Functional Bed Sheet Capturing Pressure Variation and Respiratory Effort Over Time

NCT03119103 | Completed

• 1 other identifier: FBS-27928
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea; Respiration

Keywords

respiratory pattern; sensor data; bed sheet; pressure; respiration rate

Outcome Measures

Primary Outcomes (1)

• Apnea

  Through Pressure Sensor Variation and with algorithms detecting respiration patterns and respiration rate from Functional Bed Sheet

  Up to 1 year

Secondary Outcomes (1)

• Sleeping Position

  Up to 1 year

Study Arms (1)

Intervention of Functional Bed Sheet

OTHER

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

Interventions

Functional Bed Sheet DEVICE

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.

Intervention of Functional Bed Sheet

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Studio 1 Labs: lead
• York University: collaborator

Study Sites (1)

York University

Toronto, Ontario, M3J 1P3, Canada

Location

MeSH Terms

Conditions

Apnea; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Laura Nicholson, EdD

  York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 18, 2017
• Study Start: December 13, 2017
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

CA (1)