Clinical efficacy and safety of rTMS combined with bright light therapy for sleep disorders in patients with Alzheimer's disease: study protocol for a randomized controlled study
Abstract
Abstract Background Sleep disorders are highly prevalent in Alzheimer's disease (AD) and significantly contribute to cognitive decline and reduced quality of life. While current pharmacotherapies offer limited efficacy and pose significant risks, there remains an urgent need for safe and effective non-pharmacological alternatives. Although both repetitive transcranial magnetic stimulation (rTMS) and bright light therapy (BLT) have shown promise as monotherapies, their combined therapeutic effects remain insufficiently explored. This study therefore aims to evaluate the efficacy and safety of combined rTMS-BLT intervention for AD-related sleep disturbances and to investigate the underlying neurobiological mechanisms. Methods This prospective, randomized, open-label, controlled, single-center trial will enroll 80 AD patients with sleep disorders. Participants will be randomly assigned to one of four groups: combined rTMS-BLT, single-rTMS, single-BLT, or control intervention, receiving treatment for 4 weeks (5 sessions / week). Assessments will be conducted at baseline, immediately post-intervention (week 4), and at follow-up (week 8). The primary outcome is the change in the Pittsburgh Sleep Quality Index (ΔPSQI). Secondary outcomes include sleep parameters assessed by polysomnography and actigraphy parameters, serum melatonin and reactive oxygen species levels, excitatory/inhibitory neurotransmitter levels measured via encephalofluctuography, and adverse events. Data will be…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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