Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03119103 |
| Other study ID # |
FBS-27928 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2017 |
| Est. completion date |
February 12, 2018 |
Study information
| Verified date |
January 2021 |
| Source |
Studio 1 Labs |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Apnea, a cessation in breathing is critical condition that affects the person regardless of
age.
In infants, an apneic state occurs when there is an absence of respirations for 20 seconds
(Alvaro & Rigatto, 2012). In adults, there is a correlation between sleep apnea with
increased risks of cardiovascular health problems (Wimms, Woehrle, Ketheeswaran, Ramanan, &
Armitstead, 2016; Wu, Yuan, Wang, Sun, Liu, and Wei, 2016; Hao, Xiandao, Li, Jingwu, Jinghua,
& Yongxiang, 2016).
The purpose of this proposed study is to investigate the reliability of a smart bed sheet's
ability to detect physiological signals such as respiratory patterns.
The study's goals are two-fold: 1) to determine the sensors' ability to detect patterns with
regards to input signals, and 2) to evaluate the efficacy of pressure sensor signals
collected in relaying respiratory rate and respiratory patterns to monitor different
thresholds of respiration rate and pattern which may include critical parameters dangerously
outside of life sustaining norms.
Description:
Sudden Infant Death Syndrome is one of the leading causes of death in infants (Hospital for
Sick Children, 2016; Children's Hospital of Philadelphia, 2016). The first few years are
crucial as many factors contribute to infants' healthy development and much of the critical
growth period occurs during sleep. Newborns spend the majority of a day sleeping, up to 16
hours (Parmelee, Shulz, & Disbrow, 1961). Infants generally breathe irregularly with
significant breath-to-breath variability and periodic breathing characterizing regular and
apneic states (Alvaro & Rigatto, 2012). However, when an abnormal rhythm or apneic period
arises, the situation becomes critical with a limited window of opportunity to save the life
of a newborn (e.g., Sudden Infant Death Syndrome or Bradycardia). An apneic state occurs when
there is an absence of respirations for 20 seconds (Alvaro & Rigatto, 2012). The
characterization of apnea can be divided into different states such as obstructive apnea,
central apnea, and mixed apnea. Emerging literature in adults indicate a correlation between
sleep apnea with increased risks of cardiovascular health problems (Wimms, Woehrle,
Ketheeswaran, Ramanan, & Armitstead, 2016; Wu, Yuan, Wang, Sun, Liu, and Wei, 2016; Hao,
Xiandao, Li, Jingwu, Jinghua, & Yongxiang, 2016). With the ultimate goal of early detection
of changes in respiratory rates and patterns, improved methods of monitoring and detection
along with sounding an alarm will allow for early intervention and potential prevention of
death or critical illness.
The study involves evaluating the sensor effectiveness on healthy human participants. The
participants will spend one night sleeping on the functional bed sheet in the Nursing
Simulation Centre at York University. Pressure signals will will be recorded during the
night, and later evaluated for the respiration rate and patterns. Hourly during sleep, the
researcher will assess and document participants' respiratory rates and patterns, and pulse
oximeter readings (which includes the oxygen saturation reading and heart rate). Audio-visual
recording of the participants during their sleep will be captured for support of the
interpretation of signal anomalies. The data collected from the functional bed sheet will be
compared to clinical grade hourly manual monitoring of the respiratory rates and patterns by
reseachers and registered nurses.
Paricipants will complete a pre-screening form prior to settling in for the night. When ready
for sleep, participants will be directed to position themselves on the bed sheet and through
a variety of different sleeping positions (back, front, right side, left side) to establish a
baseline. During sleep, the sensors on the functional bed sheet will capture participants'
movement and respiratory indicators. Hourly, the researcher will obtain the physiological
findings of respiratory rate and rhythm (obtained through observation), and heart rate and
oxygen saturation level (obtained from the pulse oximeter)
This study will be followed by a pre-clinical study conducted with infant and adult high
technology mannequins. The pre-clinical study evaluates the efficacy of the functional bed
sheet sensors to detect pressure variations, respiratory rates and patterns both within
normal and abnormal limits. Researchers will evaluate sensor data looking for signal
deviances. This phase is fundamental and will provide evidence to support the clinical study
that evaluates the effectiveness of the device on human participants.
