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

Registry record from ClinicalTrials.gov (NCT07918534). This is a study registration, not published results. Lead sponsor: Florida State University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Chronic Pain, Alzheimer Disease, Dementia. Interventions: BEHAVIORAL: MUSIC CARE® Standardized Music Listening; BEHAVIORAL: Neutral Spoken-Word Audiobook Control. Primary outcome measures: Recruitment of Eligible Participant and Caregiver Dyads , Up to 12 months (from initiation of recruitment through completion of enrollment).; Participant and Caregiver Retention , From enrollment through completion of study procedures, approximately 2 weeks per dyad.; Completion of Scheduled Home Listening Sessions , Across eight scheduled home listening sessions over approximately 2 weeks per participant.; Acceptability of Caregiver-Assisted Home Listening Procedures , During the home intervention period, approximately 2 weeks per dyad.; Percentage of Artifact-Free EEG Epochs During Home Sessions , Before, during, and after each of eight home listening sessions over approximately 2 weeks per participant.; Acquisition of Analyzable Heart Rate Variability Recordings , During resting and listening recordings across eight home sessions over approximately 2 weeks per participant.. Brief summary: Chronic pain is common among people living with Alzheimer's disease and related dementias (ADRD) and can negatively affect daily functioning and quality of life. Music listening may help manage pain, but researchers do not fully understand how music influences brain activity and the body's physiological responses in people with dementia. This exploratory pilot study will examine whether a standardized music listening intervention can be delivered successfully at home with caregiver assistance. It will also investigate how music listening affects brain activity, heart rate variability, and participant-reported pain, including whether responses differ between morning and afternoon sessions. The study will enroll 20 community-dwelling adults aged 55 years or older with early-stage ADRD and chronic pain, each supported by an eligible adult caregiver. Using a randomized, counterbalanced, within-subject crossover design, each adult with ADRD will complete eight home-based listening sessions across four conditions: morning MUSIC CARE®, afternoon MUSIC CARE®, morning audiobook control, and afternoon audiobook control. Each condition will be repeated twice over approximately two weeks. During each session, brain activity will be measured using electroencephalography (EEG), and heart rate variability (HRV) will be recorded using wearable sensors. Participants will report their pain intensity immediately before and after listening. The primary outcomes will assess recruitment, retention, intervention adherence, acceptability, and the feasibility of obtaining usable EEG and HRV recordings at home. Secondary exploratory outcomes will examine pain intensity, pain interference, frontal alpha asymmetry, frontal midline theta power, and high-frequency HRV. Findings will help researchers understand the feasibility and potential mechanisms of music-based pain modulation in ADRD and inform future clinical trials of home-based music interventions.