Diagnostic Validation of Drug-Induced Sleep Endoscopy (DISE)

ID: NCT03391141
Status: Not yet recruiting
Phase: N/A
Start Date: March 12, 2018
First Submitted: December 08, 2017
Last Updated: February 14, 2018
Results: N/A
Sponsors & Collaborators: Dr. Erica Thaler
Location: N/A
Conditions: Obstructive Sleep Apnea
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Study Description

Brief 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. 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.
Condition or disease Intervention/treatment Phase

Obstructive Sleep Apnea

N/A

Tracking Information

First Submitted DateDecember 08, 2017
Last Update Posted DateFebruary 14, 2018
Anticipated Start DateMarch 12, 2018
Anticipated Completion DateJanuary 01, 2019
Anticipated Primary Completion DateJanuary 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • site of airway obstruction [Time Frame: 3 months]

    the presence or absence of airway obstruction in the retropalatal, retroglossal, and hypopharyngeal areas

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleDiagnostic Validation of Drug-Induced Sleep Endoscopy (DISE)
Official TitleIn Vivo Aerodynamic Modeling of the Upper Airway in OSA
Brief 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. 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 TypeObservational
Study PhaseN/A
Estimated Enrollment
16
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Obstructive Sleep Apnea
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationAdult patients with moderate to severe obstructive sleep apnea who have failed a trial of CPAP.
Intervention
Not Available
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment16
Completion DateJanuary 01, 2019
Eligibility Criteria: Inclusion Criteria:
- 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
- Acceptable surgical comorbidities
- Non-aberrant upper airway anatomy
- Must demonstrate reliability in keep appointments

Exclusion Criteria:
- 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
- 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT03391141
Other Study ID Numbers
827621
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyDr. Erica Thaler, University of Pennsylvania
Study Sponsor
Dr. Erica Thaler
Collaborators
Not Available
Investigators
Not Available