Elderly Sleep Disturbance Through Home Care Solution

NCT ID: NCT05302492

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2023-05-31

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.

Conditions

Aging; Sleep Disturbance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep apnea group with CPAP

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.

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

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

sleep disturbance without sleep apnea nor PLMS

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

Group Type: EXPERIMENTAL

Light box

Intervention Type: DEVICE

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

Interventions

CPAP

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

Intervention Type: DEVICE

Light box

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ning-hong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

202100552A3

Identifier Type: -

Identifier Source: org_study_id