Music Listening for Chronic Pain in Adults With Early-Stage Dementia
NCT07918534, Not applicable, Not yet recruiting, Florida State University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Music Listening for Chronic Pain in Adults With Early-Stage Dementia | ClinicalTrials.gov |
| NCT number | NCT07918534 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Florida State University | ClinicalTrials.gov |
| Conditions | Chronic Pain, Alzheimer Disease, Dementia | ClinicalTrials.gov |
| Interventions | MUSIC CARE® Standardized Music Listening, Neutral Spoken-Word Audiobook Control | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recruitment of Eligible Participant and Caregiver Dyads | Up to 12 months (from initiation of recruitment through completion of enrollment). | 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. | ClinicalTrials.gov |
| Primary | Participant and Caregiver Retention | From enrollment through completion of study procedures, approximately 2 weeks per dyad. | 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. | ClinicalTrials.gov |
| Primary | Completion of Scheduled Home Listening Sessions | Across eight scheduled home listening sessions over approximately 2 weeks per participant. | 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. | ClinicalTrials.gov |
| Primary | Acceptability of Caregiver-Assisted Home Listening Procedures | During the home intervention period, approximately 2 weeks per dyad. | 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. | ClinicalTrials.gov |
| Primary | 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. | 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. | ClinicalTrials.gov |
| Primary | Acquisition of Analyzable Heart Rate Variability Recordings | During resting and listening recordings across eight home sessions over approximately 2 weeks per participant. | 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. | ClinicalTrials.gov |
| Secondary | Change in Participant-Reported Pain Intensity | Immediately before and after each of eight 30-minute listening sessions over approximately 2 weeks per participant. | 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. | ClinicalTrials.gov |
| Secondary | Change in Pain Interference Measured by the Brief Pain Inventory | At baseline and study completion, approximately 2 weeks apart. | 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. | ClinicalTrials.gov |
| Secondary | Change in Frontal Alpha Asymmetry. | Five-minute rest before, 30-minute listening period, and five-minute rest after each of eight home sessions over two weeks. | 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. | ClinicalTrials.gov |
| Secondary | Change in Frontal Theta Power. | Five-minute rest before, 30-minute listening period, and five-minute rest after each of eight home sessions over two weeks. | 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. | ClinicalTrials.gov |
| Secondary | Change in High-Frequency Heart Rate Variability (HF-HRV) | Five-minute rest before, 30-minute listening period, and five-minute rest after each of eight home sessions over two weeks. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U24AG084436 | Research Network to Accelerate Mechanistic Studies of Music for Dementia (RN-MusD) | JOHNSON, JULENE K | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE ON AGING | 2023 to 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)