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NCT Number: NCT05302492

Elderly Sleep Disturbance Through Home Care Solution

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.

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Key information

Conditions

Aging Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Pittsburgh Sleep Quality Scale (PSQI) > 5 points
  • 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.

Treatment and study plan

CPAP

Device

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

Light box

Device

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Change from baseline sleep efficiency at 3 months

    Time frame: 3 months

    The 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.

  2. Change from baseline total sleep time at 3 months

    Time frame: 3 months

    The 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.

  3. Change from baseline sleep onset latency at 3 months

    Time frame: 3 months

    The 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.

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

    Time frame: 3 months

    The 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.

  5. Change from baseline appendicular skeletal muscle mass at 3 months

    Time frame: 3 months

    The appendicular skeletal muscle mass was evaluated by body composition analysis.(Tanita MC-780 MA)

  6. Change from baseline handgrip strength at 3 months

    Time frame: 3 months

    The handgrip strength (kg) was evaluated by Hand Dynamometer. (Jamar® Plus+ Digital Hand Dynamometer)

  7. Change from baseline gait speed at 3 months

    Time frame: 3 months

    The gait speed test was performed by recording the average time of walking 4 meters and representing with the distance (m) per second.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Feasibility of Improvement for Elderly Sleep Disturbance Through Home Care Solution

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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