Dementia5-DNCT06437132
Decoding Death and Dying in People With Dementia by Digital Thanotyping
An observational study of Dementia, run by University of Bergen at 1 site in Norway.
Trial summary
How can healthcare professionals recognize that a person with dementia is at the end of life? When people are dying, their physical, mental, and social abilities are gradually declining. No reliable method of predicting perceived dying currently exists although the technology is available (sensors, algorithms). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- How many people
- 270 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: nursing home residents with dementia
Who may be able to join
- Nursing home resident
- >64 years old
- People with dementia or who have a likely diagnosis of dementia
- Score of <4 on the 4 A's Test for Delirium (4AT) will be required for inclusion (no delirium)
Who cannot join
- People without dementia or cognitive impairment
- People that are considered already in a health status emergency (< 6 weeks to live)
- People that are not living in the nursing home
- People without informed/presumed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
How can healthcare professionals recognize that a person with dementia is at the end of life? When people are dying, their physical, mental, and social abilities are gradually declining. No reliable method of predicting perceived dying currently exists although the technology is available (sensors, algorithms).
The aim of Decoding Death and Dying in Dementia by Digital thanotyping (5-D) is to provide methods and tools to diagnose and describe dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now, focusing on the case of dying people with dementia as one of the most vulnerable and difficult to study groups. 5-D combines clinical assessment tools with wearable sensing technology to monitor a) pain and distressing symptoms, b) behavioral and psychological symptoms in dementia (BPSD), c) oral changes, and to decode "the point of no return" as the beginning of perceived dying.
Read more
To obtain this outcome in nursing home patients with dementia, the investigator will test the main hypothesis: from monitoring the evolution of thanotype components over time and their interdependencies, the prediction of the "point of no return" is possible. The objectives of 5-D are:
O1. Collect data using sensors and validated assessment scales. O2. Develop estimation methods for BPSD from sensor measurements. O3. Develop digital tools to capture the expression of pain. O4. Determine the relationship between breathing and oral symptoms. O5. Develop models for symptom interdependencies at the end of life and the "point of no return".
O6. Perform human-in-the-loop validation of developed tools, models, and algorithms.
The ground-breaking interdisciplinary novelty of 5-D endeavors to enhance the understanding of end-of-life underlying pain and symptoms in people with dementia. Advancing our theoretical knowledge to uncover how, when, and why perceived dying can be identified opens the doors for transferable research across several scientific fields
Read the detailed description
Decoding death and dying in people with dementia by digital thanotyping (5-D) aims to pioneer the methodology of defining perceived dying by a data- and knowledge-driven digital representation of the end-of-life trajectory and its associated processes inferred from different measurements. The investigator proposes a novel digital thanotyping approach (Greek for thánatos) defined as the moment-by-moment in-situ quantification of the individual state of the human body. In 5-D, the investigator defines the "point of no return" as the declining state from which the person with dementia does not recover and marks the beginning of the perceived dying. In this trial the investigator describes methods and tools to define dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now in one of the most difficult to access and vulnerable groups. Results will be transferable to other life-threatening diseases, relevant for hospitals and homecare services alike. The investigator hypothesizes that, from monitoring the evolution of clinical manifestations over time and their interdependencies, the prediction of the point of no return is possible.
5-D is a 5-year, multicenter, observation-analytic, longitudinal study aimed toward method development combining clinical data and information with systems modelling and systems identification. The investigator will recruit people with dementia (N=270) from the 14 Norwegian nursing homes (NH) from the Bergen Municipality, which have a cumulative capacity of >800 patients/year (out of a total of 2500 patients/year across the municipality). The recruitment pool will be extended, if necessary, to other NHs within the municipality. The investigator chooses NHs as the location for this research (instead of patient homes) because 57% of the dying population and 97% of all people with dementia in Norway die in NHs.(12) Most people in NHs present multimorbidity; among them, 52% have severe dementia (Mini-Mental-State Examination, MMSE score 0-11), 25% moderate dementia (MMSE 12-17), 16% mild dementia (18-23), and 6% no dementia (24-30).(13) Inclusion criteria: NH inhabitants >64 years, with significant cognitive impairment.(14) Exclusion criteria: people without informed/presumed consent, people already participating in other studies, people who might be distressed by sensors.
- Conditions
- Dementia
- Being tested
- No intervention
- Keywords
- end of life, dementia, nursing home, pain assessment and treatment, symptom assessment and treatment, mouth care, agitation, sleep patterns, breathing
- Medical subject headings
- Dementia, Death, Psychomotor Agitation, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
The study is observational and will not include any specific interventions other than the regular care practice that the participants receive from their care providers. The study will use a wrist-mounted smartwatch for monitoring (Garmin VivoActive5). Previous studies show acceptability toward wearable devices among persons with dementia. Moreover, the investigator will use Somnofy, VitalThings, a radar installation mounted behind the patients bed. Before starting the data collection, care staff will recognize any discomfort or distress potentially caused by the devices, in which case the relevant device will be immediately removed.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Persons with dementia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edmonton Symptom Assessment System (ESAS++)
Symptom assessment for palliative care period and the end of life period, with added items: death rattle, dyspnea, sleep disturbances, emesis specific to end of life. Likert scale 0-10; 0 indicating no symptoms and 10 is worst symptom.
