Trial Outcomes & Findings for Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY (NCT NCT05309369)
NCT ID: NCT05309369
Last Updated: 2025-09-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)
Results posted on
2025-09-09
Participant Flow
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.
No significant events in the study occured after participant enrollment and prior to assignment of participants to an arm or group.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention (1 Week)
STARTED
|
5
|
5
|
|
First Intervention (1 Week)
COMPLETED
|
5
|
5
|
|
First Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
5
|
5
|
|
Second Intervention (1 Week)
COMPLETED
|
5
|
5
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY
Baseline characteristics by cohort
| Measure |
Preferred Music - Visit 1, Nature Sounds - Visit 2
n=5 Participants
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
|
Nature Sounds - Visit 1, Preferred Music - Visit 2
n=5 Participants
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
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Preferred Music
n=10 Participants
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
n=10 Participants
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
|
|---|---|---|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Minimal improvement - Rating 1
|
2 Participants
|
0 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Moderate worsening - Rating 1
|
1 Participants
|
3 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Minimal worsening - Rating 2
|
0 Participants
|
2 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Marked improvement - Rating 1
|
0 Participants
|
0 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Moderate improvement - Rating 1
|
5 Participants
|
2 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
No change - Rating 1
|
1 Participants
|
4 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Minimal worsening - Rating 1
|
1 Participants
|
1 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Marked worsening - Rating 1
|
0 Participants
|
0 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Marked improvement - Rating 2
|
0 Participants
|
0 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Moderate improvement - Rating 2
|
9 Participants
|
2 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Minimal Improvement - Rating 2
|
1 Participants
|
0 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
No Change - Rating 2
|
0 Participants
|
2 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Moderate worsening - Rating 2
|
0 Participants
|
4 Participants
|
|
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Marked worsening - Rating 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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).
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".
Outcome measures
| Measure |
Preferred Music
n=10 Participants
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
n=10 Participants
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
|
|---|---|---|
|
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
|
1 Participants
|
|
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
|
4 Participants
|
|
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
|
2 Participants
|
|
Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)
4 - Somewhat foggy, let down - Rating 1
|
0 Participants
|
2 Participants
|
|
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
|
1 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)
X - Asleep - Rating 1
|
0 Participants
|
0 Participants
|
|
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
|
2 Participants
|
|
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
|
1 Participants
|
|
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
|
2 Participants
|
|
Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)
4 - Somewhat foggy, let down - Rating 2
|
0 Participants
|
5 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
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
|
0 Participants
|
|
Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)
X - Asleep - Rating 2
|
0 Participants
|
0 Participants
|
Adverse Events
Preferred Music - Visit 1, Nature Sounds - Visit 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Nature Sounds - Visit 1, Preferred Music - Visit 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preferred Music - Visit 1, Nature Sounds - Visit 2
n=5 participants at risk
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
|
Nature Sounds - Visit 1, Preferred Music - Visit 2
n=5 participants at risk
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
|
|---|---|---|
|
General disorders
Fall
|
40.0%
2/5 • 5 weeks
Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.
|
0.00%
0/5 • 5 weeks
Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.
|
|
General disorders
Arm Abrasion
|
20.0%
1/5 • 5 weeks
Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.
|
0.00%
0/5 • 5 weeks
Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.
|
|
General disorders
Muscle Strain
|
0.00%
0/5 • 5 weeks
Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.
|
20.0%
1/5 • 5 weeks
Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.
|
|
General disorders
Common cold
|
0.00%
0/5 • 5 weeks
Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.
|
20.0%
1/5 • 5 weeks
Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place