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

Johns Hopkins University

Status: Withdrawn

Conditions: Healthy Adults

Treatments: Device: Nasal High Flow

Study type: Interventional

Funder types: Other

Identifiers

NCT02547688

IRB00046727

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Nasal High Flow

Other group

Description:

All subjects are in this group

Treatment:

Device: Nasal High Flow