Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep

University of Pennsylvania50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sleep Apnea, Obstructive

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

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 enrollment

Secondary Outcomes

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 enrollment

Central Contacts

Everett Seay

CONTACT

215-662-2777 seaye@pennmedicine.upenn.edu

Michael Nichols

CONTACT

nicholsm@pennmedicine.upenn.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.