NCT04177160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

7 months

First QC Date

November 13, 2019

Last Update Submit

January 17, 2021

Conditions

Dementia

Keywords

musicanxietyautonomic nervous systemsubjective cognition decline

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Chinese version of state-trait anxiety inventory-trait version

    Baseline

Study Arms (2)

SCD subjects

EXPERIMENTAL

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

Behavioral: MusicBehavioral: White noise

Healthy controls

EXPERIMENTAL

Voluntary healthy elderly recruited from the community.

Behavioral: MusicBehavioral: White noise

Interventions

MusicBEHAVIORAL

Subjects sit still and listen to preferred music for 5 minutes.

Healthy controlsSCD subjects
White noiseBEHAVIORAL

Subjects sit still and listen to white noise for 5 minutes.

Healthy controlsSCD subjects

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 24798886BACKGROUND

MeSH Terms

Conditions

DementiaAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 26, 2019

Study Start

April 15, 2019

Primary Completion

November 13, 2019

Study Completion

December 31, 2019

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)