NCT07918534Not yet recruiting
Music Listening for Chronic Pain in Adults With Early-Stage Dementia
Mechanistic Biomarkers of Music-Induced Analgesia in Early-Stage ADRD
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 30 Mar 2027
- Primary completion date
- 29 Jan 2028
- Lead sponsor
- Florida State University
- Diseases
- Alzheimer disease
- NCT number
- NCT07918534
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 30 Mar 2027 to the primary completion date, 29 Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe uncorrected hearing loss that would interfere with participation in the listening conditions.
- Neurological conditions unrelated to ADRD that could confound EEG measurement, including a history of seizures, major brain injury, or neurosurgery.
- Psychiatric or medical instability that would interfere with safe participation in the study.
- Dermatological conditions that would interfere with use of the EEG equipment or headphones.
Age
- Younger than 18 years.
Other
- Adults with ADRD:
- Inability to provide informed consent personally.
- Caregivers:
- Unable to provide informed consent or complete study procedures in English.
- Unable to provide the assistance required for caregiver-assisted home study procedures.
Who the study is looking for
- Adults with Alzheimer's Disease and Related Dementias (ADRD):
- Age 55 years or older.
- Early-stage ADRD, defined as a Clinical Dementia Rating Sum of Boxes (CDR-SB) score of 1.0 to 9.0.
- Chronic pain lasting at least three months.
- Average daily pain intensity of at least 30 on a 0 to 100 Numeric Rating Scale (NRS).
- Stable medication regimen for at least four weeks before enrollment.
- Available to participate in weekday study sessions.
- Reliable internet access for remote study procedures.
- Has an eligible adult caregiver who can assist with study procedures.
- Able to provide informed consent personally.
- Able to complete informed consent and study procedures in English.
- Caregivers:
- Age 18 years or older.
- Lives with the participant with ADRD or has daily in-person contact with the participant.
- Available to assist with study setup, monitoring, adherence, and study procedures.
- Able to provide informed consent.
- Able to complete informed consent and study procedures in English.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.