Clinical trial NCT05302492: Elderly Sleep Disturbance Through Home Care Solution
Official title: Feasibility of Improvement for Elderly Sleep Disturbance Through Home Care Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Sleep Disturbance
Keywords: aging
sleep disturbance
CPAP
phototherapy
omics
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 107
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline PSQI ( Pittsburg Sleep Quality Index ) at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline sleep efficiency at 3 months
timeFrame: 3 months
measure: Change from baseline total sleep time at 3 months
timeFrame: 3 months
measure: Change from baseline sleep onset latency at 3 months
timeFrame: 3 months
measure: Change from baseline wake after sleep onset (WASO) at 3 months
timeFrame: 3 months
measure: Change from baseline appendicular skeletal muscle mass at 3 months
timeFrame: 3 months
measure: Change from baseline handgrip strength at 3 months
timeFrame: 3 months
measure: Change from baseline gait speed at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ning-hong Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: