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Assessment of the Tolerability of Dry Airflow in the Nasal Cavity During Sleep

Not Applicable
Withdrawn
Conditions
Healthy Adults
Interventions
Device: Nasal High Flow
Registration Number
NCT02547688
Lead Sponsor
Johns Hopkins University
Brief Summary

Preliminary data show that high flow nasal air has been shown to reduce promote heat exchange due to evaporation of nasal mucus by the air flow resulting in heat loss. It is unclear whether unidirectional nasal airflow is well tolerated in healthy individuals. The central hypothesis of this proposal is that dry high flow nasal air will be sufficiently tolerated in healthy adults.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Healthy men and women
  • Able to consent
  • Age ≥ 18
  • BMI<30kg/m2
Exclusion Criteria
  • Previous diagnosis of obstructive sleep apnea or sleep disorder
  • History of Constant Positive Airway Pressure treatment for Obstructive Sleep Apnea
  • History of recurrent epistasis
  • Pregnancy (self-report)
  • Deviated nasal septum
  • Unstable cardiovascular disease (decompensated Congestive Heart Failure, myocardial infarction or revascularization procedures, unstable arrhythmias)
  • Uncontrolled hypertension with BP > 190/110
  • Daytime hypoxemia with oxygen saturation<90% (measured at history and physical examination)
  • Supplemental oxygen use
  • Work in transportation industry as a driver or pilot.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Nasal High FlowNasal High FlowAll subjects are in this group
Primary Outcome Measures
NameTimeMethod
Subjective Tolerability using QuestionnaireBaseline

Participant response to nasal high flow using 7 point Likert scale

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Johns Hopkins University

🇺🇸

Baltimore, Maryland, United States

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