The Effects of Sensory Stimulative Activities on Sleep Performance in Elderly Adults: A Single-case Design
Primary Purpose
Sleep Disturbance
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention )
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disturbance
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.
Sites / Locations
- National Taiwan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioral: The sensory stimulative activity interventions
Arm Description
Outcomes
Primary Outcome Measures
ActiGraph GT9X
The objective sleep quality (sleep quality, sleep total time, sleep latency, awakening time during sleep)
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.
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.
Secondary Outcome Measures
The Center for Epidemiologic Studies Depression Scale
The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales.Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Geriatric Anxiety Scale - Chinese Version
The Geriatric Anxiety Scale is a 30-item self-report measure used to assess anxiety symptoms among older adults.Individuals are asked to indicate how often they have experienced each symptom during the last week, answering on a 4-point Likert scale ranging from "Not at all" (0) to "All the time" (3).
WHO Quality of Life-BREF (WHOQOL-BREF)
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Full Information
NCT ID
NCT04170049
First Posted
November 18, 2019
Last Updated
November 24, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04170049
Brief Title
The Effects of Sensory Stimulative Activities on Sleep Performance in Elderly Adults: A Single-case Design
Official Title
The Effects of Sensory Stimulative Activities on Sleep Performance in Community-dwelling Older Adults : A Single-case Design
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 6, 2020 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral: The sensory stimulative activity interventions
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention )
Intervention Description
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.
Primary Outcome Measure Information:
Title
ActiGraph GT9X
Description
The objective sleep quality (sleep quality, sleep total time, sleep latency, awakening time during sleep)
Time Frame
erveryday during 9 weeks
Title
The Pittsburgh Sleep Quality Index
Description
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.
Time Frame
once a week during 9 weeks
Title
The Insomnia Severity Index
Description
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.
Time Frame
once a week during 9 weeks
Secondary Outcome Measure Information:
Title
The Center for Epidemiologic Studies Depression Scale
Description
The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. The items of the scale are symptoms associated with depression which have been used in previously validated longer scales.Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Time Frame
once a week during 9 weeks
Title
Geriatric Anxiety Scale - Chinese Version
Description
The Geriatric Anxiety Scale is a 30-item self-report measure used to assess anxiety symptoms among older adults.Individuals are asked to indicate how often they have experienced each symptom during the last week, answering on a 4-point Likert scale ranging from "Not at all" (0) to "All the time" (3).
Time Frame
once a week during 9 weeks
Title
WHO Quality of Life-BREF (WHOQOL-BREF)
Description
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.
Time Frame
once a week during 9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Fen Mao
Phone
886-2-33668178
Email
huifen02@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Ning Yuan
Email
aysputink@hotmail.com
Facility Information:
Facility Name
National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Fen Mao
Phone
886-2-33668178
Email
huifen02@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of Sensory Stimulative Activities on Sleep Performance in Elderly Adults: A Single-case Design
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