Functional Bed Sheet Capturing Pressure Variation and Respiratory Effort Over Time

• ClinicalTrials.gov Identifier: NCT03119103
• Recruitment Status: Unknown
• First Posted: April 18, 2017
• Last Update Posted: December 13, 2017
• Sponsor: Studio 1 Labs
• Collaborator: York University
• Information provided by (Responsible Party): Studio 1 Labs

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Olivia Lin, Ph.D.; 647-273-7973; olivia@studio1labs.com

Contact: Edward Shim; 416-821-7825; edward@studio1labs.com

Locations

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

• Principal Investigator: Laura Nicholson, EdD; York University

More Information

• Responsible Party: Studio 1 Labs
• ClinicalTrials.gov Identifier: NCT03119103
• Other Study ID Numbers: FBS-27928
• First Posted: April 18, 2017
• Last Update Posted: December 13, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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