Clinical trial NCT03221387: Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients
Official title: Feasibility of Using Daily Home HNHF-O2 During Sleep and/or Daytime in Hypercapnic COPD Patients Following Recent (&lt 12 Wks.) Hospitalization for AECOPD for 90 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Hypercapnia
Hypoxia
Keywords: Therapy
Noninvasive Ventilation
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2017-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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).

Primary outcomes:
measure: Use of Oxygen Therapy by HNHF-O2 at Home
timeFrame: 90 days
Secondary outcomes:
measure: Spirometry
timeFrame: 90 days
measure: Change in 6 Minute Walk Distance
timeFrame: 90 days
measure: Breathlessness
timeFrame: 90 days
Other outcomes:
measure: Sputum Quantity
timeFrame: Measured daily for 90 days
measure: Sputum Consistency
timeFrame: Measured daily for 90 days
measure: Sputum Color
timeFrame: Measured daily for 90 days
measure: Peak Flow
timeFrame: Measured daily for 90 days
measure: Body Temperature > 100 Degrees F
timeFrame: Measured daily for 90 days
measure: Presence of Cough
timeFrame: Measured daily for 90 days
measure: Presence of Wheeze
timeFrame: Measured daily for 90 days
measure: Presence of Sore Throat
timeFrame: Measured daily for 90 days
measure: Presence of Nasal Congestion
timeFrame: Measured daily for 90 days
measure: Polysomnography
timeFrame: 70 days
measure: Polysomnography
timeFrame: 70 days
measure: Polysomnography
timeFrame: 70 days
measure: Polysomnography
timeFrame: 70 days
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University Lewis Katz School of Medicine
name: Gerard J Criner, MD
role: PRINCIPAL_INVESTIGATOR
References: