Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

Opioid Use Clinical Trial

Official title:

Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06217380
• Other study ID #: SAFE0004
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: April 2024
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Clinical Trial will evaluate the Feasibility and Acceptability of Oxygen Saturation Monitoring using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Client Participants:

• Participants who are18 years of age or greater

• Participants housed within a supportive housing program who intend to inject opioids

• Participants who have given verbal informed consent to participate in the study

Inclusion Criteria for Staff Participants:

• Participant is research staff and/or Rita Thompson Residence staff

• Participant is willing to give implied consent by reading and completing the staff survey

Exclusion Criteria for Client Participants:

• Participants deemed not suitable for the study at the discretion of the principal investigator, research staff or housing program nurses/staff

• Participants with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as psoriasis, eczema, angioma, burns, scar tissue, substantial skin breakdown, nail polish, acrylic nails, infections, or other abnormalities that may interfere with MSNA functioning

• Participants with known allergic reactions to foam/rubber products and/or adhesive tape

Exclusion Criteria for Staff Participants:

-None

Related Conditions & MeSH terms

• Opioid Use

Intervention

Device:
• Masimo SafetyNet Alert (MSNA)
This study will explore the feasibility of implementing the Masimo SafetyNet Alert (MSNA) oxygen saturation monitoring system and the acceptance of MSNA by individuals living in a supportive housing program, who inject opioids.

Locations

Country	Name	City	State
Canada	Research Site	Vanier

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program	Summarizing the recruitment rate to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program.	2-4 weeks
Primary	Evaluation of feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program	Summarizing proportion of incomplete studies to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program.	2-4 weeks
Primary	Evaluation of feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program	Summarizing proportion of lost components to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program.	2-4 weeks
Primary	Evaluation of acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program	Summarizing the recruitment rate to evaluate the acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program.	2-4 weeks
Primary	Evaluation of acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program	Summarizing the proportion of incomplete studies to evaluate the acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program.	2-4 weeks
Primary	Evaluation of acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program	Summarizing the proportion of lost components to evaluate the acceptability of Masimo SafetyNet Alert (MSNA) in a supportive housing program.	2-4 weeks
Primary	Evaluation of integration and expansion of Masimo SafetyNet Alert (MSNA) to similar housing environments	Summarizing the recruitment rate to evaluate the integration and expansion of Masimo SafetyNet Alert (MSNA) to similar housing environments.	2-4 weeks
Primary	Evaluation of integration and expansion of Masimo SafetyNet Alert (MSNA) to similar housing environments	Summarizing the proportion of incomplete studies to evaluate the integration and expansion of Masimo SafetyNet Alert (MSNA) to similar housing environments.	2-4 weeks