DepressionNCT05852912
Effects on Physical and Mental Prognosis and Quality of Life of Elderly People With Depressive Symptoms
An observational study of Depression, run by Chang Gung Memorial Hospital.
Trial summary
Mild mental illnesses such as depression, anxiety, and sleep disorders in the elderly are also major health issues for Taiwanese. Mild mental illnesses that cannot be effectively treated may worsen existing chronic diseases. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Jun 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Older adult
Study population: The elderly who's age is more than or equal to 65 years old.
Who may be able to join
- Age is more than or equal to 65 years old
- Able to provide informed consent to participate in the research.
- Can understand the instructions, and coduct the questionnaire assessment and physical function measurement.
Who cannot join
- Those unable to give consent to participate in the research.
- Those who cannot understand the instructions, difficult to coduct questionnaire assessment and physical function measurement.
- Severe disease state (respiratory distress requiring intubation or patient with terminal illness) or severe brain injury or severe Dementia.
- Snstable patients and patients with substance abuse.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects on Physical and Mental Prognosis and Quality of Life of Elderly People With Depressive Symptoms: Development of Wearable Devices and Telemedicine as Assessment Tools
Mild mental illnesses such as depression, anxiety, and sleep disorders in the elderly are also major health issues for Taiwanese. Mild mental illnesses that cannot be effectively treated may worsen existing chronic diseases. However, there is a lack of objective, convenient and effective assessment tools for the cognitive, emotional, sleep and other mental health of the elderly. The development of these assessment tools can be used to quantify the degree of abnormality, provide early diagnosis, and evaluate the effectiveness of long-term care.
In recent years, the progress of physiological sensing technology and wearable devices,telemedicine devices and various computer information integration software has provided objective clinical data. This study will use "wearable devices", "telemedicine" and "computer information software" to evaluate whether elderly with mild mental illness have a poor prognosis. In this way, an intelligent care model for "cognitive, emotional, sleep and other mental health" for elderly is developed.
Read the detailed description
Mild mental illnesses such as depression, anxiety, and sleep disorders in the elderly are also major health issues for Taiwanese. Mild mental illnesses that cannot be effectively treated may worsen existing chronic diseases. However, there is a lack of objective, convenient and effective assessment tools for the cognitive, emotional, sleep and other mental health of the elderly. The development of these assessment tools can be used to quantify the degree of abnormality, provide early diagnosis, and evaluate the effectiveness of long-term care.
In recent years, the progress of physiological sensing technology and wearable devices,telemedicine devices and various computer information integration software has provided objective clinical data. This study will use "wearable devices", "telemedicine" and "computer information software" to evaluate whether elderly with mild mental illness have a poor prognosis. In this way, an intelligent care model for "cognitive, emotional, sleep and other mental health" for elderly is developed.
This study is expected to have the following objectives:
- To understand the prevalence and current situation of Taiwanese elderly complicated with mild mental illnesses (such as anxiety, insomnia, etc.).
- Establish a physical and mental assessment tool for the elderly, integrating different scales such as physical health, mental health, and mobility into a complete and convenient information interface for the elderly, caregivers, and medical staff to use to facilitate cross-field connections Communities and hospitals, providing continuum of care.
- Introduce wearable devices and computerized software to analyze the prognosis of elderly hypertensive patients.
Through this project, it is expected to combine the two majors of medical treatment and information technology, and integrate various assessment tools into a convenient information interface, making it easy for the elderly and caregivers to use, and even linking to the medical network to assist in rapid diagnosis, referral and receive treatment. The collected data can be used for big data analysis in the future to provide further national policy reference.
- Conditions
- Depression
- Keywords
- Elderly, wearable devices
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| elders combined with mild mental illness | elders combined with mild mental illness(120 subjects) | |
| elders combined without mild mental illness | elders combined without mild mental illness(120 subjects) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy
Change in sleep latency (mins) based on actigraphy during the study.
Measured: Four times a year until the study is completed (up to 3 years)
Secondary outcomes (17)
Actigraphy-SOL
sleep onset latency (SOL)based on actigraphy during the study.
Measured: Four times a year until the study is completed (up to 3 years)
Actigraphy-TST
Total sleep time (TST, mins) based on actigraphy during the study.
Measured: Four times a year until the study is completed (up to 3 years)
Actigraphy-SE
Sleep efficiency (SE, %) based on actigraphy during the study.
Measured: Four times a year until the study is completed (up to 3 years)
Actigraphy-WASO
Wake after sleep onset (WASO) based on actigraphy during the study.
Measured: Four times a year until the study is completed (up to 3 years)
Actigraphy-Awake time
Awake time based on actigraphy during the study.
Measured: Four times a year until the study is completed (up to 3 years)
Actigraphy-TIB
Time in bed(TIB) based on actigraphy during the study.
Measured: Four times a year until the study is completed (up to 3 years)
Conners' Continuous Performance Test (CPT)
The Conners Continuous Performance Test is a computer administered test that is designed to assess problems with attention,impulsivity and vigilance .Many statistics are computed including omission errors , commission errors, hit reaction time, hit reaction time standard error, detectability, response style, perseverations , hit reaction time by block, standard error by block, reaction time by ISI , and standard error by ISI. These statistics are converted to T-scores and can be interpreted in terms of various aspects of attention including inattention, impulsivity, and vigilance.Higher rates of correct detections indicate better attentional capacity.
Measured: Four times a year until the study is completed (up to 3 years)
Epworth Sleepoiness Scale (ESS)
Epworth Sleepoiness Scale (ESS) assesses the responder's propensity to doze or fall asleep during 8 common daily activities, such as: sitting and reading; sitting inactive in a public place; sitting and talking to someone; sitting quietly after a lunch without alcohol; or in a car, while stopped for a few minutes in traffic.
Score of 0 to 10 indicate normal range of sleepiness in healthy adults.;11 to 14 indicate mild sleepiness;15 to 17 indicate moderate sleepiness;18 to 24 indicate severe sleepiness .
Measured: Four times a year until the study is completed (up to 3 years)
Short Form-36 (SF-36)
36-Item Short-Form Health Survey (SF-36) includes 11 major questions that evaluate eight components (0-100), with higher scores indicating better outcome.These components include physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional wellbeing, social functioning, pain, and general health.
Measured: Four times a year until the study is completed (up to 3 years)
Geriatric Depression Scale-15(GDS-15)
The Geriatric Depression Scale-15 is a screening tool used to identify symptoms of depression in elderly adults.Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.It takes about 5 to 7 minutes to complete.
Measured: Four times a year until the study is completed (up to 3 years)
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a test used by healthcare providers to evaluate people with memory loss or other symptoms of cognitive decline. It can help identify those at risk for developing Alzheimer's disease and other forms of dementia. It is also used as a screening tool for conditions like Parkinson's disease, brain tumors, substance abuse, and head trauma.
The MoCA checks different types of cognitive or thinking abilities. These include:orientation,short-term memory/delayed recall,executive function/visuospatial ability,language,abstraction,naming,attention.
Scores on the MoCA range from zero to 30. A score of 26 and higher is considered normal.1 point is added to the test-taker's score if they have 12 years or less of formal education.
The MoCA contains 30 questions and takes around 10 to 12 minutes to complete.
Measured: Four times a year until the study is completed (up to 3 years)
Hospital Anxiety and Depression Scale(HADS)
The Hospital Anxiety and Depression Scale aims to measure symptoms of anxiety and depression.As in the HADS, the response to each item is rated 0-3. Higher scores indicate higher levels of anxiety or depression.
Measured: Four times a year until the study is completed (up to 3 years)
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire for assessing the subjective sleep quality, which consists of 19 items and can be calculated and combined into 7 clinically-derived component score (0-3), with higher scores indicating worse sleep quality.
Measured: Four times a year until the study is completed (up to 3 years)
Activities of Daily Living (ADL)
The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.Scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-100 indicates "slight" dependency.
Measured: Four times a year until the study is completed (up to 3 years)
Lawton Instrumental Activities of Daily Living Scale (IADL)
The Instrumental Activities of Daily Living (IADL) Scale is used to assess independent living skills of an individual and measures functional ability as well as declines and improvements over time. The test measures eight realms of function through self report, which attempt to assess everyday functional competence in the elderly. This is done by evaluating a more complex set of behaviours like telephoning, shopping, food preparation, housekeeping, laundering, use of transportation, use of medicine, and financial behaviour. Each domain measured by the scale relies on either cognitive or physical function, though all require some degree of both.
The Lawton IADL scale can be scored in several ways, the most common method is to rate each item either dichotomously (0 = less able, 1 = more able) or trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and sum the eight responses. The higher the score, the greater the person's abilities.
Measured: Four times a year until the study is completed (up to 3 years)
Insomnia Severity Index(ISI)
The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia.The usual recall period is the "last month" and the dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Measured: Four times a year until the study is completed (up to 3 years)
Clinical Frailty Scale (CFS)
The clinical frailty scale is a 9-point scale that quantifies frailty based on function in individual patients. It is complemented by a visual chart to assist with the classification of frailty. Higher scores indicate increased frailty and associated risks.
Measured: Four times a year until the study is completed (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Shu Huang, Study director, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852912
- Sponsor's protocol ID
- 202200501B0C603
- Status last verified
- Apr 2023
- First submitted
- 2 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blood ML, Sack RL, Percy DC, Pen JC. A comparison of sleep detection by wrist actigraphy, behavioral response, and polysomnography. Sleep. 1997 Jun;20(6):388-95.
PubMed 9302721Chen NH, Johns MW, Li HY, Chu CC, Liang SC, Shu YH, Chuang ML, Wang PC. Validation of a Chinese version of the Epworth sleepiness scale. Qual Life Res. 2002 Dec;11(8):817-21. doi: 10.1023/a:1020818417949.
PubMed 12482165Chu KC, Huang YS, Tseng CF, Huang HJ, Wang CH, Tai HY. Reliability and validity of DS-ADHD: A decision support system on attention deficit hyperactivity disorders. Comput Methods Programs Biomed. 2017 Mar;140:241-248. doi: 10.1016/j.cmpb.2016.12.003. Epub 2016 Dec 16.
PubMed 28254080Edd EM, Flores S. Sleepiness or excessive daytime somnolence. Geriatr Nurs. 2009 Jan-Feb;30(1):53-60. doi: 10.1016/j.gerinurse.2008.11.004.
PubMed 19215814Hegerl U, Wilk K, Olbrich S, Schoenknecht P, Sander C. Hyperstable regulation of vigilance in patients with major depressive disorder. World J Biol Psychiatry. 2012 Sep;13(6):436-46. doi: 10.3109/15622975.2011.579164. Epub 2011 Jul 4.
PubMed 21722018Huang YL, Liu RY, Wang QS, Van Someren EJ, Xu H, Zhou JN. Age-associated difference in circadian sleep-wake and rest-activity rhythms. Physiol Behav. 2002 Aug;76(4-5):597-603. doi: 10.1016/s0031-9384(02)00733-3.
PubMed 12126998Hung CI, Weng LJ, Su YJ, Liu CY. Depression and somatic symptoms scale: a new scale with both depression and somatic symptoms emphasized. Psychiatry Clin Neurosci. 2006 Dec;60(6):700-8. doi: 10.1111/j.1440-1819.2006.01585.x.
