Elderly Sleep Disturbance Through Home Care Solution

NCT05302492 | Completed

• 1 other identifier: 202100552A3
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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. 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. 2.To verify the prognosis of sleep apnea and sleep disorders after intervention.

Conditions

Aging; Sleep Disturbance

Keywords

aging; sleep disturbance; CPAP; phototherapy; omics

Outcome Measures

Primary Outcomes (1)

• Change from baseline PSQI ( Pittsburg Sleep Quality Index ) at 3 months

  Subjective 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.

  3 months

Secondary Outcomes (7)

• Change from baseline sleep efficiency at 3 months

  3 months

• Change from baseline total sleep time at 3 months

  3 months

• Change from baseline sleep onset latency at 3 months

  3 months

• Change from baseline wake after sleep onset (WASO) at 3 months

  3 months

• Change from baseline appendicular skeletal muscle mass at 3 months

  3 months

Study Arms (2)

Sleep apnea group with CPAP

EXPERIMENTAL

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.

Device: CPAP

sleep disturbance without sleep apnea nor PLMS

EXPERIMENTAL

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

Device: Light box

Interventions

CPAP DEVICE

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

Sleep apnea group with CPAP

Light box DEVICE

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

sleep disturbance without sleep apnea nor PLMS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• Pittsburgh Sleep Quality Scale (PSQI) \> 5 points
• The Self-Sleep Assessment Questionnaire (STOP-BANG) is at high risk for sleep apnea (OSA)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ning-hong Chen, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 31, 2022
• Study Start: May 17, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: February 7, 2024

Record last verified: 2023-05

Locations

TW (1)