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NCT Number: NCT06789770

Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Classification of route of breathing and upper airway collapsibility during Drug-induced Sleep Endoscopy (DISE)

    Time frame: 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 outcomes

  1. Percentage of Oral, Nasal, and Mixed Breathing during DISE and Polysomnography (PSG)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Everett Seay

CONTACT

[email protected]

215-662-2777

Michael Nichols

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • McCabe Fund

Registry information

Official study title

The Impact of Nasal Versus Oral Breathing on Measures of Drug-Induced Sleep Endoscopy

Acronym: Nasal vs Oral

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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