Sleep DisturbanceNCT04170049
The Effects of Sensory Stimulative Activities on Sleep Performance in Elderly Adults: A Single-case Design
A study testing Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention ) in people with Sleep Disturbance, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention )
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- have experienced insomnia (PSQI>5 at screening;) for at least one month.
- Over 65 years of age or older.
Who cannot join
- psychiatric or neurological problems
- a history of alcohol / drug abuse
- Hearing impaired.
Trial locations and contacts
1 site in 1 country.
Chih-Ning Yuan contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei, 100
Hui-Fen Mao, 886-2-33668178, huifen02@gmail.com
About this study
Official title: The Effects of Sensory Stimulative Activities on Sleep Performance in Community-dwelling Older Adults : A Single-case Design
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.
Read the 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.
- Conditions
- Sleep Disturbance
- Being tested
- Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention )
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention )Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: The sensory stimulative activity interventions | Experimental | Not described Receives: Behavioral: Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ActiGraph GT9X
The objective sleep quality (sleep quality, sleep total time, sleep latency, awakening time during sleep)
Measured: 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.
Measured: 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.
Measured: once a week during 9 weeks
Secondary outcomes (3)
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.
Measured: once a week during 9 weeks
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).
Measured: once a week during 9 weeks
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.
Measured: once a week during 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Apr 2019
- Primary completion6 May 2020 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170049
- Sponsor's protocol ID
- 201903021RINA
- Status last verified
- Apr 2019
- First submitted
- 18 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sensory Stimulative Activities on Sleep Performance in Community-dwelling Older Adults : A Single-case Design
- ClinicalTrials.gov ID
- NCT04170049
- Acronym / sponsor ID
- 201903021RINA
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 6 May 2020 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral: The sensory stimulative activity interventions | Experimental | Behavioral: Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention ) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- have experienced insomnia (PSQI>5 at screening;) for at least one month.
- Over 65 years of age or older.
Key exclusion criteria (3 listed)
- psychiatric or neurological problems
- a history of alcohol / drug abuse
- Hearing impaired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention )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. | Behavioural | Behavioral: The sensory stimulative activity interventions |
Primary outcome
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.
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.
3 secondary outcomes
The Center for Epidemiologic Studies Depression Scale
Time frame: once a week during 9 weeks
Geriatric Anxiety Scale - Chinese Version
Time frame: once a week during 9 weeks
WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: once a week during 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Ning Yuan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention ) in people with Sleep Disturbance, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Fen Mao (886-2-33668178, huifen02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ActiGraph GT9X (time frame: erveryday during 9 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.