An interventional study of MUSIC CARE® Standardized Music Listening and Neutral Spoken-Word Audiobook Control in Chronic Pain, Alzheimer Disease and Dementia, sponsored by Florida State University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Florida State University · Not applicable, Interventional, and Treatment
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.
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Florida State University is the lead sponsor of 249 studies on the registry; 47 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults with Alzheimer's Disease and Related Dementias (ADRD):
Caregivers:
Exclusion Criteria
Adults with ADRD:
Caregivers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this sequence will begin with a MUSIC CARE® session before proceeding through the remaining randomized listening conditions. Each participant will complete eight 30-minute sessions, consisting of two morning MUSIC CARE® sessions, two afternoon MUSIC CARE® sessions, two morning audiobook control sessions, and two afternoon audiobook control sessions. The order of subsequent conditions will follow the study's counterbalanced randomization schedule.
Behavioral: MUSIC CARE® Standardized Music Listening · Behavioral: Neutral Spoken-Word Audiobook Control
Participants assigned to this sequence will begin with a neutral spoken-word audiobook session before proceeding through the remaining randomized listening conditions. Each participant will complete eight 30-minute sessions, consisting of two morning MUSIC CARE® sessions, two afternoon MUSIC CARE® sessions, two morning audiobook control sessions, and two afternoon audiobook control sessions. The order of subsequent conditions will follow the study's counterbalanced randomization schedule.
Behavioral: MUSIC CARE® Standardized Music Listening · Behavioral: Neutral Spoken-Word Audiobook Control
MUSIC CARE® is a standardized digital music listening intervention that uses a U-sequence algorithm to structure instrumental music within the participant's preferred genre. Participants will listen for 30 minutes using study-provided headphones in their homes, with caregiver assistance and remote research staff supervision. Each participant will complete four MUSIC CARE® sessions, including two morning sessions between 9:00 AM and 11:00 AM and two afternoon sessions between 3:00 PM and 5:00 PM. The intervention will be delivered as part of a randomized, counterbalanced, within-subject crossover protocol.
The control intervention consists of neutral educational or documentary spoken-word audiobook passages without musical accompaniment, matched to MUSIC CARE® for listening duration and delivery format. Participants will listen for 30 minutes using study-provided headphones in their homes, with caregiver assistance and remote research staff supervision. Each participant will complete four audiobook control sessions, including two morning sessions between 9:00 AM and 11:00 AM and two afternoon sessions between 3:00 PM and 5:00 PM.
Recruitment of Eligible Participant and Caregiver Dyads
Recruitment feasibility will be assessed by the number of eligible participant and caregiver dyads enrolled relative to the target sample of 20 dyads. Each dyad consists of one adult with early-stage Alzheimer's disease and related dementias (ADRD) and chronic pain and one eligible adult caregiver. Recruitment will be summarized as the number of enrolled dyads and the percentage of target enrollment achieved, calculated as the number of enrolled dyads divided by 20, multiplied by 100.
Time frame: Up to 12 months (from initiation of recruitment through completion of enrollment).
Participant and Caregiver Retention
Retention will be assessed as the percentage of enrolled participant and caregiver dyads completing planned study procedures, including the intervention period and end-of-study assessments. The retention percentage will be calculated as the number of enrolled dyads completing study procedures divided by the total number of enrolled dyads, multiplied by 100.
Time frame: From enrollment through completion of study procedures, approximately 2 weeks per dyad.
Completion of Scheduled Home Listening Sessions
Intervention adherence will be measured as the percentage of scheduled home listening sessions completed by each adult participant with ADRD. Each participant is scheduled to complete eight 30-minute sessions, consisting of two morning MUSIC CARE® sessions, two afternoon MUSIC CARE® sessions, two morning audiobook control sessions, and two afternoon audiobook control sessions. Adherence will be calculated as the number of completed sessions divided by eight, multiplied by 100.
Time frame: Across eight scheduled home listening sessions over approximately 2 weeks per participant.
Acceptability of Caregiver-Assisted Home Listening Procedures
Acceptability of the home-based listening intervention and caregiver-assisted study procedures will be evaluated using study-specific information collected from participants with ADRD and their caregivers. The assessment will address experiences with listening sessions, caregiver assistance, equipment setup, remote supervision, and physiological monitoring. Available responses will be summarized descriptively to characterize the acceptability of completing these procedures in the home setting.
Time frame: During the home intervention period, approximately 2 weeks per dyad.
Percentage of Artifact-Free EEG Epochs During Home Sessions
EEG acquisition feasibility will be measured as the percentage of recorded EEG epochs retained as artifact-free and suitable for analysis after signal preprocessing and quality assessment. For each session, the percentage of artifact-free EEG epochs will be calculated as the number of usable epochs divided by the total number of recorded epochs, multiplied by 100. EEG will be acquired during five-minute eyes-closed resting periods before and after listening and continuously during the 30-minute listening intervention. At least 50% artifact-free epochs per session is the prespecified feasibility benchmark.
