Alzheimer Disease, Dementia, Music Therapy
Conditions
Keywords
Dementia, Alzheimer Disease, Brain stimulation, Music
Brief summary
This is a randomized, cross-over study to measure global and clinical impact and level of arousal in subjects suffering from moderate to severe Alzheimer's disease when exposed to emotionally impactful music compared to control intervention.
Detailed description
In partnership with the study partner (a person who spends 10 hours or more a week with the subject and can reliably report on the subject's condition), three tunes will be chosen for the purposes of the study. The tunes chosen will need to be related to a past meaningful, positive experience of the subject, as determined by the subject and the subject's study partner. The pieces will be restricted in duration to between 1.5 and 2 minutes each. A piece will be chosen at random and will be saved on a portable device, and subjects will be asked to listen to the melody using high quality, over-ear headphones. The total exposure time will be 10 minutes each hour over a three-hour period. The melody will be repeated as many times as necessary to complete the 10-minute period. The control intervention will involve listening to nature sounds at the same duration and administration scheme. Functional magnetic resonance imaging will be used to identify how brain networks are modulated via exposure to this music and how they associate with the clinical findings.
Interventions
BEHAVIORALPreferred Music
Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours
BEHAVIORALNature Sounds
Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours
Sponsors
National Endowment for the Arts, United States
American Association of Retired Persons
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Person of any sex/gender aged between 55 and 90 * Stated willingness to comply with all study procedures and availability for the duration of the study * In the opinion of the investigator, has an informant able and willing to provide accurate information about the participant (may be paid or unpaid caregiver) * Suffer from moderate to severe Alzheimer's disease as established by the study team using the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria for possible and probable Alzheimer's Disease * Diagnosis of Alzheimer's disease or other type of dementia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) * Mini Mental State Examination (MMSE) score of 5-20 * Subject is reported by the study partner to be able to listen to a minimum of 10 minutes of music and a sound in an uninterrupted manner.
Exclusion criteria
* Suffer from severe hearing impairment as reported by the informant * Presence of neuropsychiatric symptoms of dementia as determined by clinical observation by the Principal Investigator, including history of agitation and/or combative behavior. * Individuals who score ≥ 12 seconds on the Timed Up and Go (TUG) Test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days) | This is a 7-item score ranging from markedly worse to markedly improved. It is assessed by the study clinician who interviews both participant and makes an informed judgment how to incorporate their input. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days) | Participants will provide a self-assessed scoring of their level of arousal on a scale of 1-7 ranging from Feeling active, vital, alert, or wide awake to No longer fighting sleep, sleep onset soon; having dream-like thoughts. |
Countries
United States
Participant flow
Recruitment details
The PI contacted physicians in the Charleston, South Carolina area to inform them about the study and request patient referrals of potential participants. Once a referral was made, the potential participant was contacted by the PI via telephone, the study was described, and if the participant and study partner expressed interest in the study, the study coordinator scheduled them for a Screening Visit.
Pre-assignment details
No significant events in the study occured after participant enrollment and prior to assignment of participants to an arm or group.
Participants by arm
| Arm | Count |
|---|---|
| Preferred Music - Visit 1, Nature Sounds - Visit 2 Preferred Music: Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours
Nature Sounds: Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours | 5 |
| Nature Sounds - Visit 1, Preferred Music - Visit 2 Preferred Music: Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours
Nature Sounds: Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Preferred Music - Visit 1, Nature Sounds - Visit 2 | Nature Sounds - Visit 1, Preferred Music - Visit 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 3 / 5 | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
This is a 7-item score ranging from markedly worse to markedly improved. It is assessed by the study clinician who interviews both participant and makes an informed judgment how to incorporate their input.