PubMed 17109704Ismail Z, Gatchel J, Bateman DR, Barcelos-Ferreira R, Cantillon M, Jaeger J, Donovan NJ, Mortby ME. Affective and emotional dysregulation as pre-dementia risk markers: exploring the mild behavioral impairment symptoms of depression, anxiety, irritability, and euphoria - CORRIGENDUM. Int Psychogeriatr. 2019 Jan;31(1):157. doi: 10.1017/S1041610218000637. Epub 2018 Nov 21. No abstract available.
PubMed 30461372Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888Kemp AH, Quintana DS, Felmingham KL, Matthews S, Jelinek HF. Depression, comorbid anxiety disorders, and heart rate variability in physically healthy, unmedicated patients: implications for cardiovascular risk. PLoS One. 2012;7(2):e30777. doi: 10.1371/journal.pone.0030777. Epub 2012 Feb 15.
PubMed 22355326Kok RM, Reynolds CF 3rd. Management of Depression in Older Adults: A Review. JAMA. 2017 May 23;317(20):2114-2122. doi: 10.1001/jama.2017.5706.
PubMed 28535241Kim J, Nakamura T, Kikuchi H, Sasaki T, Yamamoto Y. Co-variation of depressive mood and locomotor dynamics evaluated by ecological momentary assessment in healthy humans. PLoS One. 2013 Sep 13;8(9):e74979. doi: 10.1371/journal.pone.0074979. eCollection 2013.
PubMed 24058642Lin C, Chin WC, Huang YS, Chu KC, Paiva T, Chen CC, Guilleminault C. Different circadian rest-active rhythms in Kleine-Levin syndrome: a prospective and case-control study. Sleep. 2021 Sep 13;44(9):zsab096. doi: 10.1093/sleep/zsab096.
PubMed 33851710Musiek ES, Bhimasani M, Zangrilli MA, Morris JC, Holtzman DM, Ju YS. Circadian Rest-Activity Pattern Changes in Aging and Preclinical Alzheimer Disease. JAMA Neurol. 2018 May 1;75(5):582-590. doi: 10.1001/jamaneurol.2017.4719.
PubMed 29379963Olbrich S, Sander C, Minkwitz J, Chittka T, Mergl R, Hegerl U, Himmerich H. EEG vigilance regulation patterns and their discriminative power to separate patients with major depression from healthy controls. Neuropsychobiology. 2012 Jun;65(4):188-94. doi: 10.1159/000337000. Epub 2012 Apr 26.
PubMed 22538271
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Physical and Mental Prognosis and Quality of Life of Elderly People With Depressive Symptoms: Development of Wearable Devices and Telemedicine as Assessment Tools
- ClinicalTrials.gov ID
- NCT05852912
- Acronym / sponsor ID
- 202200501B0C603
- Conditions
- Depression
- Keywords
- Elderly, wearable devices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild mental illnesses such as depression, anxiety, and sleep disorders in the elderly are also major health issues for Taiwanese. Mild mental illnesses that cannot be effectively treated may worsen existing chronic diseases. However, there is a lack of objective, convenient and effective assessment tools for the cognitive, emotional, sleep and other mental health of the elderly. The development of these assessment tools can be used to quantify the degree of abnormality, provide early diagnosis, and evaluate the effectiveness of long-term care.
In recent years, the progress of physiological sensing technology and wearable devices,telemedicine devices and various computer information integration software has provided objective clinical data. This study will use "wearable devices", "telemedicine" and "computer information software" to evaluate whether elderly with mild mental illness have a poor prognosis. In this way, an intelligent care model for "cognitive, emotional, sleep and other mental health" for elderly is developed.
Detailed description
Mild mental illnesses such as depression, anxiety, and sleep disorders in the elderly are also major health issues for Taiwanese. Mild mental illnesses that cannot be effectively treated may worsen existing chronic diseases. However, there is a lack of objective, convenient and effective assessment tools for the cognitive, emotional, sleep and other mental health of the elderly. The development of these assessment tools can be used to quantify the degree of abnormality, provide early diagnosis, and evaluate the effectiveness of long-term care.
