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

Halpin, SJ, Xing, L, Greenwood, DC, Tang, NKY, Trujillo-Barreto, NJ ORCID: https://orcid.org/0000-0001-6581-7503, Brown, C, Jones, AKP, O'Connor, RJ, Casson, AJ and Sivan, M (2025) Pre-sleep alpha brain entrainment by audio or visual stimulation for chronic widespread pain and sleep disturbance: a randomised crossover feasibility trial. The Journal of Pain, 31. 105393. ISSN 1526-5900

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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. ClinicalTrials.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.