Pre-sleep alpha brain entrainment by audio or visual stimulation for chronic widespread pain and sleep disturbance: A randomised crossover feasibility trial

Abstract

Home-based neuromodulation is a potentially scalable option to assist with management of chronic widespread pain. Since sleep disturbance is closely interrelated with chronic pain, especially in conditions such as fibromyalgia, targeting symptoms pre-sleep could enhance treatment efficacy. Alpha entrainment is a neuromodulatory technique to improve pain which can be applied via a smartphone programme using 10 Hz stimulation through flickering light or binaural beats. The aim of this study was to assess feasibility, mechanistic effects on alpha spectral power during pre-sleep entrainment and indicate the potential effect on symptoms. Adults with fibromyalgia participated in two weeks of active and sham stimulation at home pre-sleep in a randomised, balanced sequence, with a one-week washout, in a two-period crossover design. Sham stimulation was non-rhythmic but otherwise perceptually similar, and participants and experimenters were masked to sequence. Effect of stimulation was assessed with daily symptom and sleep diary, nightly wearable EEG monitoring (Dreem 3 headband) and actigraphy. Alpha spectral power was enhanced during active compared to sham stimulation, substantiating the entrainment effect under pre-sleep, home based conditions. Pain at night (0-10 scale) decreased with active stimulation compared to sham: difference -0.53 (95 % CI -0.81 to -0.25, P<0.001). Sleep quality (0-5 scale) improved with active stimulation compared to sham: difference +0.39 (95 % CI 0.15 to 0.64, P= 0.002). Pre-sleep sensory alpha entrainment with home-based EEG monitoring in fibromyalgia is feasible with potentially helpful effects on pain and sleep without significant unwanted effects. Longer duration study in larger trials is warranted.

Gov registration id: NCT05699837 PERSPECTIVE: This study applies a non-invasive pre-sleep neuromodulatory technique in individuals with fibromyalgia. It demonstrates the feasibility of the approach, verifies the mechanism of sensory alpha entrainment in this real-life environment and indicates self-reported improvements to pain and sleep quality compared to a sham stimulation. These findings can help refine interventions and design larger trials.

Data availability: Data will be made available on reasonable request.

Keywords: Alpha power; Entrainment; Fibromyalgia; Neuromodulation; Nociplastic pain.