Skip to content

Elderly Sleep Disturbance Through Home Care Solution

Feasibility of Improvement for Elderly Sleep Disturbance Through Home Care Solution

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05302492
Enrollment
107
Registered
2022-03-31
Start date
2021-05-17
Completion date
2023-05-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Sleep Disturbance

Keywords

aging, sleep disturbance, CPAP, phototherapy, omics

Brief summary

Humans spend a third of their time on sleep. Therefore, maintaining a deep, stable and consistent sleep is very important for a good quality of life. Aging is often related to a decrease in the ability to fall asleep and maintain sleep. Getting older, various factors can worsen the normal sleep process, which is essential for restoring function and body function. Aging-related diseases, life changes, or own aging can disrupt the normal sleep cycle and seriously affect healthy aging. For example, the circadian rhythm and sleep consolidation will be broken with normal aging. These changes may lead to aging, or become part of the risk factors for diseases such as Alzheimer's disease. How to avoid disability and dementia by improving the quality of sleep to make the elderly healthy and aging, will bring huge effects to the economy, society, and health care. From this plan, investigators will participate in an integrated plan (main plan)- Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Healthy Aging. In the main plan, 500 subjects will be enrolled. All subjects consent to provide medical record and will be tested for sarcopenia, including body composition, 4-meter walk, handgrip strength. The subjects screened sleep-affected subjects. It is estimated that 250 people will be invited for home sleep testing, such as continuous positive pressure breathing aid (CPAP) for sleep apnea (OSA) (approximately 120 subjects). For non-OSA and non-periodic limb movement disorder (PLMS) sleep problems, take a phototherapy program (about 60 subjects). The following goals are expected to be achieved: 1. Link to the main project to explore the correlation between common sleep disorders in the elderly and blood pressure, cognition, sarcopenia, metabolomics or intestinal microbiome 2. To verify the prognosis of sleep apnea and sleep disorders after intervention.

Interventions

DEVICECPAP

CPAP: continue positive airway pressure ventilator is the standard treatment of OSA.

DEVICELight box

Light box: is the treatment choice for circadian rhythm disorders. now apply to sleep disturbance without OSA or PLMS.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Those who are willing to sign the written subject consent * Participants who participated in the integrated project (main project) - Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Healthy Aging * The results of the sleep questionnaire meet one of the following: 1. Pittsburgh Sleep Quality Scale (PSQI) \> 5 points 2. The Self-Sleep Assessment Questionnaire (STOP-BANG) is at high risk for sleep apnea (OSA)

Exclusion criteria

* Patients with severe cataracts who have not received treatment, patients with color blindness and chronic skin diseases (including psoriasis, eczema), or those who are considered by the host to be unable to receive light therapy. * Those who are unsuitable after evaluation by a physician.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline PSQI ( Pittsburg Sleep Quality Index ) at 3 months3 monthsSubjective sleep quality will be assessed by the PSQI questionnaire. The measure consists of 19 individual items, creating 7 components that produce one global score. Each component is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Secondary

MeasureTime frameDescription
Change from baseline total sleep time at 3 months3 monthsThe total sleep time, defined as the minutes of sleep between sleep onset and wake time, was calculated as a daily average from one week of actigraphy recordings. Increased total sleep time will be identified as improved objective sleep quality.
Change from baseline sleep onset latency at 3 months3 monthsThe sleep onset latency, defined as the minutes between lights off and first sleep episode, was calculated as a daily average from one week of actigraphy recordings. Decreased sleep onset latency will be identified as improved objective sleep quality.
Change from baseline wake after sleep onset (WASO) at 3 months3 monthsThe WASO, defined as the minutes awake during the sleep period after sleep onset, was calculated as a daily average from one week of actigraphy recordings. Decreased WASO (wake after sleep onset) will be identified as improved objective sleep quality.
Change from baseline sleep efficiency at 3 months3 monthsThe sleep efficiency, defined as the percent of time scored as sleep during the sleep period, was calculated as a daily average from one week of actigraphy recordings. Increased sleep efficiency will be identified as improved objective sleep quality.
Change from baseline handgrip strength at 3 months3 monthsThe handgrip strength (kg) was evaluated by Hand Dynamometer. (Jamar® Plus+ Digital Hand Dynamometer)
Change from baseline gait speed at 3 months3 monthsThe gait speed test was performed by recording the average time of walking 4 meters and representing with the distance (m) per second.
Change from baseline appendicular skeletal muscle mass at 3 months3 monthsThe appendicular skeletal muscle mass was evaluated by body composition analysis.(Tanita MC-780 MA)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026