRD undergoing MHD. This trial may provide evidence for clinical application of EA for patients with ESRD undergoing MHD.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (registered number: ChiCTR2300071814).
METHODS: This is a study protocol for a pilot randomized, sham-controlled, single-center, clinical trial. A total of 60 patients with insomnia in ESRD undergoing MHD will be randomly assigned to treatment group (EA, 3 sessions per week for 4 weeks), or sham group (sham EA, 3 sessions per week for 4 weeks) in a 1:1 ratio. Participants will complete the trial by visiting the research center at Week 8 for a follow-up assessment. The primary outcome is the response rate: the proportion of patients achieving a minimal clinically important difference, which is defined as ≥7 points on insomnia severity index (ISI) at Week 4 compared with baseline. Secondary outcomes include sleep diary, ISI, pittsburgh sleep quality index (PSQI), short form health survey-12 (SF-12), fatigue severity scale (FSS), 24-Hour ambulatory blood pressure, and plasma levels of C-reactive protein (CRP) and D-Dimer.
DISCUSSION: This is the first standardized protocol investigating the efficacy and safety of EA for patients with ESRD undergoing MHD. This trial may provide evidence for clinical application of EA for patients with ESRD undergoing MHD.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (registered number: ChiCTR2300071814).