Ignite Creation Date:
2024-05-06 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03640416
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2018-08-15
Brief Title:
The Feasibility to Use Wearable Devices to Collect Physiologic Data During Night Shifts - A Pilot Study
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
The Feasibility to Use Wearable Devices to Collect Physiologic Data During Night Shifts - A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is an increase interest in the use of wearable activity trackers and wearable technology in the various medical fields Such devices can increase physical activity and decrease weight significantly
Field and laboratory studies have shown that shift work can alter circadian rhythms disrupt the sleep cycle and hinder human performance Sleep deprivation reduces alertness level and may increase reaction time cause memory impairment and impaired motor skills Disrupted circadian rhythms a well-known consequence of atypical work schedules have been linked to neurodegeneration
The aim of this pilot study is to evaluate the feasibility of wearable devices to collect data on physiologic parameters during sleep and awake under stress conditions
The study population will include 30 Rambam Health Care Campus medical residents who work nights on call The length of experiment per participant will be one month
Subjective data on stress will be collected during the study Data on vital signs and sleep stages will be collected through a smart watch Fitbit Charge HR
Field and laboratory studies have shown that shift work can alter circadian rhythms disrupt the sleep cycle and hinder human performance Sleep deprivation reduces alertness level and may increase reaction time cause memory impairment and impaired motor skills Disrupted circadian rhythms a well-known consequence of atypical work schedules have been linked to neurodegeneration
The aim of this pilot study is to evaluate the feasibility of wearable devices to collect data on physiologic parameters during sleep and awake under stress conditions
The study population will include 30 Rambam Health Care Campus medical residents who work nights on call The length of experiment per participant will be one month
Subjective data on stress will be collected during the study Data on vital signs and sleep stages will be collected through a smart watch Fitbit Charge HR
Detailed Description:
Background There is an increase interest in the use of wearable activity trackers and wearable technology in the various medical fields Such devices can increase physical activity and decrease weight significantly
Shift work is usually referred to as dividing working hours among two or more occupational groups in order to cover the time needed for duty performance or for production process and shift workers perform duties outside the regular working hours
Field and laboratory studies have shown that shift work can alter circadian rhythms disrupt the sleep cycle and hinder human performance Sleep deprivation reduces alertness level and may increase reaction time cause memory impairment and impaired motor skills Disrupted circadian rhythms a well-known consequence of atypical work schedules have been linked to neurodegeneration
Aim
A pilot study to evaluate the feasibility of wearable devices to collect data on physiologic parameters during sleep and awake under stress conditions night shifts
Secondary objective To assess physiological parameters collected by wearable devices This study will help us assess the contribution of wearable devices to collect Big Data for future clinical studies
Study design
This is a prospective pilot study The study population will include 30 Rambam Health Care Campus medical residents who work nights on call not restricted to emergency departments
A mobile phone application has been developed for the study The application will be installed on each participants smart phone with Android operating system and it will collect data on number of calls and SMS received during a night on call
The participant will register to the mobile application without the need for a mobile number or e-mail address The data collected will not be linked to a phone number or other personal information Only the investigators of the Pediatric Pulmonology institute will have access to the data collected by the mobile application
Only the data on number of calls and SMS will be collected during a night on call The data will not include the content of the calls or SMS or the phone number of the sender or receiver of the calls and SMS
Vital signs and data on sleep quality will be collected through a wearable device which interacts with the mobile application The wearable device used will be the Fitbit Charge HR Recent studies have shown that this wearable device provides an accurate measurement of heart rate during walking and running activities and energy expenditure The device has been shown to have high accuracy in sleep evaluation and circadian rest-activity rhythm measurement 8
The Fitbit Charge HR collects data on
Continuous heart rate monitoring heart beats per minute BPM average resting heart rate and time spent in heart-rate zones
Sleep stages light deep and REM Rapid Eye Movement sleep and auto sleep tracking
Periods of time stationary vs active walked at least 250 steps
Steps taken
Distance covered
Calories burned The Fitbit Charge HR is a commercial product widely used worldwide and data from the device is sent to a secured online server and can be accessed by each user to see only data collected from his own device
Each participant will provide written informed consent including
1 Approval to join the experiment
2 Information on Age gender height
3 Telephone number
4 Approval to collect time of SMS and phone calls
5 Approval to provide all data collected from the wearable device
6 Approval to collect hair and blood sample It should be emphasized that all data on each participant will be collected anonymously and no data will be provided to the health management of Rambam or any 3rd party
Each participant will be given a coded name starting STR1 STR2 etc and only the principal investigator will have access to the real name and ID numbers of the participants In addition no genetic testing will be performed on hair or blood samples
Visit 1 - recruitment
At the beginning of the experiment each participant will schedule a at 9-10 am with an investigator in which the participant will
receive detailed information about the study including data collection privacy and security issues
sign an informed consent form
provide a table of nights on call for the month of the experiment
receive the activity wearable device and instructions on its functionality and requirements
provide demographic information
Assess baseline stress level
Provide a hair sample 05 gr for cortisol measurements
Complete PSS - Perceived Stress Scale questionnaire 12
Provide a blood test 6 ml to evaluate stress hormones and specific cytokines for assessing stress The serums will be stored and for any future use an amendment will be submitted to the Rambam helsinky committee
Digit-span test - measures working memorys number storage capacity The participant hears a sequence of numerical digits and is asked to recall the sequence correctly with increasingly longer sequences being tested in each trial The participants span is the longest number of sequential digits that can accurately be remembered
PASAT - Paced Auditory Serial Addition Test - measures capacity and rate of information processing and sustained and divided attention The participant is given a number every 3 seconds and is asked to add the number he just heard with the number he heard before
Trail Making test - cellular application that provides information about visual search speed scanning The test consists of two parts in the first the targets are all numbers 1 2 3 etc and the test taker needs to connect them in sequential order in the second part the subject alternates between numbers and letters 1 A 2 B etc
Data collection during month of participation
Around each night on call of a participant
1 From 24 hours before the night on call Charge and wear the wearable It is preferred that participants wear the device continuously throughout the month except when charging
2 During the night on call
Continuous tracking of vitals steps sleep time and quality will be recorded
1-4 SMS messages will be sent randomly by one of the investigators of the Pediatric Pulmonology institute asking the participant to send a number between 1 and 5 indicating their subjective stress 1 means no stress and 5 means very stressed Data will be collected by the investigator no data will be saved on a remote server
3 From night on call end until 24 hours later continue wearing the wearable device
4 24 hours after the end of night on call 1000 in the morning respond to a message from one of the investigators to provide subjective stress level
Visit 2
5 Immediately after one of the nights on call 900-1000 in the morning
1 Participants will complete a second PSS - Perceived Stress Scale questionnaire 9
2 Blood pressure and heart rate will be measured
3 a 5 ml blood sample will be collected
4 Digit-span test PASAT Trail Making test will be preform again The visits will be scheduled and done in the Rambam health care campus in a location and timing suitable to the participant
Data analysis After data collection we will build a statistical model that will try to estimate stress based on behavioral characteristics
Stress will be estimated using
1 Self-reports scale of 1-5 on subjective stress through random messages from the study mobile application during night on call
2 Heart rate heart rate variability blood pressure
3 Digit-span test PASAT Trail Making test before and after nightshift will be analyzed 3 Digit-span test PASAT Trail Making test will be preform again The behavioral characteristics will include
1 Length and time of sleep before during and after a shift and sleep stages tracking light deep and REM sleep 2 Interruptions SMS calls movement during wake and sleep 3 Movement during the shift time while being stationary vs active
Shift work is usually referred to as dividing working hours among two or more occupational groups in order to cover the time needed for duty performance or for production process and shift workers perform duties outside the regular working hours
Field and laboratory studies have shown that shift work can alter circadian rhythms disrupt the sleep cycle and hinder human performance Sleep deprivation reduces alertness level and may increase reaction time cause memory impairment and impaired motor skills Disrupted circadian rhythms a well-known consequence of atypical work schedules have been linked to neurodegeneration
Aim
A pilot study to evaluate the feasibility of wearable devices to collect data on physiologic parameters during sleep and awake under stress conditions night shifts
Secondary objective To assess physiological parameters collected by wearable devices This study will help us assess the contribution of wearable devices to collect Big Data for future clinical studies
Study design
This is a prospective pilot study The study population will include 30 Rambam Health Care Campus medical residents who work nights on call not restricted to emergency departments
A mobile phone application has been developed for the study The application will be installed on each participants smart phone with Android operating system and it will collect data on number of calls and SMS received during a night on call
The participant will register to the mobile application without the need for a mobile number or e-mail address The data collected will not be linked to a phone number or other personal information Only the investigators of the Pediatric Pulmonology institute will have access to the data collected by the mobile application
Only the data on number of calls and SMS will be collected during a night on call The data will not include the content of the calls or SMS or the phone number of the sender or receiver of the calls and SMS
Vital signs and data on sleep quality will be collected through a wearable device which interacts with the mobile application The wearable device used will be the Fitbit Charge HR Recent studies have shown that this wearable device provides an accurate measurement of heart rate during walking and running activities and energy expenditure The device has been shown to have high accuracy in sleep evaluation and circadian rest-activity rhythm measurement 8
The Fitbit Charge HR collects data on
Continuous heart rate monitoring heart beats per minute BPM average resting heart rate and time spent in heart-rate zones
Sleep stages light deep and REM Rapid Eye Movement sleep and auto sleep tracking
Periods of time stationary vs active walked at least 250 steps
Steps taken
Distance covered
Calories burned The Fitbit Charge HR is a commercial product widely used worldwide and data from the device is sent to a secured online server and can be accessed by each user to see only data collected from his own device
Each participant will provide written informed consent including
1 Approval to join the experiment
2 Information on Age gender height
3 Telephone number
4 Approval to collect time of SMS and phone calls
5 Approval to provide all data collected from the wearable device
6 Approval to collect hair and blood sample It should be emphasized that all data on each participant will be collected anonymously and no data will be provided to the health management of Rambam or any 3rd party
Each participant will be given a coded name starting STR1 STR2 etc and only the principal investigator will have access to the real name and ID numbers of the participants In addition no genetic testing will be performed on hair or blood samples
Visit 1 - recruitment
At the beginning of the experiment each participant will schedule a at 9-10 am with an investigator in which the participant will
receive detailed information about the study including data collection privacy and security issues
sign an informed consent form
provide a table of nights on call for the month of the experiment
receive the activity wearable device and instructions on its functionality and requirements
provide demographic information
Assess baseline stress level
Provide a hair sample 05 gr for cortisol measurements
Complete PSS - Perceived Stress Scale questionnaire 12
Provide a blood test 6 ml to evaluate stress hormones and specific cytokines for assessing stress The serums will be stored and for any future use an amendment will be submitted to the Rambam helsinky committee
Digit-span test - measures working memorys number storage capacity The participant hears a sequence of numerical digits and is asked to recall the sequence correctly with increasingly longer sequences being tested in each trial The participants span is the longest number of sequential digits that can accurately be remembered
PASAT - Paced Auditory Serial Addition Test - measures capacity and rate of information processing and sustained and divided attention The participant is given a number every 3 seconds and is asked to add the number he just heard with the number he heard before
Trail Making test - cellular application that provides information about visual search speed scanning The test consists of two parts in the first the targets are all numbers 1 2 3 etc and the test taker needs to connect them in sequential order in the second part the subject alternates between numbers and letters 1 A 2 B etc
Data collection during month of participation
Around each night on call of a participant
1 From 24 hours before the night on call Charge and wear the wearable It is preferred that participants wear the device continuously throughout the month except when charging
2 During the night on call
Continuous tracking of vitals steps sleep time and quality will be recorded
1-4 SMS messages will be sent randomly by one of the investigators of the Pediatric Pulmonology institute asking the participant to send a number between 1 and 5 indicating their subjective stress 1 means no stress and 5 means very stressed Data will be collected by the investigator no data will be saved on a remote server
3 From night on call end until 24 hours later continue wearing the wearable device
4 24 hours after the end of night on call 1000 in the morning respond to a message from one of the investigators to provide subjective stress level
Visit 2
5 Immediately after one of the nights on call 900-1000 in the morning
1 Participants will complete a second PSS - Perceived Stress Scale questionnaire 9
2 Blood pressure and heart rate will be measured
3 a 5 ml blood sample will be collected
4 Digit-span test PASAT Trail Making test will be preform again The visits will be scheduled and done in the Rambam health care campus in a location and timing suitable to the participant
Data analysis After data collection we will build a statistical model that will try to estimate stress based on behavioral characteristics
Stress will be estimated using
1 Self-reports scale of 1-5 on subjective stress through random messages from the study mobile application during night on call
2 Heart rate heart rate variability blood pressure
3 Digit-span test PASAT Trail Making test before and after nightshift will be analyzed 3 Digit-span test PASAT Trail Making test will be preform again The behavioral characteristics will include
1 Length and time of sleep before during and after a shift and sleep stages tracking light deep and REM sleep 2 Interruptions SMS calls movement during wake and sleep 3 Movement during the shift time while being stationary vs active
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None