Clinical trial NCT04170049: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disturbance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 6
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. psychiatric or neurological problems
2. a history of alcohol / drug abuse
3. Hearing impaired.

Primary outcomes:
measure: ActiGraph GT9X
timeFrame: erveryday during 9 weeks
measure: The Pittsburgh Sleep Quality Index
timeFrame: once a week during 9 weeks
measure: The Insomnia Severity Index
timeFrame: once a week during 9 weeks
Secondary outcomes:
measure: The Center for Epidemiologic Studies Depression Scale
timeFrame: once a week during 9 weeks
measure: Geriatric Anxiety Scale - Chinese Version
timeFrame: once a week during 9 weeks
measure: WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: once a week during 9 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
References: