SleepBEDEXITNCT01774708
Predict Near Future Initiation of Bed Exit
An observational study of Sleep, run by Atlanta VA Medical Center at 1 site in United States.
Trial summary
Presence/absence in bed along with heartbeat, respiration, and gross motion in bed will be measured in 48 Budd Terrace residents, a long-term care facility of Emory Healthcare. Measurement will be done using only pressure-sensitive mats that lie underneath the mattress and never touch the patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Pressure sensitive pad
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Mar 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be up to 60 ambulatory Budd Terrace residents.
Who may be able to join
- Ambulatory patient able to leave the bed.
- Willingness to consent and participate in a 30-night study
Who cannot join
- Lack of capacity to consent, without an identifiable surrogate.
- Terminal Prognosis
- Unstable health, as determined by the principal investigator, medical doctor, or registered nurse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predict Near Future Initiation of Bed Exit to Prompt Effective Intervention to Avoid Nighttime Falls With Pattern-recognition Algorithms Using Unobtrusive Monitoring of Movement and Vital Signs
Presence/absence in bed along with heartbeat, respiration, and gross motion in bed will be measured in 48 Budd Terrace residents, a long-term care facility of Emory Healthcare. Measurement will be done using only pressure-sensitive mats that lie underneath the mattress and never touch the patient. PHI information will be collected by Emory staff. This PHI will be restricted to: age at time of participation; medical conditions; and medications. The PHI will be stored in a locked file behind a locked door. Data management will provide a unique identifier for each participant linked to a name that will be kept separately from the aggregate data.
The data collected from the bed sensor will be processed offline and separately from the PHI to do proof of concept evaluation for the use of machine learning technology to predict bed exits 1 to 5 minutes ahead of time.
Read the detailed description
Falls and fall-related injuries are the leading cause of injury deaths among older adults. This proposal will help prevent falls at night by developing a new alarm system. Current bed-exit alarm systems sound when the patient is half way out of the bed or on the ground. We need a warning for when a patient is about to try to exit the bed.
The investigators believe that patients' heart rate or breathing changes before they leave bed. They may also start moving within the bed. This is a brief study with nursing home patient participants. Our primary outcome of interest is bed-exits, and up to 10 participants at a time will be monitored for an average of 6 weeks (less than their anticipated stay) until which time that 250 bed exits have been recorded. Nearly all participants will have physical and/or mental impairments and will be at high risk for falling.
The investigators will use an investigational device to watch over the patient using a pad under the mattress. This monitor is called the "Early-Sense 5". The system works like a microphone for very low sounds. It changes heart, lungs, and movement vibrations into tiny electrical signals. A wire carries these signals to a control box.
The information collected in the box will be stored and checked later. We will use five different math descriptions for recognizing patterns. One or more of these may be useful to give a 1 - 5 minute early warning that the patient is about to exit the bed.
The plan is to determine whether patterns of differences in three areas (heart rate, breathing rate, and body movement) can be recognized and depended on to warn us about bed-exits or attempted bed-exits.
There are four study targets. The first is to develop five possible mathematical descriptions. The second is to use the rest of the information to test which of the descriptions have meaningful ability to predict that a patient is about to get out of bed. The third is to show that warning times are one to five minutes. The fourth is to test the best mathematical descriptions for false alarms and true fall prevention.
How doable Phase I is will depend on how well we can predict that a patient is about to get out of bed. If we can identify a pattern easily, then Phase II research will be put forward.
This study is supported by the National Institute on Aging (SBIR-I).
- Conditions
- Sleep
- Being tested
- Pressure sensitive pad
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure sensitive padDevice
Also called THE EMFIIT MOVEMENT MONITOR
The proposed research uses an investigational device from EarlySense consisting of a pressure sensitive piezoelectric pad 350 mm x 226 mm x 12 mm or a little less than 9 by 13 inches and under a half inch thick connected to a cord resembling a phone cord to a controller 10.3 by 10.5 by 5.5 inches which in turn plugs into a standard electrical outlet. The power cord is modu¬lar, so it is possible to select a cord that is long enough without having excessive extra length. The con¬nec¬tion between the pad and the monitor has a quick release like a modular telephone.
This system is designed to very unobtrusively collect heartbeat patterns, respiratory patterns, motion in bed, and bed-exit data with no risk or inconvenience to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Bed Exit | Participants will be up to 60 ambulatory Budd Terrace residents.
