NCT02547688

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

3 years

First QC Date

September 9, 2015

Last Update Submit

August 7, 2017

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • Subjective Tolerability using Questionnaire

    Participant response to nasal high flow using 7 point Likert scale

    Baseline

Study Arms (1)

Nasal High Flow

OTHER

All subjects are in this group

Device: Nasal High Flow

Interventions

Nasal High FlowDEVICE
Nasal High Flow

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women
  • Able to consent
  • Age ≥ 18
  • BMI\<30kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Study Officials

  • Jason Kirkness, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 11, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations

US(1)