Obstructive Sleep Apnea (OSA)NCT02639884
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
A study testing SedLine EEG and RRa monitoring in people with Obstructive Sleep Apnea (OSA), run by Masimo Corporation at 1 site in United States.
Trial summary
Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- SedLine EEG and RRa monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Oct 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.
- Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.
Who cannot join
- ASA classification higher than III.
- Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit
- Inability to obtain any physiological, vital, demographics and real time anaesthesia data
- Subjects who have known intolerance to any of the drugs to be used according to the study protocol
- Subjects deemed not suitable for study at the discretion of the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG
Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- SedLine EEG, RRa monitoring
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedLine EEGDevice
RRa monitoringDevice
| Study group | Role | What they receive |
|---|---|---|
| Evaluation Group | Experimental | All subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring Receives: Device: SedLine EEG; Device: RRa monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected
Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals.
Measured: One visit
Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected
All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals.
Measured: One visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2017
- Study completionOct 2017
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 Obstructive Sleep Apnea (OSA)Studies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R Drover, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639884
- Sponsor's protocol ID
- DROV0007
- Status last verified
- Mar 2021
- First submitted
- 11 Dec 2015
- Last updated
- 2 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG
- ClinicalTrials.gov ID
- NCT02639884
- Acronym / sponsor ID
- DROV0007
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 28 Dec 2015 (estimated)
- Results
- Posted 2 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation Group | Experimental | Device: SedLine EEG, Device: RRa monitoringAll subjects will be enrolled into the evaluation group and will receive SedLine EEG and RRa monitoring |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.
- Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.
Key exclusion criteria (5 listed)
- ASA classification higher than III.
- Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit
- Inability to obtain any physiological, vital, demographics and real time anaesthesia data
- Subjects who have known intolerance to any of the drugs to be used according to the study protocol
- Subjects deemed not suitable for study at the discretion of the Principal Investigator.
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 |
|---|---|---|
| SedLine EEG | Device | Evaluation Group |
| RRa monitoring | Device | Evaluation Group |
Primary outcome
Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected
Time frame: One visit
Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals.
Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected
Time frame: One visit
All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
David R Drover, M.D. principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SedLine EEG and RRa monitoring in people with Obstructive Sleep Apnea (OSA), run by Masimo Corporation at 1 site in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Apr 2021. 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 United States. 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 2 Apr 2021). 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?
Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected (time frame: One visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2021.