Clinical trial NCT04177160: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: music
anxiety
autonomic nervous system
subjective cognition decline
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Heart rate variability
timeFrame: 45 minutes
measure: Skin conductance
timeFrame: 45 minutes
measure: Visual Analogue Scale of Anxiety
timeFrame: After each stimulus task and intervention: on the 10th, 15th, 20th, 25th, 35th and 40th minute.
Secondary outcomes:
measure: Chinese version of state-trait anxiety inventory-trait version
timeFrame: Baseline
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
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.