The Effect of Heated, Humidified High-flow Air in COPD Patients With Chronic Bronchitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Sleep Quality Using the PSQI Questionnaire
Study Overview
Brief 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.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is characterized by respiratory exacerbations which increase in frequency as the severity of the disease progresses. COPD exacerbations may lead to hospitalizations, which make up the largest proportion of the total direct health-care cost of the disease and are a significant burden for patients and family. Chronic bronchitis, defined as chronic cough with sputum production for at least 3 months a year for 2 consecutive years, is one of the clinical manifestations of COPD. Chronic bronchitis doubles the risk of COPD exacerbations and hospitalizations, and is associated with increased dyspnea, worse health-related quality of life, and poorer quality of sleep. Chronic bronchitis also results in increased air trapping and hyperinflation, which decreases exercise capacity. Unfortunately, other than traditional inhaled pharmacological agents, there are no treatment options for COPD patients with chronic bronchitis.
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.
Hypothesis 1: HHHFA during sleep in COPD patients with chronic bronchitis improves respiratory symptoms, sleep quality, lung function, and exercise capacity.
Aim 1: To examine the effect of HHHFA during sleep on respiratory symptoms, sleep quality, lung function, and exercise capacity in COPD patients with chronic bronchitis.
The effect of HHHFA on air trapping and hyperinflation has not been studied. Air trapping and hyperinflation as well as other radiographic measurements associated with chronic bronchitis (e.g. airway wall thickness) can be measured using chest CT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: HHHFA Device (Device)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: Spirometry (Diagnostic Test)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: 6-minute walk (Diagnostic Test)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: CT scan (Diagnostic Test)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: Medical Research Council dyspnea scale (MRC) (Other)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: St. George's Respiratory Questionnaire (SGRQ) (Other)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: COPD Assessment Test (CAT) (Other)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: Pittsburgh Sleep Quality Index (PSQI) (Other)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: CASA-Q (Other)
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: Spirehealth Tag Device (Other)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: Spirometry (Diagnostic Test)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: 6-minute walk (Diagnostic Test)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: CT scan (Diagnostic Test)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: Medical Research Council dyspnea scale (MRC) (Other)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: St. George's Respiratory Questionnaire (SGRQ) (Other)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: COPD Assessment Test (CAT) (Other)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: Pittsburgh Sleep Quality Index (PSQI) (Other)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: CASA-Q (Other)
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Intervention: Spirehealth Tag Device (Other)
Outcomes
Primary Outcomes
Sleep Quality Using the PSQI Questionnaire
Time Frame: Baseline and 6 weeks
Pittsburgh Sleep Quality Index (PSQI) Questionnaires will be done at baseline and completion of study. This questionnaire will be used to collect information regarding the subject's usual sleep habits during the past month. PSQI: Pittsburgh Sleep Quality Index ranges from 0 to 21 with highest scores indicating worse sleep quality. Values presented here indicate the change between baseline and 6 weeks. Positive values indicate worse sleep quality at 6 weeks.
Secondary Outcomes
- 6 Minute Walk(Baseline and 6 weeks)
- Health Related Quality of Life Change Using the CAT Questionnaire(Baseline and 6 weeks)
Investigators
Spyridon Fortis
Pricipal Investigator
University of Iowa