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

The Effects of Music on Autonomic Nervous System and Anxiety in Healthy Elderly and Persons With Subjective Cognitive Decline

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Music; Behavioral: White noise

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCD subjects; Patients were diagnosed with subjective cognition decline and referred by neurologists.	Behavioral: Music; Subjects sit still and listen to preferred music for 5 minutes.; Behavioral: White noise; Subjects sit still and listen to white noise for 5 minutes.
Experimental: Healthy controls; Voluntary healthy elderly recruited from the community.	Behavioral: Music; Subjects sit still and listen to preferred music for 5 minutes.; Behavioral: White noise; Subjects sit still and listen to white noise for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	45 minutes
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.	45 minutes
Visual Analogue Scale of Anxiety	Participants reports their immediately subjective anxiety levels.	After each stimulus task and intervention: on the 10th, 15th, 20th, 25th, 35th and 40th minute.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Actual): November 13, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: anxiety; music; autonomic nervous system; subjective cognition decline
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 201902035RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No