Music Listening for Chronic Pain in Adults With Early-Stage Dementia

Chronic pain is common among individuals living with Alzheimer's disease and related dementias (ADRD) and is frequently underrecognized because of cognitive and communication difficulties. Untreated pain may contribute to behavioral and psychological symptoms, functional limitations, and caregiver burden. Accessible, home-based nonpharmacologic interventions may provide opportunities to improve pain management in this population. Music-based interventions engage neural pathways involved in attention, affective regulation, and pain processing, as well as autonomic processes associated with physiological regulation. However, the neurophysiological mechanisms underlying music-related pain modulation in individuals with ADRD remain insufficiently understood. Limited evidence is available regarding the feasibility of collecting reliable neural and autonomic measurements during caregiver-assisted music listening at home or whether these physiological responses vary by time of day. This exploratory mechanistic pilot study will evaluate MUSIC CARE®, a standardized digital music listening intervention that uses a U-sequence algorithm to deliver structured instrumental music within a participant-selected preferred genre. The study will examine the feasibility of intervention delivery and the acquisition of analyzable electroencephalography (EEG) and heart rate variability (HRV) recordings in home environments. Exploratory analyses will investigate candidate physiological biomarkers of music-related pain modulation and their associations with participant-reported pain. The study will enroll 20 community-dwelling adults aged 55 years or older with early-stage ADRD and chronic pain, each paired with an eligible adult caregiver, for a total of 20 participant and caregiver dyads. Caregivers will be separately consented and trained to assist with intervention delivery, EEG electrode and HRV sensor placement, and participant safety monitoring. Study procedures will be conducted in participants' homes under remote supervision by trained research personnel. Adults with ADRD must be able to provide their own informed consent and communicate their pain ratings. Caregivers will assist with procedures but will not provide substitute proxy pain ratings. The study will use a randomized, counterbalanced, within-subject crossover design. Each participant with ADRD will complete eight listening sessions across four conditions: morning MUSIC CARE®, afternoon MUSIC CARE®, morning neutral spoken-word audiobook control, and afternoon audiobook control. Each condition will be repeated twice. Sessions will occur once daily over approximately two consecutive Monday through Friday weeks, with two weekdays reserved for rescheduling when necessary. Morning sessions will occur between 9:00 AM and 11:00 AM, and afternoon sessions between 3:00 PM and 5:00 PM. Each listening session will last 30 minutes. MUSIC CARE® uses a standardized U-sequence algorithm to structure instrumental music within the participant's preferred genre. The control condition will consist of neutral educational or documentary spoken-word audiobook passages without music, matched for listening duration and delivery format. EEG will be recorded using the X-trodes Smart Skin System M. Each session will include five minutes of eyes-closed resting EEG before and after the 30-minute listening period, with continuous EEG recording during listening. Heart rate and RR intervals will be recorded using the Polar H10 sensor during resting and listening periods to support HRV analysis. Participant-reported pain intensity will be assessed immediately before and after each listening session using the Numeric Rating Scale (NRS). Pain interference will be measured at baseline and study completion using the Brief Pain Inventory Interference subscale (BPI-I). The primary objective is to establish the feasibility of caregiver-assisted, home-based music listening and physiological monitoring in adults with early-stage ADRD. Primary feasibility outcomes will include recruitment, retention, intervention adherence, acceptability, and acquisition of analyzable EEG and HRV recordings. EEG signal acquisition feasibility will be evaluated by the proportion of artifact-free EEG epochs retained following preprocessing, with at least 50% artifact-free epochs per session serving as a pragmatic feasibility benchmark. Secondary and exploratory outcomes will include participant-reported pain intensity, pain interference, frontal alpha asymmetry, frontal midline theta power, and high-frequency HRV. Frontal alpha asymmetry and frontal midline theta will be examined as candidate EEG biomarkers of affective and attentional regulation, while high-frequency HRV will be examined as an indicator of cardiac parasympathetic regulation. Exploratory statistical analyses will use mixed-effects models to assess within-participant differences associated with listening condition (MUSIC CARE® versus audiobook control), time of day (morning versus afternoon), and their interaction, with consideration of repeated measurements and session order. Associations between EEG and HRV biomarkers and participant-reported pain will also be explored. Analyses will include available analyzable observations without requiring participants to meet feasibility benchmarks before inclusion in exploratory mechanistic analyses. This pilot study is designed to establish feasibility and generate preliminary mechanistic evidence rather than provide a definitive test of clinical efficacy. Findings will inform the refinement of home-based intervention procedures, selection of candidate physiological biomarkers, and design of future clinical trials of music-based pain management in individuals with ADRD.