Obstructive Sleep ApneaNCT03391141
Diagnostic Validation of Drug-Induced Sleep Endoscopy (DISE)
An observational study of Obstructive Sleep Apnea, run by Dr. Erica Thaler at 1 site in United States.
Trial summary
This study aims to validate whether the pattern of airway collapse recorded during Drug-Induced Sleep Endoscopy (DISE) mirrors that of natural sleep, and to develop a model for airway collapse. Sensors will be placed in subjects' upper airways during DISE and then during in-lab sleep studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 1 Sep 2021
- Phase
- Observational
- 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
Study population: Adult patients with moderate to severe obstructive sleep apnea who have failed a trial of CPAP.
Who may be able to join
- Patients with moderate to severe OSAS
- Must have symptoms of OSAS
- Must have sleep study showing AHI of 15 or greater
- Failed trial of CPAP
- BMI less than 35
- Be a surgical candidate for ablative or neuro-stimulation surgery
Show all 9Show fewer
- Acceptable surgical comorbidities
- Non-aberrant upper airway anatomy
- Must demonstrate reliability in keep appointments
Who cannot join
- Prior ablative airway surgeries
- Allergies to oxymetazoline or lidocaine
- Significant central sleep apnea
- Presence of other sleep disorders
- History of neurologic or neuromuscular disease
- Historical or present substance abuse
Show all 16Show fewer
- Bleeding disorders
- Autoimmune diseases that increase risk of nasal trauma such as Wegener's, Sarcoidosis, etc.
- Pregnancy
- Unacceptable anesthesia risk
- Ablative or orthognathic airway surgery
- Significant weight loss or weight gain with or without bariatric surgery
- Initiation of new drug that is known to alter sleep architecture
- Development of head and neck neoplasm
- Development of autoimmune disease altering airway anatomy
- Trauma to head and neck region
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: In Vivo Aerodynamic Modeling of the Upper Airway in OSA
This study aims to validate whether the pattern of airway collapse recorded during Drug-Induced Sleep Endoscopy (DISE) mirrors that of natural sleep, and to develop a model for airway collapse. Sensors will be placed in subjects' upper airways during DISE and then during in-lab sleep studies. The sleep study results will be compared with OR findings to create an aerodynamic model for natural sleep and to assess whether airway observations during DISE were valid representations of natural sleep.
Read the detailed description
Drug-induced sleep endoscopy (DISE) was developed in 1991 as a technique to characterize upper airway collapse in patients with OSA. With the advent of various upper airway surgeries introduced in recent years, DISE has become increasingly utilized by the sleep surgeon as a surrogate for airway collapse during natural sleep in order to tailor a surgical approach for each patient. Propofol and/or midazolam infusions are typically used for sedation in these cases, however, there is limited evidence to suggest that these anesthetics reproduce natural sleep architecture. Therefore, it cannot be assumed that the pattern of collapse observed during DISE is reflective of natural sleep.
The aim of this study is to validate whether the pattern of collapse recorded during DISE mirrors that of natural sleep. Furthermore, the investigators aim to develop a quantitative in vivo model for airway collapse in order to further our understanding of the pathophysiology of OSA. They will do this by comparing the findings from DISE with aerodynamic readings from within the upper airway during natural sleep. The proposed technique will employ technologies already approved by the FDA for clinical use. Capacitance circuitry, airflow sensors, and/or pressure transducers will be suspended within the upper aerodigestive tract along a thin, low-profile, and flexible tube. During Phase I of the study, this aerodynamic probe will be placed in the OR during DISE along the upper airway, namely in the retropalatal, retroglossal, and hypopharyngeal regions. Readings will be correlated and calibrated with DISE findings in real-time. During Phase II, these sensors will again be placed within the same patients during in-office sleep studies. The results from the sleep study will be analyzed in conjunction with OR findings in order to create an aerodynamic model for natural sleep. This will also allow the investigators to assess whether airway observations during DISE were valid representations of natural sleep.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, sleep endoscopy, drug induced sleep endoscopy, diagnostic validation
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
site of airway obstruction
the presence or absence of airway obstruction in the retropalatal, retroglossal, and hypopharyngeal areas
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start9 Apr 2018
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Erica Thaler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Erica Thaler, University of Pennsylvania
- Investigators
- Erica Thaler, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391141
- Sponsor's protocol ID
- 827621
- Status last verified
- Sep 2021
- First submitted
- 8 Dec 2017
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Aerodynamic Modeling of the Upper Airway in OSA
- ClinicalTrials.gov ID
- NCT03391141
- Acronym / sponsor ID
- 827621
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, sleep endoscopy, drug induced sleep endoscopy, diagnostic validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dr. Erica ThalerUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 5 Jan 2018 (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 aims to validate whether the pattern of airway collapse recorded during Drug-Induced Sleep Endoscopy (DISE) mirrors that of natural sleep, and to develop a model for airway collapse. Sensors will be placed in subjects' upper airways during DISE and then during in-lab sleep studies. The sleep study results will be compared with OR findings to create an aerodynamic model for natural sleep and to assess whether airway observations during DISE were valid representations of natural sleep.
Detailed description
Drug-induced sleep endoscopy (DISE) was developed in 1991 as a technique to characterize upper airway collapse in patients with OSA. With the advent of various upper airway surgeries introduced in recent years, DISE has become increasingly utilized by the sleep surgeon as a surrogate for airway collapse during natural sleep in order to tailor a surgical approach for each patient. Propofol and/or midazolam infusions are typically used for sedation in these cases, however, there is limited evidence to suggest that these anesthetics reproduce natural sleep architecture. Therefore, it cannot be assumed that the pattern of collapse observed during DISE is reflective of natural sleep.
The aim of this study is to validate whether the pattern of collapse recorded during DISE mirrors that of natural sleep. Furthermore, the investigators aim to develop a quantitative in vivo model for airway collapse in order to further our understanding of the pathophysiology of OSA. They will do this by comparing the findings from DISE with aerodynamic readings from within the upper airway during natural sleep. The proposed technique will employ technologies already approved by the FDA for clinical use. Capacitance circuitry, airflow sensors, and/or pressure transducers will be suspended within the upper aerodigestive tract along a thin, low-profile, and flexible tube. During Phase I of the study, this aerodynamic probe will be placed in the OR during DISE along the upper airway, namely in the retropalatal, retroglossal, and hypopharyngeal regions. Readings will be correlated and calibrated with DISE findings in real-time. During Phase II, these sensors will again be placed within the same patients during in-office sleep studies. The results from the sleep study will be analyzed in conjunction with OR findings in order to create an aerodynamic model for natural sleep. This will also allow the investigators to assess whether airway observations during DISE were valid representations of natural sleep.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moderate to severe obstructive sleep apnea who have failed a trial of CPAP.
Key inclusion criteria (9 listed)
- Patients with moderate to severe OSAS
- Must have symptoms of OSAS
- Must have sleep study showing AHI of 15 or greater
- Failed trial of CPAP
- BMI less than 35
Key exclusion criteria (16 listed)
- Prior ablative airway surgeries
- Allergies to oxymetazoline or lidocaine
- Significant central sleep apnea
- Presence of other sleep disorders
- History of neurologic or neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
site of airway obstruction
Time frame: 3 months
the presence or absence of airway obstruction in the retropalatal, retroglossal, and hypopharyngeal areas
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
Related trials for Obstructive Sleep Apnea
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.
Erica Thaler, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Dr. Erica Thaler 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 9 inclusion and 16 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 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
site of airway obstruction (time frame: 3 months). 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 30 Sep 2021.