Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Sleep Apnea, Obstructive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Nasal Versus Oral Breathing on Measures of Drug-Induced Sleep Endoscopy
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.
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.
Primary outcome measures
- Classification of route of breathing and upper airway collapsibility during Drug-induced Sleep Endoscopy (DISE) [Time frame: Within 3 months of enrollment]
Secondary outcome measures (1)
- Percentage of Oral, Nasal, and Mixed Breathing during DISE and Polysomnography (PSG) [Time frame: Within 3 months of enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Hospital at the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06789770 · 857046