N/A
N=30
Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients
Pulmonary Disease, Chronic Obstructive · Hypercapnia · Hypoxia
Bottom Line
View on ClinicalTrials.gov: NCT03221387 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Use of Oxygen Therapy by HNHF-O2 at Home — 6.8 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Humidified nasal high flow with oxygen (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Temple University
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use of Oxygen Therapy by HNHF-O2 at Home |
6.8 | — |
| SECONDARY Spirometry |
0.07 | — |
| SECONDARY Change in 6 Minute Walk Distance |
18.8 | — |
| SECONDARY Breathlessness |
4.25 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03221387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.