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

NCT06217380 | Terminated Results FDA Device

• 1 other identifier: SAFE0004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (3)

• Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

  Number of participants who demonstrated feasibility of MSNA in a supportive housing program

  2-4 weeks

• 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

• 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

Study Arms (1)

Masimo SafetyNet Alert (MSNA)

EXPERIMENTAL

All subjects who are enrolled into the test group (excluding staff participants) and participate in data collection receive the noninvasive Masimo SafetyNet Alert (MSNA)

Device: Masimo SafetyNet Alert (MSNA)

Interventions

Masimo SafetyNet Alert (MSNA) DEVICE

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.

Masimo SafetyNet Alert (MSNA)

Eligibility Criteria

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

You may qualify if:

• 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
• Participant is research staff and/or Rita Thompson Residence staff
• Participant is willing to give implied consent by reading and completing the staff survey

You may not qualify if:

• 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
• None

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Research Site

Vanier, Canada

Location

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Some outcome measures could not be calculated due to small number of subjects being analyzed. No staff participants were enrolled in this study prior to termination.

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo

clinicalresearchdept@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: January 22, 2024
• Study Start: September 20, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-07

Locations

CA (1)