Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:9/20/2018
Start Date:September 10, 2017
End Date:March 30, 2019
Contact:Michael Jacobs, PharmD
Email:MICHAEL.JACOBS@temple.edu
Phone:215-707-2242

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Feasibility of Using Daily Home HNHF-O2 During Sleep and/or Daytime in Hypercapnic COPD Patients Following Recent (< 12 Wks.) Hospitalization for AECOPD for 90 Days

Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute
beneficial effects in patients with hypoxemic respiratory failure who have been hospitalized.
The usefulness of this therapy in the outpatient setting is unproven. This pilot study will
test the feasibility of using this therapy in the outpatient setting and its effects on
sleep.

Humidified Nasal High-flow with Oxygen (HNHF-O2) therapy has been reported to have acute
beneficial effects in patients with hypoxemic respiratory failure. HNHF-O2 may be beneficial
in patients with COPD and chronic impairments in gas exchange, both hypoxemia as well as
hypercapnia. HNHF-O2 may decrease work of breathing, reduce dyspnea, improve airway
humidification, and potentially stabilize or reduce carbon dioxide levels. However, there is
limited data showing the chronic effects of HNHF-O2 in patients with hypercapnic respiratory
failure, specifically those discharged to home following hospitalization for an acute
exacerbation. Data that demonstrates that HNHF-O2 is well tolerated, and stabilizes or
improves gas exchange long term in patients with COPD is lacking. Similarly, data that
demonstrates that this therapeutic regimen is feasible to provide to patients in the home
environment are lacking. This is an open-labeled pilot study of thirty patients to determine
the safety and feasibility of using the device in the outpatient management of patients with
COPD. A subset of ten patients will have serial sleep studies to determine the effects, if
any, on sleep.

Inclusion Criteria:

- admitted to the hospital for an acute exacerbation of COPD within the past 12 weeks

- have COPD as the primary diagnosis

- have smoked > 10 pack years.

- receiving supplemental oxygen as part of their usual clinical care.

- willing to give informed consent

Exclusion Criteria:

- upper airway or nasal problems that prohibit the use of high flow oxygen

- current use (≤ 4 weeks of study entry) of any PAP-therapy (e.g., CPAP or NPPV)

- sleep apnea as follows: STOPBang scores ≥ 5 or STOPBang score ≥ 2 plus BMI > 35 kg/m2;
or Berlin questionnaire scores suggesting high likelihood of sleep apnea with
increased risk of sleep-related accident (e.g., occupation as a commercial driver or
pilot);

- excessive daytime sleepiness (i.e., either of High (>15) score on the Epworth
Sleepiness Scale or "fall asleep" accident or "near miss" accident in prior 12
months).
We found this trial at
1
site
3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Phone: 215-707-2242
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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mi
from
Philadelphia, PA
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