Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
Public ClinicalTrials.gov record NCT06008678. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Single-Arm, Safety and Efficacy Study of the Resvent RXiBreeze™ PAP System to Treat Obstructive Sleep Apnea
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical trial is to test the automatic positive airway pressure (APAP) function of the RXiBreeze PAP System in adult subjects with obstructive sleep apnea (OSA). The main questions the study aims to answer are: 1. Is apnea-hypopnea index (AHI) detection using the RXiBreeze PAP System equivalent to apnea-hypopnea index (AHI) detection using PSG? 2. What is the responder rate using the RXiBreeze PAP System? Participants will use the APAP function of the RXiBreeze PAP System while undergoing polysomnography (PSG) for two separate nights in a sleep center. During each visit, participants will also complete two patient reported outcome questionnaires: * Epworth Sleepiness Score (ESS); and * Functional Outcomes of Sleep Questionnaire (FOSQ) short form.
Study identification
- NCT ID
- NCT06008678
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 146 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 21, 2023
- Primary completion
- Nov 21, 2023
- Completion
- Nov 28, 2023
- Last update posted
- Dec 1, 2024
2023
United States locations
- U.S. sites
- 9
- U.S. states
- 5
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Peninsula Sleep Center | Burlingame | California | 94010 | — |
| Exalt Clinical Research | Chula Vista | California | 91910 | — |
| Bay Sleep Clinic | Mountain View | California | 94040 | — |
| Innovative Sleep Centers, Inc. | Redding | California | 96003 | — |
| TriValley Sleep Center | San Ramon | California | 94583 | — |
| NeuroTrials Research | Atlanta | Georgia | 30328 | — |
| Somnos Clinical Research | Lincoln | Nebraska | 68510 | — |
| Intrepid Research | Cincinnati | Ohio | 45240 | — |
| Innovative Sleep Centers, PLLC | Tumwater | Washington | 98510 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06008678, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 1, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06008678 live on ClinicalTrials.gov.