Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
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
Verified date | May 2021 |
Source | Temple University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 15, 2019 |
Est. primary completion date | December 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | Temple University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Temple University | Fisher and Paykel Healthcare |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sputum Quantity | Volume of sputum | Measured daily for 90 days | |
Other | Sputum Consistency | Watery, thin, thick, none, no report made | Measured daily for 90 days | |
Other | Sputum Color | Clear, yellow, brown, white, none | Measured daily for 90 days | |
Other | Peak Flow | liters/minute | Measured daily for 90 days | |
Other | Body Temperature > 100 Degrees F | Yes/no Subjects recorded body temperature via thermometer | Measured daily for 90 days | |
Other | Presence of Cough | Yes/no | Measured daily for 90 days | |
Other | Presence of Wheeze | Yes/no | Measured daily for 90 days | |
Other | Presence of Sore Throat | Yes/no | Measured daily for 90 days | |
Other | Presence of Nasal Congestion | Yes/no | Measured daily for 90 days | |
Other | Polysomnography | Heart rate | 70 days | |
Other | Polysomnography | Pulse oximetry | 70 days | |
Other | Polysomnography | Total sleep time in hours | 70 days | |
Other | Polysomnography | Sleep efficiency (percent of time sleeping/total amount of time in bed) | 70 days | |
Primary | Use of Oxygen Therapy by HNHF-O2 at Home | Number of hours of use of the device per day as recorded on the device | 90 days | |
Secondary | Spirometry | Change in FEV1 | 90 days | |
Secondary | Change in 6 Minute Walk Distance | Total distance walked in 6 minutes | 90 days | |
Secondary | Breathlessness | Borg dyspnea scale Minimum value =0; Maximum value = 10 Higher scores mean greater shortness of breath | 90 days |
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