- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04170049
The Effects of Sensory Stimulative Activities on Sleep Performance in Elderly Adults: A Single-case Design
The Effects of Sensory Stimulative Activities on Sleep Performance in Community-dwelling Older Adults : A Single-case Design
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hui-Fen Mao
- Phone Number: 886-2-33668178
- Email: huifen02@gmail.com
Study Contact Backup
- Name: Chih-Ning Yuan
- Email: aysputink@hotmail.com
Study Locations
-
-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University
-
Contact:
- Hui-Fen Mao
- Phone Number: 886-2-33668178
- Email: huifen02@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral: The sensory stimulative activity interventions
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ActiGraph GT9X
Time Frame: erveryday during 9 weeks
|
The objective sleep quality (sleep quality, sleep total time, sleep latency, awakening time during sleep)
|
erveryday during 9 weeks
|
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. |
once a week during 9 weeks
|
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.
|
once a week during 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Center for Epidemiologic Studies Depression Scale
Time Frame: once a week during 9 weeks
|
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.
|
once a week during 9 weeks
|
Geriatric Anxiety Scale - Chinese Version
Time Frame: once a week during 9 weeks
|
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).
|
once a week during 9 weeks
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Time Frame: once a week during 9 weeks
|
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.
|
once a week during 9 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201903021RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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