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Functional Bed Sheet Capturing Pressure Variation and Respiratory Effort Over Time

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119103
Recruitment Status : Unknown
Verified December 2017 by Studio 1 Labs.
Recruitment status was:  Recruiting
First Posted : April 18, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
York University
Information provided by (Responsible Party):
Studio 1 Labs

Brief 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.


Condition or disease Intervention/treatment Phase
Apnea Respiration Device: Functional Bed Sheet Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Functional Bed Sheet Capturing Respiratory Effort
Estimated Study Start Date : December 13, 2017
Estimated Primary Completion Date : February 15, 2018
Estimated Study Completion Date : August 30, 2018

Arm Intervention/treatment
Intervention of Functional Bed Sheet
Interventions will be non-invasive where healthy adults (over the age of 17, 10 male and 10 female) sleeps on the functional bed sheet overnight.
Device: Functional Bed Sheet
All participants sleep on the functional bed sheet that is placed under a normal bed sheet. The device collects pressure sensor information and informs on body position, respiration rate, and respiration patterns.




Primary Outcome Measures :
  1. Apnea [ Time Frame: Up to 1 year ]
    Through Pressure Sensor Variation and with algorithms detecting respiration patterns and respiration rate from Functional Bed Sheet


Secondary Outcome Measures :
  1. Sleeping Position [ Time Frame: Up to 1 year ]
    Through Pressure Sensor Variation and with algorithms detecting Sleeping Position from the Functional Bed Sheet



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • no known sleep-related disorders
  • use of sleep medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119103


Contacts
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Contact: Olivia Lin, Ph.D. 647-273-7973 olivia@studio1labs.com
Contact: Edward Shim 416-821-7825 edward@studio1labs.com

Locations
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Canada, Ontario
York University Recruiting
Toronto, Ontario, Canada, M3J 1P3
Contact: Laura Nicholson, RN, BScN, MN, EdD, CHSE    416-736-2100 ext 33398    nicholsl@yorku.ca   
Principal Investigator: Laura Nicholson, RN, BScN, MN, EdD, CHSE         
Sponsors and Collaborators
Studio 1 Labs
York University
Investigators
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Principal Investigator: Laura Nicholson, EdD York University
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Responsible Party: Studio 1 Labs
ClinicalTrials.gov Identifier: NCT03119103    
Other Study ID Numbers: FBS-27928
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Studio 1 Labs:
respiratory pattern
sensor data
bed sheet
pressure
respiration rate