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Elderly Sleep Disturbance Through Home Care Solution

Primary Purpose

Aging, Sleep Disturbance

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
CPAP
Light box
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring aging, sleep disturbance, CPAP, phototherapy, omics

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleep apnea group with CPAP

sleep disturbance without sleep apnea nor PLMS

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline sleep efficiency at 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.
Change from baseline total sleep time at 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.
Change from baseline sleep onset latency at 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.
Change from baseline wake after sleep onset (WASO) at 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.
Change from baseline appendicular skeletal muscle mass at 3 months
The appendicular skeletal muscle mass was evaluated by body composition analysis.(Tanita MC-780 MA)
Change from baseline handgrip strength at 3 months
The handgrip strength (kg) was evaluated by Hand Dynamometer. (Jamar® Plus+ Digital Hand Dynamometer)
Change from baseline gait speed at 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.

Full Information

First Posted
February 11, 2022
Last Updated
July 21, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05302492
Brief Title
Elderly Sleep Disturbance Through Home Care Solution
Official Title
Feasibility of Improvement for Elderly Sleep Disturbance Through Home Care Solution
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 24, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Sleep Disturbance
Keywords
aging, sleep disturbance, CPAP, phototherapy, omics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep apnea group with CPAP
Arm Type
Experimental
Arm 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.
Arm Title
sleep disturbance without sleep apnea nor PLMS
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
CPAP: continue positive airway pressure ventilator is the standard treatment of OSA.
Intervention Type
Device
Intervention Name(s)
Light box
Intervention Description
Light box: is the treatment choice for circadian rhythm disorders. now apply to sleep disturbance without OSA or PLMS.
Primary Outcome Measure Information:
Title
Change from baseline PSQI ( Pittsburg Sleep Quality Index ) at 3 months
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from baseline sleep efficiency at 3 months
Description
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.
Time Frame
3 months
Title
Change from baseline total sleep time at 3 months
Description
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.
Time Frame
3 months
Title
Change from baseline sleep onset latency at 3 months
Description
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.
Time Frame
3 months
Title
Change from baseline wake after sleep onset (WASO) at 3 months
Description
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.
Time Frame
3 months
Title
Change from baseline appendicular skeletal muscle mass at 3 months
Description
The appendicular skeletal muscle mass was evaluated by body composition analysis.(Tanita MC-780 MA)
Time Frame
3 months
Title
Change from baseline handgrip strength at 3 months
Description
The handgrip strength (kg) was evaluated by Hand Dynamometer. (Jamar® Plus+ Digital Hand Dynamometer)
Time Frame
3 months
Title
Change from baseline gait speed at 3 months
Description
The gait speed test was performed by recording the average time of walking 4 meters and representing with the distance (m) per second.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning-hong Chen, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Elderly Sleep Disturbance Through Home Care Solution

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