Assessment of the Tolerability of Dry Airflow in the Nasa... | NCT02547688

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

NCT02547688

Sponsor

Johns Hopkins University

Status

Withdrawn

Last Update Posted

Aug 8, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Healthy Adults

Interventions

Nasal High Flow

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study sponsor discontinued

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Sep 9, 2015

First Submission Date that Met QC Criteria

Sep 10, 2015

First Posted Date

Sep 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2017

Last Update Posted Date

Aug 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nasal High Flow	Other	All subjects are in this group	Device: Nasal High Flow

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasal High Flow	Device		Nasal High Flow

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Kirkness, PhD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21224	United States