Sleep Apnea, ObstructivePREDICTORNCT05428839
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
A study testing Pharyngeal width measurement in people with Sleep Apnea, Obstructive, run by Inspire Medical Systems, Inc. at 10 sites in United States.
Trial summary
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Pharyngeal width measurement
- How many people
- 300 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 May 2022to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient meets the indications for the Inspire Upper Airway Stimulation
- Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery.
Who cannot join
- Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement
- Any other reason the investigator deems that the patient is unfit for participation in the study.
Trial locations and contacts
10 sites in 1 country.
Mike Swierzewski contact
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Brendan McBrine, Brendan_McBrine@MEEI.HARVARD.EDU
Phillip Huyett, MD
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Lauren Kret, lauren_n_kret@rush.edu
Mahendra Shah, mahendrakumar_Shah@rush.edu
- Recruiting
Ohio State University
Columbus, Ohio, 43121
Beth Miles-Markley, beth.miles-markley@osumc.edu
Schofield Minka, MD
- Recruiting
Mason City Clinic
Mason City, Iowa, 50401
Leisel Magg, LMagg@mcclinic.com
Dnaiel Lee, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Katherine Hartley, katherine.e.hartley@vumc.org
David Kent, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kendra Troske, kendra.troske@pennmedicine.upenn.edu
Raj Dedhia, MD
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Morgan Kyser, morgan.kyser@jefferson.edu
Colin Huntley, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Tina Harrison, harrisonta@upmc.edu
Ryan Soose, MD
- Recruiting
ENT Specialty Care of MN
Saint Louis Park, Minnesota, 55404
Jenniffer Hansen, JHansen@entsc.com
Ilya Perepelitsyn, MD
- Recruiting
Valley ENT
Scottsdale, Arizona, 85260
Dr. Jordan Weiner, jweiner121@azvent.com
Jordan Weiner, MD
About this study
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.
Read the detailed description
The objective of the study is to determine whether pharyngeal width (inside of the mouth) is an appropriate measurement to predict absence of complete concentric collapse (CCC) at the soft palate
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Pharyngeal width measurement
- Keywords
- OSA
- 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.
Pharyngeal width measurementDiagnostic test
A simple, non-invasive measurement of the pharyngeal width inside each subjects mouth
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pharyngeal width to determine if there is correlation between pharyngeal width and presence or absence of complete concentric collapse at the soft palate during drug induced sleep endoscopy
Pharyngeal width will be measured in millimeters using a caliper
Measured: Baseline, prior to routine diagnostic drug induced sleep endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start11 May 2022
- Primary completion11 Jan 2024
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inspire Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428839
- Sponsor's protocol ID
- 20021-003
- Acronym
- PREDICTOR
- Status last verified
- Mar 2024
- First submitted
- 10 May 2022
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiner JS, Chio EG, Dedhia RC, Huntley CT, Hutz MJ, Huyett P, Lee DJ, LoSavio P, Perepelitsyn I, Soose RJ, Kent DT. Anthropometric Measurements Inform Complete Concentric Collapse Status in Patients With Obstructive Sleep Apnea. OTO Open. 2026 May 5;10(2):e70245. doi: 10.1002/oto2.70245. eCollection 2026 Apr-Jun.
PubMed 42095116
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05428839
- Acronym / sponsor ID
- PREDICTOR / 20021-003
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- OSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Inspire Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.
Detailed description
The objective of the study is to determine whether pharyngeal width (inside of the mouth) is an appropriate measurement to predict absence of complete concentric collapse (CCC) at the soft palate
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient meets the indications for the Inspire Upper Airway Stimulation
- Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery.
Key exclusion criteria (2 listed)
- Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement
- Any other reason the investigator deems that the patient is unfit for participation in the study.
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 |
|---|---|---|
| Pharyngeal width measurementA simple, non-invasive measurement of the pharyngeal width inside each subjects mouth | Diagnostic test | – |
Primary outcome
Measurement of pharyngeal width to determine if there is correlation between pharyngeal width and presence or absence of complete concentric collapse at the soft palate during drug induced sleep endoscopy
Time frame: Baseline, prior to routine diagnostic drug induced sleep endoscopy
Pharyngeal width will be measured in millimeters using a caliper
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Derived from this study: PubMed 42095116Weiner JS, Chio EG, Dedhia RC, Huntley CT, Hutz MJ, Huyett P, Lee DJ, LoSavio P, Perepelitsyn I, Soose RJ, Kent DT. Anthropometric Measurements Inform Complete Concentric Collapse Status in Patients With Obstructive Sleep Apnea. OTO Open. 2026 May 5;10(2):e70245. doi: 10.1002/oto2.70245. eCollection 2026 Apr-Jun.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea, Obstructive
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.
Mike Swierzewski contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharyngeal width measurement in people with Sleep Apnea, Obstructive, run by Inspire Medical Systems, Inc. at 10 sites 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 2 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: status not confirmed, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna N Bader (763-290-1174, annabader@inspiresleep.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pharyngeal width to determine if there is correlation between pharyngeal width and presence or absence of complete concentric collapse at the soft palate during drug induced sleep endoscopy (time frame: Baseline, prior to routine diagnostic drug induced sleep endoscopy). 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 NCT05428839, which also lists 1 linked publication.
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 17 Oct 2024.