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Clinical Trials/NCT04170049
NCT04170049
Unknown
Not Applicable

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

National Taiwan University Hospital1 site in 1 country6 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disturbance
Sponsor
National Taiwan University Hospital
Enrollment
6
Locations
1
Primary Endpoint
The Insomnia Severity Index
Last Updated
6 years ago

Overview

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.

Detailed Description

In this single-case designs study, we will recruit six volunteering elderly with primary insomnia and use A-B-A-C-A-D design for 9 weeks including the three periods of baseline phases for 1 week(A), the music intervention phase for 2 weeks(B), the proprioceptive intervention phase for 2 weeks(C) and the combination phase for 2 weeks(D). The main outcome measures include the objective sleeping quality measured everyday by the actigraphy recording the sleeping performance and physiological data during sleep, and the subjective sleeping quality measured every week via the Pittsburgh Sleep Quality Index and the Insomnia Severity. The secondary outcome measures, including the Center for Epidemiologic Studies Depression Scale, Geriatric Anxiety Scale - Chinese Version and WHOQOL-BREF, will be assessed weekly. The above results will present in visually analyzing graphed data to compare the performance among different phases and to evaluate the impacts of different interventions. This study will aim to preliminary investigate the feasibility and effectiveness of the music intervention, the proprioception intervention and the combination of both approaches on improving the objective sleeping performance and the subjective sleeping quality of the elderly.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
April 1, 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

The Insomnia Severity Index

Time Frame: once a week during 9 weeks

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.

ActiGraph GT9X

Time Frame: erveryday during 9 weeks

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

The Pittsburgh Sleep Quality Index

Time Frame: once a week during 9 weeks

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.

Secondary Outcomes

  • 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 Sites (1)

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