Measured: Baseline and every 6.months (up to three years); When the patient is suggested to be at the end of life and is dying; ESAS will be assessed once the day.
Digital biomarker estimations
Digital biomarker estimations for behavioural and psychological disturbances (BPSD) e.g., apathy, agitation, pain, and sleep disturbances. Moreover, different types of breathing patterns (e.g., dyspnea, death rattle, lunge edema) Estimation of activity changes and selected BPSD resulting from the combined digital phenotype modeling; these estimations are experimental and "scores" will be based on analysis of found data after data collection period.
Measured: Baseline and every 6.months (up to three years), continuous up to 12 weeks if a serious health event occurs]
Secondary outcomes (5)
Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.
Personal functional daily activities such as toileting, eating, self-care, movement/ambulation, transfers, bathing. 6 sections - scoring 1-5 on each, higher score indicates greater disability.
Measured: Baseline and every 6.months (up to three years)
Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
Validated in Norwegian nursing homes, measuring symptoms of behavioral and psychological symptoms of dementia (BPSD) such as: apathy, agitation, depression, anxiety, sleep disturbance, and appetite/eating. Gives scores 1-4 (higher numbers being daily occurance) for amount, 1-3 for intensity and burden of care related to symptom for caregiver (1-5) for each symptom.
Measured: Baseline and every 6.months (up to three years)
Mobilization - Observation - Behavioral - Intensity - Dementia Pain Scale (MOBID-2)
Measurement of pain specific to a dementia population; visual analog scale alongside likert scale 0-10, 0 being no pain and 10 being the worst pain, validated with persons with dementia
Measured: Baseline and every 6.months (up to three years)
InterRai-Palliative Care (InterRai-PC)
Oral health section only/specific of the InterRai-PC, assessment of symptoms
Measured: Baseline and every 6.months (up to three years)
Oral inspection
Biological material will be collected:
- for gum and mucosal tissue status, unstimulated saliva will be collected
- for carious lesions, collection of plaque samples will be collected from 2 teeth
- oral dryness will be measured using an oral moisture-checking device
- mucosal lesions diagnosis will be obtained from clinical pictures to determine deviation from normal healthy tissues.
Measured: Baseline and every 4.months (up to three years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University, Harvard University, Yale University, Tohoku University, Bergen kommune
- Responsible party
- Principal investigator, Bettina Husebo, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437132
- Sponsor's protocol ID
- 101088414 5-D ERC-2022-CoG
- Acronym
- 5-D
- Status last verified
- Sep 2026
- First submitted
- 7 May 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding Death and Dying in People With Dementia by Digital Thanotyping
- ClinicalTrials.gov ID
- NCT06437132
- Acronym / sponsor ID
- 5-D / 101088414 5-D ERC-2022-CoG
- Conditions
- Dementia
- Keywords
- end of life, dementia, nursing home, pain assessment and treatment, symptom assessment and treatment, mouth care, agitation, sleep patterns
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Leiden University, Harvard University, Yale University, Tohoku University, Bergen kommune
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 31 May 2024 (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.
How can healthcare professionals recognize that a person with dementia is at the end of life? When people are dying, their physical, mental, and social abilities are gradually declining. No reliable method of predicting perceived dying currently exists although the technology is available (sensors, algorithms).
The aim of Decoding Death and Dying in Dementia by Digital thanotyping (5-D) is to provide methods and tools to diagnose and describe dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now, focusing on the case of dying people with dementia as one of the most vulnerable and difficult to study groups. 5-D combines clinical assessment tools with wearable sensing technology to monitor a) pain and distressing symptoms, b) behavioral and psychological symptoms in dementia (BPSD), c) oral changes, and to decode "the point of no return" as the beginning of perceived dying.
To obtain this outcome in nursing home patients with dementia, the investigator will test the main hypothesis: from monitoring the evolution of thanotype components over time and their interdependencies, the prediction of the "point of no return" is possible. The objectives of 5-D are:
O1. Collect data using sensors and validated assessment scales. O2. Develop estimation methods for BPSD from sensor measurements. O3. Develop digital tools to capture the expression of pain. O4. Determine the relationship between breathing and oral symptoms. O5. Develop models for symptom interdependencies at the end of life and the "point of no return".
O6. Perform human-in-the-loop validation of developed tools, models, and algorithms.
