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NCT05445869 · ClinicalTrials.gov registry record · NA
Severe OSA Study (SOS)
A NA study, sponsored by ProSomnus Sleep Technologies.
- Terminated
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT05445869: Clinical Trial NA study, sponsored by ProSomnus Sleep Technologies.
NCT05445869 is a NA study that was terminated before completion, run by ProSomnus Sleep Technologies. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05445869, a NA study, was terminated before completion, sponsored by ProSomnus Sleep Technologies.
- TERMINATED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.
Primary Outcome
The AHI co-primary effectiveness endpoint is to demonstrate a responder rate significantly greater than 50%; responders will be defined as individuals who achieve an AHI \< 15 h-1 with the EVO Sleep and Snore Device 6 months after initiation of the therapy.
Interventions
- DEVICE ProSomnus® EVO Sleep and Snore Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2024-02-15 |
| Phase | NA |
Why NCT05445869 stopped before completion
NCT05445869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which ProSomnus® EVO Sleep and Snore Device is the first listed.
NCT05445869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05445869 about?
NCT05445869 is a clinical study titled "Severe OSA Study (SOS)". This study is a prospective, multi-center, single-arm, open-label study evaluating the safety and effectiveness of therapy with the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.
What is the current status of trial NCT05445869?
This trial is currently terminated. It is a NA study. The enrollment target is 35 participants. The study started on 2022-09-12. Estimated completion is 2024-02-15.
What interventions are being tested in trial NCT05445869?
The interventions under investigation include: ProSomnus® EVO Sleep and Snore Device (DEVICE).
Who is sponsoring clinical trial NCT05445869?
This trial is sponsored by ProSomnus Sleep Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05445869's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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