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

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02547688
• Other study ID #: IRB00046727
• Status: Withdrawn
• Phase: N/A
• First received: September 9, 2015
• Last updated: August 7, 2017
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Device:
• Nasal High Flow

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Tolerability using Questionnaire	Participant response to nasal high flow using 7 point Likert scale	Baseline