Inclusion/Exclusion:
Inclusion:
1. Ambulatory patient able to leave the bed.
2. Willingness to consent and participate in a 30-night study
Exclusion:
1. Lack of capacity to consent, without an identifiable surrogate.
2. Terminal Prognosis
3. Unstable health, as determined by the principal investigator, medical doctor, or registered nurse. Receives: Device: Pressure sensitive pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bed Exit
Measurements on respiratory rate, pulse, bed movement and bed presence will be collected continously during subjects' participation. Data epochs for analysis might be as short as 1 second. Data collection will be done via the pressure-sensitive mats that lie underneath the mattress and never touch the patient. PHI information will be collected and maintained by Emory staff.
Measured: Data collected continuously from monitors for up to 24 weeks will be downloaded to a secure server or flash drive approximately once a week, either wirelessly from outside the room or while the patient is outside the room for other reasons.
Bed Exit
A pizo-electric mat will detect the presence or absence of a body in the bed.
Measured: Monitored continuously for up to 24 weeks
Secondary outcomes (1)
Movement in bed
Movement in bed is assessed by a pizo-electric mat, and used as a predictor variable in analysis for bed exit.
Measured: Measured continuously while a patient is in bed for 24 hours per day up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startDec 2012
- Primary completion28 Feb 2013
- Study completionMar 2014
Why it stopped: Difficulty in recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlanta VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Theodore Johnson II, M.D., M.P.H., Atlanta VA Medical Center
- Investigators
- Thomas Whalen, Principal investigator, CDIC, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774708
- Sponsor's protocol ID
- 1R21EB015943-01
- Other IDs
- 0664699330000, R43AG042237-01
- Acronym
- BEDEXIT
- Status last verified
- Sep 2021
- First submitted
- 21 Dec 2012
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vandenberg AE, van Beijnum BJ, Overdevest VGP, Capezuti E, Johnson TM 2nd. US and Dutch nurse experiences with fall prevention technology within nursing home environment and workflow: A qualitative study. Geriatr Nurs. 2017 Jul-Aug;38(4):276-282. doi: 10.1016/j.gerinurse.2016.11.005. Epub 2016 Dec 10.
PubMed 27956058Johnson TM, Capezuti E, Whalen T, Vandenberg AE, Taylor T, Cohen M. Predicting resident bed exits in long-term care. Journal of the American Geriatrics Society. 2016; 64(S1): S183.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predict Near Future Initiation of Bed Exit to Prompt Effective Intervention to Avoid Nighttime Falls With Pattern-recognition Algorithms Using Unobtrusive Monitoring of Movement and Vital Signs
- ClinicalTrials.gov ID
- NCT01774708
- Acronym / sponsor ID
- BEDEXIT / 1R21EB015943-01
- Conditions
- Sleep
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting participants
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Atlanta VA Medical CenterUS federal agency
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2012
- Primary completion
- 28 Feb 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Jan 2013 (estimated)
- 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.
Presence/absence in bed along with heartbeat, respiration, and gross motion in bed will be measured in 48 Budd Terrace residents, a long-term care facility of Emory Healthcare. Measurement will be done using only pressure-sensitive mats that lie underneath the mattress and never touch the patient. PHI information will be collected by Emory staff. This PHI will be restricted to: age at time of participation; medical conditions; and medications. The PHI will be stored in a locked file behind a locked door. Data management will provide a unique identifier for each participant linked to a name that will be kept separately from the aggregate data.
The data collected from the bed sensor will be processed offline and separately from the PHI to do proof of concept evaluation for the use of machine learning technology to predict bed exits 1 to 5 minutes ahead of time.
Detailed description
Falls and fall-related injuries are the leading cause of injury deaths among older adults. This proposal will help prevent falls at night by developing a new alarm system. Current bed-exit alarm systems sound when the patient is half way out of the bed or on the ground. We need a warning for when a patient is about to try to exit the bed.
The investigators believe that patients' heart rate or breathing changes before they leave bed. They may also start moving within the bed. This is a brief study with nursing home patient participants. Our primary outcome of interest is bed-exits, and up to 10 participants at a time will be monitored for an average of 6 weeks (less than their anticipated stay) until which time that 250 bed exits have been recorded. Nearly all participants will have physical and/or mental impairments and will be at high risk for falling.
The investigators will use an investigational device to watch over the patient using a pad under the mattress. This monitor is called the "Early-Sense 5". The system works like a microphone for very low sounds. It changes heart, lungs, and movement vibrations into tiny electrical signals. A wire carries these signals to a control box.