Time frame: Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)
Population: All 10 participants were assessed after being exposed to preferred music (PM) and nature sounds (NS) and rated on the Clinical Global Impression of Change (CGIC).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Marked improvement - Rating 1 | 0 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Moderate improvement - Rating 1 | 5 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Minimal improvement - Rating 1 | 2 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | No change - Rating 1 | 1 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Minimal worsening - Rating 1 | 1 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Moderate worsening - Rating 1 | 1 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Marked worsening - Rating 1 | 0 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Marked improvement - Rating 2 | 0 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Moderate improvement - Rating 2 | 9 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Minimal Improvement - Rating 2 | 1 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | No Change - Rating 2 | 0 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Minimal worsening - Rating 2 | 0 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Moderate worsening - Rating 2 | 0 Participants |
| Preferred Music | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Marked worsening - Rating 2 | 0 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | No Change - Rating 2 | 2 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Marked improvement - Rating 1 | 0 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Marked improvement - Rating 2 | 0 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Moderate improvement - Rating 1 | 2 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Moderate worsening - Rating 2 | 4 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Minimal improvement - Rating 1 | 0 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Moderate improvement - Rating 2 | 2 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | No change - Rating 1 | 4 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Minimal worsening - Rating 2 | 2 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Minimal worsening - Rating 1 | 1 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Minimal Improvement - Rating 2 | 0 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Moderate worsening - Rating 1 | 3 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Marked worsening - Rating 2 | 0 Participants |
| Nature Sounds | Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) | Marked worsening - Rating 1 | 0 Participants |
Secondary
Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)
Participants will provide a self-assessed scoring of their level of arousal on a scale of 1-7 ranging from Feeling active, vital, alert, or wide awake to No longer fighting sleep, sleep onset soon; having dream-like thoughts.
Time frame: Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)
Population: All 10 participants were assessed after being exposed to preferred music (PM) and nature sounds (NS) and rated on the Stanford Sleepiness Scale (SSS).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 1 - Feeling active, vital, alert, or wide awake - Rating 1 | 3 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 2 - Functioning at high levels, but not at peak - Rating 1 | 1 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 3 - Awake, but relaxed; responsive, but not fully alert - Rating 1 | 5 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 4 - Somewhat foggy, let down - Rating 1 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 5 - Foggy; losing interest in staying awake; slowed down - Rating 1 | 1 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 6 - Sleepy, woozy, fighting sleep; prefer to lie down - Rating 1 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 7 - No longer fighting sleep; sleep onset soon - Rating 1 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | X - Asleep - Rating 1 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 1 - Feeling active, vital, alert, or wide awake - Rating 2 | 5 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 2 - Functioning at high levels, but not at peak - Rating 2 | 5 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 3 - Awake, but relaxed; responsive, but not fully alert - Rating 2 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 4 - Somewhat foggy, let down - Rating 2 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 5 - Foggy; losing interest in staying awake; slowed down - Rating 2 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 6 - Sleepy, woozy, fighting sleep; prefer to lie down - Rating 2 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 7 - No longer fighting sleep; sleep onset soon - Rating 2 | 0 Participants |
| Preferred Music | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | X - Asleep - Rating 2 | 0 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | X - Asleep - Rating 2 | 0 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 1 - Feeling active, vital, alert, or wide awake - Rating 1 | 1 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 1 - Feeling active, vital, alert, or wide awake - Rating 2 | 2 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 2 - Functioning at high levels, but not at peak - Rating 1 | 4 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 5 - Foggy; losing interest in staying awake; slowed down - Rating 2 | 0 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 3 - Awake, but relaxed; responsive, but not fully alert - Rating 1 | 2 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 2 - Functioning at high levels, but not at peak - Rating 2 | 1 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 4 - Somewhat foggy, let down - Rating 1 | 2 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 7 - No longer fighting sleep; sleep onset soon - Rating 2 | 0 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 5 - Foggy; losing interest in staying awake; slowed down - Rating 1 | 1 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 3 - Awake, but relaxed; responsive, but not fully alert - Rating 2 | 2 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 6 - Sleepy, woozy, fighting sleep; prefer to lie down - Rating 1 | 0 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 6 - Sleepy, woozy, fighting sleep; prefer to lie down - Rating 2 | 0 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 7 - No longer fighting sleep; sleep onset soon - Rating 1 | 0 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | 4 - Somewhat foggy, let down - Rating 2 | 5 Participants |
| Nature Sounds | Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) | X - Asleep - Rating 1 | 0 Participants |