Elderly Sleep Disturbance Through Home Care Solution

Chang Gung Medical Foundation

Status: Completed

Conditions: Aging; Sleep Disturbance

Treatments: Device: Light box; Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT05302492

202100552A3

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Sleep apnea group with CPAP

Experimental group

Description:

Intervention group: CPAP for 3 months in elderly diagnosis with sleep apnea and AHI \> 15/h. Control group: sleep apnea and patient refuse treatment or poor compliance.

Treatment:

Device: CPAP

sleep disturbance without sleep apnea nor PLMS

Experimental group

Description:

Intervention group: light box on elderly with sleep disturbance with PSQI \> 5 and no OSA and no PLMS control group: elderly with sleep disturbance with PSQI \> 5 and no OSA and no PLMS refuse light box or poor compliance

Treatment:

Device: Light box