- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217380
Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
July 25, 2025 updated by: Masimo Corporation
This Clinical Trial will evaluate the Feasibility and Acceptability of Oxygen Saturation Monitoring using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Vanier, Canada
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Masimo SafetyNet Alert (MSNA)
All subjects who are enrolled into the test group (excluding staff participants) and participate in data collection receive the noninvasive 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Time Frame: 2-4 weeks
|
Number of participants who demonstrated feasibility of MSNA in a supportive housing program
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2-4 weeks
|
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Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
Time Frame: 2-4 weeks
|
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
Time Frame: 2-4 weeks
|
Summarizing proportion of lost components to evaluate the feasibility of Masimo SafetyNet Alert (MSNA) in a supportive housing program.
|
2-4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2023
Primary Completion (Actual)
February 15, 2024
Study Completion (Actual)
February 15, 2024
Study Registration Dates
First Submitted
November 14, 2023
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
August 13, 2025
Last Update Submitted That Met QC Criteria
July 25, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- SAFE0004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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