Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep

NCT ID: NCT06789770

Last Updated: 2025-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McCabe Fund

UNKNOWN

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julianna Rodin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Everett Seay

Role: CONTACT

215-662-2777

Rafa Khan

Role: CONTACT

Facility Contacts

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Rafa Khan

Role: primary

215-615-8777

Everett Seay

Role: backup

(215) 615-8777

Other Identifiers

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857046

Identifier Type: -

Identifier Source: org_study_id

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