In recent years, the progress of physiological sensing technology and wearable devices,telemedicine devices and various computer information integration software has provided objective clinical data. This study will use "wearable devices", "telemedicine" and "computer information software" to evaluate whether elderly with mild mental illness have a poor prognosis. In this way, an intelligent care model for "cognitive, emotional, sleep and other mental health" for elderly is developed.
This study is expected to have the following objectives:
- To understand the prevalence and current situation of Taiwanese elderly complicated with mild mental illnesses (such as anxiety, insomnia, etc.).
- Establish a physical and mental assessment tool for the elderly, integrating different scales such as physical health, mental health, and mobility into a complete and convenient information interface for the elderly, caregivers, and medical staff to use to facilitate cross-field connections Communities and hospitals, providing continuum of care.
- Introduce wearable devices and computerized software to analyze the prognosis of elderly hypertensive patients.
Through this project, it is expected to combine the two majors of medical treatment and information technology, and integrate various assessment tools into a convenient information interface, making it easy for the elderly and caregivers to use, and even linking to the medical network to assist in rapid diagnosis, referral and receive treatment. The collected data can be used for big data analysis in the future to provide further national policy reference.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elders combined with mild mental illness | – | –elders combined with mild mental illness(120 subjects) |
| elders combined without mild mental illness | – | –elders combined without mild mental illness(120 subjects) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The elderly who's age is more than or equal to 65 years old.
Key inclusion criteria (3 listed)
- Age is more than or equal to 65 years old
- Able to provide informed consent to participate in the research.
- Can understand the instructions, and coduct the questionnaire assessment and physical function measurement.
Key exclusion criteria (4 listed)
- Those unable to give consent to participate in the research.
- Those who cannot understand the instructions, difficult to coduct questionnaire assessment and physical function measurement.
- Severe disease state (respiratory distress requiring intubation or patient with terminal illness) or severe brain injury or severe Dementia.
- Snstable patients and patients with substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Actigraphy
Time frame: Four times a year until the study is completed (up to 3 years)
Change in sleep latency (mins) based on actigraphy during the study.
17 secondary outcomes
Actigraphy-SOL
Time frame: Four times a year until the study is completed (up to 3 years)
Actigraphy-TST
Time frame: Four times a year until the study is completed (up to 3 years)
Actigraphy-SE
Time frame: Four times a year until the study is completed (up to 3 years)
Actigraphy-WASO
Time frame: Four times a year until the study is completed (up to 3 years)
Actigraphy-Awake time
Time frame: Four times a year until the study is completed (up to 3 years)
Actigraphy-TIB
Time frame: Four times a year until the study is completed (up to 3 years)
Conners' Continuous Performance Test (CPT)
Time frame: Four times a year until the study is completed (up to 3 years)
Epworth Sleepoiness Scale (ESS)
Time frame: Four times a year until the study is completed (up to 3 years)
Short Form-36 (SF-36)
Time frame: Four times a year until the study is completed (up to 3 years)
Geriatric Depression Scale-15(GDS-15)
Time frame: Four times a year until the study is completed (up to 3 years)
Montreal Cognitive Assessment (MoCA)
Time frame: Four times a year until the study is completed (up to 3 years)
Hospital Anxiety and Depression Scale(HADS)
Time frame: Four times a year until the study is completed (up to 3 years)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Four times a year until the study is completed (up to 3 years)
Activities of Daily Living (ADL)
Time frame: Four times a year until the study is completed (up to 3 years)
Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: Four times a year until the study is completed (up to 3 years)
Insomnia Severity Index(ISI)
Time frame: Four times a year until the study is completed (up to 3 years)
Clinical Frailty Scale (CFS)
Time frame: Four times a year until the study is completed (up to 3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Results publication: PubMed 9302721Blood ML, Sack RL, Percy DC, Pen JC. A comparison of sleep detection by wrist actigraphy, behavioral response, and polysomnography. Sleep. 1997 Jun;20(6):388-95.
