Status:
COMPLETED
Diagnostic Validation of Drug-Induced Sleep Endoscopy (DISE)
Lead Sponsor:
Dr. Erica Thaler
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
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. Sensor...
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03391141
Start Date
April 9 2018
End Date
September 1 2021
Last Update
September 30 2021
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104