Time frame: Before, during, and after each of eight home listening sessions over approximately 2 weeks per participant.
Acquisition of Analyzable Heart Rate Variability Recordings
HRV data acquisition feasibility will be assessed by the completeness and analyzability of heart rate and RR interval recordings obtained using the Polar H10 sensor during home study sessions. Recordings will be evaluated for signal quality and suitability for deriving HRV indices following artifact screening. Data availability and analyzability will be summarized descriptively across scheduled resting and listening recording periods. No numerical HRV feasibility threshold is prespecified.
Time frame: During resting and listening recordings across eight home sessions over approximately 2 weeks per participant.
Change in Participant-Reported Pain Intensity
Pain intensity will be assessed using the participant-reported Numeric Rating Scale (NRS) immediately before and after each 30-minute listening session. Within-session change in pain intensity will be calculated as the post-session pain rating minus the pre-session pain rating, with negative values indicating reduced pain intensity. Changes will be examined across MUSIC CARE® and audiobook control conditions and morning versus afternoon delivery. Ratings will be obtained directly from participants with ADRD, without substituting caregiver proxy ratings.
Time frame: Immediately before and after each of eight 30-minute listening sessions over approximately 2 weeks per participant.
Change in Pain Interference Measured by the Brief Pain Inventory
Pain interference will be assessed using the Brief Pain Inventory Interference subscale (BPI-I) at baseline and study completion. The instrument evaluates the extent to which pain interferes with general activity, mood, walking ability, normal work, relationships with others, sleep, and enjoyment of life. Change in pain interference will be calculated as the study completion score minus the baseline score, with negative values indicating reduced pain-related interference.
Time frame: At baseline and study completion, approximately 2 weeks apart.
Change in Frontal Alpha Asymmetry.
Frontal alpha asymmetry (FAA) will be derived from electroencephalography (EEG) recorded with the X-trodes Smart Skin System M using the XTR EEG12 dry-electrode patch. After artifact removal, FAA will be calculated as ln(AF8 alpha power) minus ln(AF7 alpha power), using each participant's individual alpha frequency band. Higher values indicate relatively greater left than right frontal activity. For each session, the change in FAA from pre-session rest to the listening period, and from pre-session rest to post-session rest, will be calculated. Within-participant differences in these changes will be examined by listening type (MUSIC CARE® versus audiobook control), time of day (morning versus afternoon), and their interaction. Associations with participant-reported pain intensity, measured using the Numeric Rating Scale (NRS) before and after each session, will be explored.
Time frame: Five-minute rest before, 30-minute listening period, and five-minute rest after each of eight home sessions over two weeks.
Change in Frontal Theta Power.
Frontal theta power will be derived from EEG recorded with the X-trodes Smart Skin System M using the XTR EEG12 dry-electrode patch. After removal of blink, eye-movement, and muscle artifacts, theta power at AF7 and AF8 will be averaged and expressed as the natural logarithm of absolute power in each participant's individual theta frequency band (unit: ln µV²). For each session, the change in frontal theta power from pre-session rest to the listening period, and from pre-session rest to post-session rest, will be calculated. Within-participant differences in these changes will be examined by listening type (MUSIC CARE® versus audiobook control), time of day (morning versus afternoon), and their interaction. Associations with participant-reported pain intensity, measured using the Numeric Rating Scale (NRS) before and after each session, will be explored.
Time frame: Five-minute rest before, 30-minute listening period, and five-minute rest after each of eight home sessions over two weeks.
Change in High-Frequency Heart Rate Variability (HF-HRV)
High-frequency heart rate variability (HF-HRV) will be derived from RR intervals recorded with a Polar H10 chest-strap sensor. After artifact correction, HF-HRV will be calculated as the natural logarithm of spectral power in the 0.15-0.40 Hz band (unit: ln ms²), computed in five-minute windows. The listening-period value will be the mean of its six five-minute windows. Windows with more than 5% corrected beats will be excluded. For each session, the change in HF-HRV from pre-session rest to the listening period, and from pre-session rest to post-session rest, will be calculated. Within-participant differences in these changes will be examined by listening type (MUSIC CARE® versus audiobook control), time of day (morning versus afternoon), and their interaction. Associations with participant-reported pain intensity, measured using the Numeric Rating Scale (NRS) before and after each session, will be explored.
Time frame: Five-minute rest before, 30-minute listening period, and five-minute rest after each of eight home sessions over two weeks.
No study locations are listed for this record.
Plan to share: Undecided — The study will manage and share scientific data in accordance with the NIH Data Management and Sharing Policy and the Data Management and Sharing Plan applicable to this study. The specific scope and conditions for sharing deidentified individual participant data have not yet been finalized. Any future sharing will be consistent with participant consent, institutional requirements, and applicable privacy and confidentiality protections. Direct participant identifiers will not be shared.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.