Diagnostic Validation of Drug-Induced Sleep Endoscopy (DISE)

NCT03391141 | Completed

• 1 other identifier: 827621
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; sleep endoscopy; drug induced sleep endoscopy; diagnostic validation

Outcome Measures

Primary Outcomes (1)

• site of airway obstruction

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

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with moderate to severe obstructive sleep apnea who have failed a trial of CPAP.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Erica Thaler: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Erica Thaler, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: January 5, 2018
• Study Start: April 9, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

US (1)