The Effects of Sensory Stimulative Activities on Sleep Performance in Elderly Adults: A Single-case Design

NCT04170049 | Unknown

• 1 other identifier: 201903021RINA
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Older adults have a high prevalence of sleep disturbances, which negatively and severely impact their health and quality of life. Research indicated that 43% elderly outpatients in Taiwan have used benzodiazepine, which collectively led to great medical expenditure. Non-pharmacological treatments are highly recommended as first priority for sleep disturbance in practice. Music interventions have been reported to modulate the sympathetic nervous system and to improve the elderly's sleeping performance. Proprioceptive interventions can also activate the parasympathetic nervous system, providing calming effects and significantly reducing anxiety, hyperactivity and agitation in various populations. However, the effects of these intervention on the sleep disturbances in the elderly remain unclear. The research purpose is to investigate the effects of two sensory activities that are easily executed in everyday life - auditory (e.g. listening to the music before sleeping) and proprioceptive (e.g. joint compression exercises) interventions on improving the sleep performance of the elderly. Subjective sleeping quality assessment (Pittsburgh Sleep Quality Index \& Insomnia Severity Index) and objective physiological records measured by actigraphy are used as outcome measures.

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (3)

• ActiGraph GT9X

  The objective sleep quality (sleep quality, sleep total time, sleep latency, awakening time during sleep)

  erveryday during 9 weeks

• The Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper.

  once a week during 9 weeks

• The Insomnia Severity Index

  a brief instrument(7 items) that was designed to assess the severity of both nighttime and daytime components of insomnia.(Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe)) It is available in several languages and is increasingly used as a metric of treatment response in clinical research.

  once a week during 9 weeks

Secondary Outcomes (3)

• The Center for Epidemiologic Studies Depression Scale

  once a week during 9 weeks

• Geriatric Anxiety Scale - Chinese Version

  once a week during 9 weeks

• WHO Quality of Life-BREF (WHOQOL-BREF)

  once a week during 9 weeks

Study Arms (1)

Behavioral: The sensory stimulative activity interventions

EXPERIMENTAL

Behavioral: Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention )

Interventions

Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention ) BEHAVIORAL

Music intervention: Listening to soft music was found to be an effective method of relaxation, as indicated by a shift of the autonomic balance toward parasympathetic activity. Participants listen to preferred soft music for 30 minutes before sleeping. Proprioceptive intervention: The proprioceptive intervention can activate the parasympathetic nervous system through pathways of the central nervous system, providing calming effects that significantly reduce anxiety, hyperactivity and agitation in various populations.Participants do 10-minute joint compression exercise three times per day by themselves.

Behavioral: The sensory stimulative activity interventions

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• have experienced insomnia (PSQI\>5 at screening;) for at least one month.
• Over 65 years of age or older.

You may not qualify if:

• psychiatric or neurological problems
• a history of alcohol / drug abuse
• Hearing impaired.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Hui-Fen Mao

CONTACT

886-2-33668178; huifen02@gmail.com

Chih-Ning Yuan

CONTACT

aysputink@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: April 1, 2019
• Primary Completion: May 6, 2020
• Study Completion: April 1, 2022
• Last Updated: November 26, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)