- Results publication: PubMed 12482165Chen NH, Johns MW, Li HY, Chu CC, Liang SC, Shu YH, Chuang ML, Wang PC. Validation of a Chinese version of the Epworth sleepiness scale. Qual Life Res. 2002 Dec;11(8):817-21. doi: 10.1023/a:1020818417949.
- Results publication: PubMed 28254080Chu KC, Huang YS, Tseng CF, Huang HJ, Wang CH, Tai HY. Reliability and validity of DS-ADHD: A decision support system on attention deficit hyperactivity disorders. Comput Methods Programs Biomed. 2017 Mar;140:241-248. doi: 10.1016/j.cmpb.2016.12.003. Epub 2016 Dec 16.
- Results publication: PubMed 19215814Edd EM, Flores S. Sleepiness or excessive daytime somnolence. Geriatr Nurs. 2009 Jan-Feb;30(1):53-60. doi: 10.1016/j.gerinurse.2008.11.004.
- Results publication: PubMed 21722018Hegerl U, Wilk K, Olbrich S, Schoenknecht P, Sander C. Hyperstable regulation of vigilance in patients with major depressive disorder. World J Biol Psychiatry. 2012 Sep;13(6):436-46. doi: 10.3109/15622975.2011.579164. Epub 2011 Jul 4.
- Results publication: PubMed 12126998Huang YL, Liu RY, Wang QS, Van Someren EJ, Xu H, Zhou JN. Age-associated difference in circadian sleep-wake and rest-activity rhythms. Physiol Behav. 2002 Aug;76(4-5):597-603. doi: 10.1016/s0031-9384(02)00733-3.
- Results publication: PubMed 17109704Hung CI, Weng LJ, Su YJ, Liu CY. Depression and somatic symptoms scale: a new scale with both depression and somatic symptoms emphasized. Psychiatry Clin Neurosci. 2006 Dec;60(6):700-8. doi: 10.1111/j.1440-1819.2006.01585.x.
- Results publication: PubMed 30461372Ismail Z, Gatchel J, Bateman DR, Barcelos-Ferreira R, Cantillon M, Jaeger J, Donovan NJ, Mortby ME. Affective and emotional dysregulation as pre-dementia risk markers: exploring the mild behavioral impairment symptoms of depression, anxiety, irritability, and euphoria - CORRIGENDUM. Int Psychogeriatr. 2019 Jan;31(1):157. doi: 10.1017/S1041610218000637. Epub 2018 Nov 21. No abstract available.
- Results publication: PubMed 1798888Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Results publication: PubMed 22355326Kemp AH, Quintana DS, Felmingham KL, Matthews S, Jelinek HF. Depression, comorbid anxiety disorders, and heart rate variability in physically healthy, unmedicated patients: implications for cardiovascular risk. PLoS One. 2012;7(2):e30777. doi: 10.1371/journal.pone.0030777. Epub 2012 Feb 15.
- Results publication: PubMed 28535241Kok RM, Reynolds CF 3rd. Management of Depression in Older Adults: A Review. JAMA. 2017 May 23;317(20):2114-2122. doi: 10.1001/jama.2017.5706.
- Results publication: PubMed 24058642Kim J, Nakamura T, Kikuchi H, Sasaki T, Yamamoto Y. Co-variation of depressive mood and locomotor dynamics evaluated by ecological momentary assessment in healthy humans. PLoS One. 2013 Sep 13;8(9):e74979. doi: 10.1371/journal.pone.0074979. eCollection 2013.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Shu Huang study director
Principal Investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Chang Gung Memorial Hospital.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Shu Huang (+886 3 3281200 ext. 8539, yushuhuang1212@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraphy (time frame: Four times a year until the study is completed (up to 3 years)). 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 NCT05852912, which also lists 26 linked publications.
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 10 May 2023.