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TerminatedNCT06217380Updated Aug 13, 2025Results posted

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

An interventional study of Masimo SafetyNet Alert (MSNA) in Opioid Use, sponsored by Masimo Corporation. Terminated at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by Masimo Corporation · Not applicable, Interventional, and Device feasibility

Why this study was terminated
Sponsor's Decision
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Opioid Use
03

In context

Lead sponsor

Masimo Corporation is the lead sponsor of 103 studies on the registry; 1 is open to participants now.

Of its 78 completed or terminated interventional studies of FDA-regulated products, 65 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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)

    Device: Masimo SafetyNet Alert (MSNA)

Interventions

  • DeviceMasimo 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2-4 weeks

  2. 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.

    Time frame: 2-4 weeks

  3. 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.

    Time frame: 2-4 weeks

07

Results

Posted Aug 13, 2025
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.

Participant flow

No staff participants were enrolled in this study prior to termination.

Participant flow — Overall Study
MilestoneMasimo SafetyNet Alert (MSNA)
Started10
Completed6
Not completed4
Withdrew: Death: unrelated to the device. the subject was enrolled but did not start any study activities1
Withdrew: Physician decision1
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryEvaluation 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

Time frame:
2-4 weeks
Reported as:
Number · participants
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
participantsMasimo SafetyNet Alert (MSNA)
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program6
PrimaryEvaluation 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.

Time frame:
2-4 weeks
Reported as:
Number · incomplete studies
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
incomplete studiesMasimo SafetyNet Alert (MSNA)
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program4
PrimaryEvaluation 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.

Time frame:
2-4 weeks
Reported as:
Number · lost components
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program
lost componentsMasimo SafetyNet Alert (MSNA)
Evaluation of Feasibility of Masimo SafetyNet Alert (MSNA) in a Supportive Housing Program0

Adverse events

Collected over Entirety of study (60 days). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Masimo SafetyNet Alert (MSNA)1/10 (10%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Masimo SafetyNet Alert (MSNA)
<=18 years0
Between 18 and 65 years10
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Masimo SafetyNet Alert (MSNA)
Female4
Male6
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Masimo SafetyNet Alert (MSNA)
08

Study locations

1 site
  • Research Site
    Vanier, Canada
09

References and documents

Study documents

  • Study protocol · Nov 14, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06217380
Lead sponsor
Masimo Corporation
Responsible party
Sponsor
First posted
Jan 22, 2024
Start date
Sep 20, 2023
Primary completion
Feb 15, 2024
Completion
Feb 15, 2024
Results posted
Aug 13, 2025
Last update
Aug 13, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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