The ground-breaking interdisciplinary novelty of 5-D endeavors to enhance the understanding of end-of-life underlying pain and symptoms in people with dementia. Advancing our theoretical knowledge to uncover how, when, and why perceived dying can be identified opens the doors for transferable research across several scientific fields
Detailed description
Decoding death and dying in people with dementia by digital thanotyping (5-D) aims to pioneer the methodology of defining perceived dying by a data- and knowledge-driven digital representation of the end-of-life trajectory and its associated processes inferred from different measurements. The investigator proposes a novel digital thanotyping approach (Greek for thánatos) defined as the moment-by-moment in-situ quantification of the individual state of the human body. In 5-D, the investigator defines the "point of no return" as the declining state from which the person with dementia does not recover and marks the beginning of the perceived dying. In this trial the investigator describes methods and tools to define dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now in one of the most difficult to access and vulnerable groups. Results will be transferable to other life-threatening diseases, relevant for hospitals and homecare services alike. The investigator hypothesizes that, from monitoring the evolution of clinical manifestations over time and their interdependencies, the prediction of the point of no return is possible.
5-D is a 5-year, multicenter, observation-analytic, longitudinal study aimed toward method development combining clinical data and information with systems modelling and systems identification. The investigator will recruit people with dementia (N=270) from the 14 Norwegian nursing homes (NH) from the Bergen Municipality, which have a cumulative capacity of >800 patients/year (out of a total of 2500 patients/year across the municipality). The recruitment pool will be extended, if necessary, to other NHs within the municipality. The investigator chooses NHs as the location for this research (instead of patient homes) because 57% of the dying population and 97% of all people with dementia in Norway die in NHs.(12) Most people in NHs present multimorbidity; among them, 52% have severe dementia (Mini-Mental-State Examination, MMSE score 0-11), 25% moderate dementia (MMSE 12-17), 16% mild dementia (18-23), and 6% no dementia (24-30).(13) Inclusion criteria: NH inhabitants >64 years, with significant cognitive impairment.(14) Exclusion criteria: people without informed/presumed consent, people already participating in other studies, people who might be distressed by sensors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: No interventionPersons with dementia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- nursing home residents with dementia
Key inclusion criteria (4 listed)
- Nursing home resident
- >64 years old
- People with dementia or who have a likely diagnosis of dementia
- Score of <4 on the 4 A's Test for Delirium (4AT) will be required for inclusion (no delirium)
Key exclusion criteria (4 listed)
- People without dementia or cognitive impairment
- People that are considered already in a health status emergency (< 6 weeks to live)
- People that are not living in the nursing home
- People without informed/presumed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThe study is observational and will not include any specific interventions other than the regular care practice that the participants receive from their care providers. The study will use a wrist-mounted smartwatch for monitoring (Garmin VivoActive5). Previous studies show acceptability toward wearable devices among persons with dementia. Moreover, the investigator will use Somnofy, VitalThings, a radar installation mounted behind the patients bed. Before starting the data collection, care staff will recognize any discomfort or distress potentially caused by the devices, in which case the relevant device will be immediately removed. | Other | Participants |
Primary outcome
Edmonton Symptom Assessment System (ESAS++)
Time frame: Baseline and every 6.months (up to three years); When the patient is suggested to be at the end of life and is dying; ESAS will be assessed once the day.
Symptom assessment for palliative care period and the end of life period, with added items: death rattle, dyspnea, sleep disturbances, emesis specific to end of life. Likert scale 0-10; 0 indicating no symptoms and 10 is worst symptom.
Digital biomarker estimations
Time frame: Baseline and every 6.months (up to three years), continuous up to 12 weeks if a serious health event occurs]
Digital biomarker estimations for behavioural and psychological disturbances (BPSD) e.g., apathy, agitation, pain, and sleep disturbances. Moreover, different types of breathing patterns (e.g., dyspnea, death rattle, lunge edema) Estimation of activity changes and selected BPSD resulting from the combined digital phenotype modeling; these estimations are experimental and "scores" will be based on analysis of found data after data collection period.
5 secondary outcomes
Activities of Daily Living (ADL) - Physical Self Maintenance Scale (PSMS), Lawton and Brody, 1969.
Time frame: Baseline and every 6.months (up to three years)
Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)
Time frame: Baseline and every 6.months (up to three years)
Mobilization - Observation - Behavioral - Intensity - Dementia Pain Scale (MOBID-2)
Time frame: Baseline and every 6.months (up to three years)
InterRai-Palliative Care (InterRai-PC)
Time frame: Baseline and every 6.months (up to three years)
Oral inspection
Time frame: Baseline and every 4.months (up to three years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by University of Bergen at 1 site in Norway.
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 4 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: enrolling by invitation, as of the sponsor's last update on 1 Oct 2026. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Edmonton Symptom Assessment System (ESAS++) (time frame: Baseline and every 6.months (up to three years); When the patient is suggested to be at the end of life and is dying; ESAS will be assessed once the day.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.