The information collected in the box will be stored and checked later. We will use five different math descriptions for recognizing patterns. One or more of these may be useful to give a 1 - 5 minute early warning that the patient is about to exit the bed.
The plan is to determine whether patterns of differences in three areas (heart rate, breathing rate, and body movement) can be recognized and depended on to warn us about bed-exits or attempted bed-exits.
There are four study targets. The first is to develop five possible mathematical descriptions. The second is to use the rest of the information to test which of the descriptions have meaningful ability to predict that a patient is about to get out of bed. The third is to show that warning times are one to five minutes. The fourth is to test the best mathematical descriptions for false alarms and true fall prevention.
How doable Phase I is will depend on how well we can predict that a patient is about to get out of bed. If we can identify a pattern easily, then Phase II research will be put forward.
This study is supported by the National Institute on Aging (SBIR-I).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bed Exit | – | Device: Pressure sensitive padParticipants will be up to 60 ambulatory Budd Terrace residents. Inclusion/Exclusion: Inclusion: 1. Ambulatory patient able to leave the bed. 2. Willingness to consent and participate in a 30-night study Exclusion: 1. Lack of capacity to consent, without an identifiable surrogate. 2. Terminal Prognosis 3. Unstable health, as determined by the principal investigator, medical doctor, or registered nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be up to 60 ambulatory Budd Terrace residents.
Key inclusion criteria (2 listed)
- Ambulatory patient able to leave the bed.
- Willingness to consent and participate in a 30-night study
Key exclusion criteria (3 listed)
- Lack of capacity to consent, without an identifiable surrogate.
- Terminal Prognosis
- Unstable health, as determined by the principal investigator, medical doctor, or registered nurse.
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 |
|---|---|---|
| Pressure sensitive padAlso: THE EMFIIT MOVEMENT MONITORThe proposed research uses an investigational device from EarlySense consisting of a pressure sensitive piezoelectric pad 350 mm x 226 mm x 12 mm or a little less than 9 by 13 inches and under a half inch thick connected to a cord resembling a phone cord to a controller 10.3 by 10.5 by 5.5 inches which in turn plugs into a standard electrical outlet. The power cord is modu¬lar, so it is possible to select a cord that is long enough without having excessive extra length. The con¬nec¬tion between the pad and the monitor has a quick release like a modular telephone. This system is designed to very unobtrusively collect heartbeat patterns, respiratory patterns, motion in bed, and bed-exit data with no risk or inconvenience to the patient. | Device | Bed Exit |
Primary outcome
Bed Exit
Time frame: Data collected continuously from monitors for up to 24 weeks will be downloaded to a secure server or flash drive approximately once a week, either wirelessly from outside the room or while the patient is outside the room for other reasons.
Measurements on respiratory rate, pulse, bed movement and bed presence will be collected continously during subjects' participation. Data epochs for analysis might be as short as 1 second. Data collection will be done via the pressure-sensitive mats that lie underneath the mattress and never touch the patient. PHI information will be collected and maintained by Emory staff.
Bed Exit
Time frame: Monitored continuously for up to 24 weeks
A pizo-electric mat will detect the presence or absence of a body in the bed.
1 secondary outcome
Movement in bed
Time frame: Measured continuously while a patient is in bed for 24 hours per day up to 24 weeks
Results and safety
The study was stopped early (reason given: Difficulty in recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Background: PubMed 27956058Vandenberg AE, van Beijnum BJ, Overdevest VGP, Capezuti E, Johnson TM 2nd. US and Dutch nurse experiences with fall prevention technology within nursing home environment and workflow: A qualitative study. Geriatr Nurs. 2017 Jul-Aug;38(4):276-282. doi: 10.1016/j.gerinurse.2016.11.005. Epub 2016 Dec 10.
- Results publicationJohnson TM, Capezuti E, Whalen T, Vandenberg AE, Taylor T, Cohen M. Predicting resident bed exits in long-term care. Journal of the American Geriatrics Society. 2016; 64(S1): S183.
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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.
Thomas Whalen principal investigator
CDIC, Inc
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 Sleep, run by Atlanta VA Medical Center at 1 site in United States.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 Sep 2021. 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 United States. 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 was stopped early (reason given: Difficulty in recruiting participants). Results are not available in the source record.
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?
Bed Exit (time frame: Data collected continuously from monitors for up to 24 weeks will be downloaded to a secure server or flash drive approximately once a week, either wirelessly from outside the room or while the patient is outside the room for other reasons.). 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?
On the ClinicalTrials.gov record for NCT01774708, which also lists 2 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 16 Sep 2021.