Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep

Recruiting

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT06789770
• Lead Sponsor: University of Pennsylvania

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.

Study Timeline

• Study First Submitted: 2024-11-13
• Study Start: 2024-11-20
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-23
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Is someone a mouth or nose breather? What kind of airway obstruction and collapse do they have?	During the DISE (30 minutes)	Naming where the sites of obstruction are during DISE (by collecting a VOTE score) and noting whether the route of breathing is oral or nasal.

Secondary Outcome Measures

Name	Time	Method
Is a patients route of breathing the same during DISE and PSG?	During DISE (30 minutes) and PSG (1 night sleep study)	Compare route of breathing (oral, nasal or mixed) in DISE or in PSG.

Trial Locations

Locations (1)

Hospital at the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States