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

August 7, 2017 updated by: Johns Hopkins University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Nasal High Flow
All subjects are in this group
Device: Nasal High Flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Tolerability using Questionnaire
Time Frame: Baseline
Participant response to nasal high flow using 7 point Likert scale
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Jason Kirkness, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00046727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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