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

NCT ID: NCT02547688

Last Updated: 2017-08-08

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-01-31

Brief Summary

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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

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Conditions

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Healthy Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Nasal High Flow

All subjects are in this group

Group Type OTHER

Nasal High Flow

Intervention Type DEVICE

Interventions

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Nasal High Flow

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Kirkness, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00046727

Identifier Type: -

Identifier Source: org_study_id

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