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AgingNCT05302492

Elderly Sleep Disturbance Through Home Care Solution

A study testing CPAP and Light box in people with Aging and Sleep Disturbance, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aging, Sleep Disturbance
What is being tested?
CPAP and Light box
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteTaiwan
Study dates
17 May 2021to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: Feasibility of Improvement for 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.
Being tested
CPAP, Light box
Keywords
aging, sleep disturbance, CPAP, phototherapy, omics
Medical subject headings
Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAPDevice

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

  • Light boxDevice

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

Study groups in NCT05302492
Study groupRoleWhat they receive
Sleep apnea group with CPAPExperimentalIntervention 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.
Receives: Device: CPAP
sleep disturbance without sleep apnea nor PLMSExperimentalIntervention 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
Receives: Device: Light box

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (7)

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 3 months

  4. 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.

    Measured: 3 months

  5. 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)

    Measured: 3 months

  6. Change from baseline handgrip strength at 3 months

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

    Measured: 3 months

  7. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start17 May 2021
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302492
Sponsor's protocol ID
202100552A3
Status last verified
May 2023
First submitted
11 Feb 2022
Last updated
7 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CPAP and Light box in people with Aging and Sleep Disturbance, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline PSQI ( Pittsburg Sleep Quality Index ) at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05302492.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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