N/A
N=11
HHHFA in COPD Patients, With Chronic Bronchitis
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT03959982 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Sleep Quality Using the PSQI Questionnaire — -0.5; 1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HHHFA Device (Device); Spirometry (Diagnostic_test); 6-minute walk (Diagnostic_test); CT scan (Diagnostic_test); Medical Research Council dyspnea scale (MRC) (Other); St. George's Respiratory Questionnaire (SGRQ) (Other); COPD Assessment Test (CAT) (Other); Pittsburgh Sleep Quality Index (PSQI) (Other); CASA-Q (Other); Spirehealth Tag Device (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spyridon Fortis
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Quality Using the PSQI Questionnaire |
-0.5; 1 | — |
| SECONDARY 6 Minute Walk |
20; 1.5 | — |
| SECONDARY Health Related Quality of Life Change Using the CAT Questionnaire |
0; -7 | — |
Summary
Heated, humidified high-flow air (HHHFA) devices improve airway clearance. HHHFA use for an average of 1.6 hours a day in COPD patients with chronic bronchitis improves health-related quality of life, lung function, and delays the first respiratory exacerbation. However, HHHFA for an average of 1.6 hours a day had no effect on COPD exacerbation frequency or hospitalization, dyspnea, or exercise capacity, likely due to short duration of the treatment. Conversely, the effect of HHHFA for longer time periods on chronic bronchitis patients has not been studied. Moreover, the effect of HHHFA on sleep quality has not been studied. A prior study in COPD patients showed that use of HHHFA for more than 7 hours during sleep can be achieved. The overall objective of this research is to examine the effect of HHHFA during sleep on COPD patients with chronic bronchitis. In this pilot study, the study team will examine the effect of HHHFA during sleep on clinically relevant short-term outcomes including: respiratory symptoms, quality of life and sleep, lung function and exercise capacity.
Subjects will be recruited and consented. Once a subject agrees to be in the study the baseline visit will occur. The first test will be the Pulmonary Function testing. If the subject qualifies based on the PFT's they will complete the remainder of the baseline visit. During this visit subjects will complete questionnaires, have a physical, 6 minute walk test and CT scan. Subjects will receive device training on the heated, humidified high-flow air device.
Subjects will have a followup call between 3-7 days to check in on how the subject is doing with the device. After 6 weeks the subject will return for another round of testing as was done at baseline. This will be the final study visit.
Eligibility Criteria
Inclusion Criteria
- COPD diagnosis by health care provider
- Post-bronchodilator FEV1/FVC <0.7
- Post-bronchodilator FEV1%predicted <70%
- Chronic bronchitis, defined as chronic cough with daily sputum production
- ≥2 COPD exacerbations within the last year
- Smart phone
Exclusion Criteria
- Obstructive sleep apnea and using positive airway pressure treatment
- Patients that use oxygen supplementation continuously (patients that use oxygen supplementation only at exertion will NOT be excluded)
- Any planned procedure that the PI believes would cause the subject to be ineligible.
- Unable to perform a spirometry, 6-minute walk test or chest CT
- Recent diagnosis (<4 weeks prior to study entry) of pneumonia, respiratory infection, COPD exacerbation, or acute bronchitis requiring antibiotics and new/increased dose of systemic corticosteroids
- Thoracic surgery or another procedure in the last six months that may result in instability of pulmonary status
- Recent medical or surgical history of upper airway disease that may interfere with intervention (e.g., sinus surgery, significant nasal polyps)
- Recent chest illness (trauma, pneumothorax etc).
- Basal skull surgery in the last 6 months
- Open skin ulcer or rash where the nasal cannula will be worn
- Tracheostomy or laryngectomy
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03959982). 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.