Sleep Apnea, Obstructive
Conditions
Keywords
breathing route, OSA, nasal breathing, oral breathing
Brief summary
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.
Detailed description
As part of standard of care, a drug-induced sleep endoscopy will be done, where route of breathing will be determined as a percentage of total breaths (during baseline, lateral sleep and maneuver). As part of the research procedure, an in-laboratory Polysomnogram will be conducted as study procedure including a oronasal pressure signal cannula to assess route of breathing.
Interventions
None listed
Sponsors
University of Pennsylvania
McCabe Fund
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Adults (≥ 18yrs) that underwent clinical evaluation at the CPAP Alternatives Clinic at Penn Otorhinolaryngology. * Must have at least mild OSA (AHI\>5)
Exclusion criteria
* • 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classification of route of breathing and upper airway collapsibility during Drug-induced Sleep Endoscopy (DISE) | Within 3 months of enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Oral, Nasal, and Mixed Breathing during DISE and Polysomnography (PSG) | Within 3 months of enrollment | 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). |
Countries
United States
Contacts
CONTACTEverett Seay
CONTACTMichael Nichols
PRINCIPAL_INVESTIGATORJulianna Rodin, MD
University of Pennsylvania
Outcome results
None listed