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

A study testing Masimo SafetyNet Alert (MSNA) in people with Opioid Use, run by Masimo Corporation at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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 Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Opioid Use
What is being tested?: Masimo SafetyNet Alert (MSNA)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteCanada
Study dates: 20 Sep 2023to 15 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Research Site
Vanier

Other trials in Canada

About this study

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
Being tested: Masimo SafetyNet Alert (MSNA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06217380
Study group	Role	What they receive
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) Receives: Device: Masimo SafetyNet Alert (MSNA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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.
Measured: 2-4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 202315 Feb 2024

First posted22 Jan 2024
Study start20 Sep 2023
Primary completion15 Feb 2024
Study completion15 Feb 2024

Why it stopped: Sponsor's Decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06217380
Sponsor's protocol ID: SAFE0004
Status last verified: Jul 2025
First submitted: 14 Nov 2023
Last updated: 13 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid Use trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
ClinicalTrials.gov ID: NCT06217380
Acronym / sponsor ID: SAFE0004
Conditions: Opioid Use
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor's Decision
Enrolment: 10 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 20 Sep 2023 (actual)
Primary completion: 15 Feb 2024 (actual)
Study completion: 15 Feb 2024 (actual)
First posted: 22 Jan 2024 (actual)
Results: Posted 13 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Masimo SafetyNet Alert (MSNA)	Experimental	Device: 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Masimo SafetyNet Alert (MSNA)

Primary outcome

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
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.
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.

Results and safety

Results posted to the registry on 13 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Masimo SafetyNet Alert (MSNA)	10	6

Primary outcome: Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

Time frame: 2-4 weeks. Number. Unit: participants

Measure	Masimo SafetyNet Alert (MSNA) n = 10
Value	6

Population analysed: 4 out of the 10 subjects were not completed due to physician decision, withdrawal by subject, or by death (unrelated to device, subject never participated in any study activities)

Primary outcome: Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

Time frame: 2-4 weeks. Number. Unit: incomplete studies

Measure	Masimo SafetyNet Alert (MSNA) n = 10
Value	4

Primary outcome: Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program

Time frame: 2-4 weeks. Number. Unit: lost components

Measure	Masimo SafetyNet Alert (MSNA) n = 6
Value	0

Adverse events

Time frame: Entirety of study (60 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Masimo SafetyNet Alert (MSNA)	0 of 10 (0%)	0 of 10 (0%)	1 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Opioid Use

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
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Recruiting
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Opioid Use Disorder, Opioid Misuse

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Masimo SafetyNet Alert (MSNA) in people with Opioid Use, run by Masimo Corporation at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program (time frame: 2-4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06217380.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.