Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep
ConditionSleep Apnea, Obstructive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
This project will provide important new information regarding (1) the relationship between route of breathing and airway collapsibility and (2) whether route of breathing during DISE (Drug-Induced Sleep Endoscopy) is representative of natural sleep.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Adults (≥ 18yrs) that underwent clinical evaluation at the CPAP Alternatives Clinic at Penn Otorhinolaryngology.
Must have at least mild OSA (AHI>5)
Disqualifiers
• Sleep study with an AHI<5, >25% of total events being central or mixed events, or inability to achieve adequate drug-induced sleep.
Upper Respiratory Illness at the time of the DISE.
Trial population
People who are referred to the PI's CPAP alternatives clinic. They are of all ages (18+) and all genders.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Classification of route of breathing and upper airway collapsibility during Drug-induced Sleep Endoscopy (DISE)
Participants will be classified as oral breathers if more than 50% of their total breaths during DISE occur through the oral route; otherwise, they will be classified as nasal breathers. The pattern of upper airway collapse will be characterized using the VOTE classification system, a standardized DISE scoring tool assessing the Velum (V), Oropharynx (O), Tongue Base (T), and Epiglottis (E). Each anatomical site is graded on a 0-2 scale, where 0 = no obstruction, 1 = partial obstruction, and 2 = complete obstruction. This outcome assesses relationships between breathing route classification and the anatomical pattern and severity of upper airway collapse
Time frame
Within 3 months of enrollmentSecondary outcomes
1
Percentage of Oral, Nasal, and Mixed Breathing during DISE and Polysomnography (PSG)
For each participant, every breath within the analysis window will be classified as oral, nasal, or mixed-approximately 5 minutes of stable breathing during DISE and ≥4 hours during overnight polysomnography (PSG). The primary output will be the percentage of breaths in each category for both modalities. Agreement between DISE-based and PSG-based breathing-route classification will be evaluated using statistical agreement methods (e.g., Bland-Altman analyses, concordance metrics).
Time frame
Within 3 months of enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
McCabe Fund
Collaborator
Source ClinicalTrials.gov