Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep

NCT06789770 | Recruiting

• 1 other identifier: 857046
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

breathing route; OSA; nasal breathing; oral breathing

Outcome Measures

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

  Within 3 months of enrollment

Secondary Outcomes (1)

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

  Within 3 months of enrollment

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

People who are referred to the PI's CPAP alternatives clinic. They are of all ages (18+) and all genders.

You may qualify if:

• Adults (≥ 18yrs) that underwent clinical evaluation at the CPAP Alternatives Clinic at Penn Otorhinolaryngology.
• Must have at least mild OSA (AHI\>5)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• McCabe Fund: collaborator

Study Sites (1)

Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

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

• Julianna Rodin, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Everett Seay

CONTACT

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

Michael Nichols

CONTACT

nicholsm@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: January 23, 2025
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)