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The Effects of Music on ANS and Anxiety in Healthy Elderly and Persons With SCD

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Music
White noise
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring music, anxiety, autonomic nervous system, subjective cognition decline

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • able to read and write Mandarin
  • the scores of the Montreal Cognitive Assessment (MoCA) ≥ 24

Exclusion Criteria:

  • cognitive status was affected by psychic problems, neurological disease or other conditions
  • people with auditory and visual impairments
  • people with obesity (BMI ≥ 27) or diabetes mellitus.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SCD subjects

Healthy controls

Arm Description

Patients were diagnosed with subjective cognition decline and referred by neurologists.

Voluntary healthy elderly recruited from the community.

Outcomes

Primary Outcome Measures

Heart rate variability
Heart activity was transformed into low- and high-frequency power components, which represented sympathetic and parasympathetic system activities respectively. It is recorded by skin conductance sensors wearing on the 2nd to 4th finger. These sensors connect to ProComp2™ Biofeedback System to collect biofeedback data. The data is further calibrated and analyzed by CardioPro Infiniti software.
Skin conductance
Electrodermal activity related to sympathetic system response (sweating). It is recorded by skin conductance sensors wearing on the 2nd to 4th finger. These sensors connect to ProComp2™ Biofeedback System to collect biofeedback data. The data is further calibrated and analyzed by CardioPro Infiniti software.
Visual Analogue Scale of Anxiety
Participants reports their immediately subjective anxiety levels.

Secondary Outcome Measures

Chinese version of state-trait anxiety inventory-trait version
A self-report regards to participants' usual emotional status and personal characteristic based on a 4-point Likert scale and consists of 20 questions. People who get higher scores are considered having more anxious personality.

Full Information

First Posted
November 13, 2019
Last Updated
January 17, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04177160
Brief Title
The Effects of Music on ANS and Anxiety in Healthy Elderly and Persons With SCD
Official Title
The Effects of Music on Autonomic Nervous System and Anxiety in Healthy Elderly and Persons With Subjective Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
November 13, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Subjective cognition decline (SCD) is considered as a risk factor of dementia and associates not only with further cognition deterioration but with a higher anxiety level. Anxiety may lead to decreasing cognitive function and negative impacts on the well-being and quality of life. To avoid these consequences, reducing anxiety is an important step to treat SCD. To ease anxious emotions, music has been viewed as an effective, safe and easy alternative to medication. Thus, the purpose of this study is to investigate the effects of music on reducing the anxiety of the healthy elderly and SCD and further to compare the anxiety level between SCD and healthy controls.
Detailed Description
Single subject pretest-posttest design was used. 12 SCD subjects was recruited from the memory clinic and 12 healthy controls from the community. The anxiety level was assessed both by self-reports (State-Trait Anxiety Inventory and Visual Analogue Scale of Anxiety) and by objective measurements related to autonomic nervous system activities (heart rate variability and electrodermal activity). The participants underwent a memory task to induce anxiety. Next, preferred music and white noise were provided in random order. The anxiety level and the effects of music intervention between SCD and healthy controls will be further compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
music, anxiety, autonomic nervous system, subjective cognition decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCD subjects
Arm Type
Experimental
Arm Description
Patients were diagnosed with subjective cognition decline and referred by neurologists.
Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
Voluntary healthy elderly recruited from the community.
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
Subjects sit still and listen to preferred music for 5 minutes.
Intervention Type
Behavioral
Intervention Name(s)
White noise
Intervention Description
Subjects sit still and listen to white noise for 5 minutes.
Primary Outcome Measure Information:
Title
Heart rate variability
Description
Heart activity was transformed into low- and high-frequency power components, which represented sympathetic and parasympathetic system activities respectively. It is recorded by skin conductance sensors wearing on the 2nd to 4th finger. These sensors connect to ProComp2™ Biofeedback System to collect biofeedback data. The data is further calibrated and analyzed by CardioPro Infiniti software.
Time Frame
45 minutes
Title
Skin conductance
Description
Electrodermal activity related to sympathetic system response (sweating). It is recorded by skin conductance sensors wearing on the 2nd to 4th finger. These sensors connect to ProComp2™ Biofeedback System to collect biofeedback data. The data is further calibrated and analyzed by CardioPro Infiniti software.
Time Frame
45 minutes
Title
Visual Analogue Scale of Anxiety
Description
Participants reports their immediately subjective anxiety levels.
Time Frame
After each stimulus task and intervention: on the 10th, 15th, 20th, 25th, 35th and 40th minute.
Secondary Outcome Measure Information:
Title
Chinese version of state-trait anxiety inventory-trait version
Description
A self-report regards to participants' usual emotional status and personal characteristic based on a 4-point Likert scale and consists of 20 questions. People who get higher scores are considered having more anxious personality.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: able to read and write Mandarin the scores of the Montreal Cognitive Assessment (MoCA) ≥ 24 Exclusion Criteria: cognitive status was affected by psychic problems, neurological disease or other conditions people with auditory and visual impairments people with obesity (BMI ≥ 27) or diabetes mellitus.
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24798886
Citation
Jessen F, Amariglio RE, van Boxtel M, Breteler M, Ceccaldi M, Chetelat G, Dubois B, Dufouil C, Ellis KA, van der Flier WM, Glodzik L, van Harten AC, de Leon MJ, McHugh P, Mielke MM, Molinuevo JL, Mosconi L, Osorio RS, Perrotin A, Petersen RC, Rabin LA, Rami L, Reisberg B, Rentz DM, Sachdev PS, de la Sayette V, Saykin AJ, Scheltens P, Shulman MB, Slavin MJ, Sperling RA, Stewart R, Uspenskaya O, Vellas B, Visser PJ, Wagner M; Subjective Cognitive Decline Initiative (SCD-I) Working Group. A conceptual framework for research on subjective cognitive decline in preclinical Alzheimer's disease. Alzheimers Dement. 2014 Nov;10(6):844-52. doi: 10.1016/j.jalz.2014.01.001. Epub 2014 May 3.
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The Effects of Music on ANS and Anxiety in Healthy Elderly and Persons With SCD

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