CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
HHHFA Device +9 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03959982
NCT03959982N/ACompleted

The Effect of Heated, Humidified High-flow Air in COPD Patients With Chronic Bronchitis

Spyridon Fortis·interventional·Posted May 22, 2019·Updated Sep 19, 2024

In Brief

A clinical study evaluating HHHFA Device, Spirometry, and 8 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 22, 2019
Enrollment StartFeb 24, 2021
Primary CompletionDec 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.1 years ago

Interventions

HHHFA Devicedevice

Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.

Spirometryother

Pre and post spirometry using albuterol.

6-minute walkother

6-minute walk

CT scanother

CT scan

Medical Research Council dyspnea scale (MRC)other

MRC questionnaire

St. George's Respiratory Questionnaire (SGRQ)other

SGRQ questionnaire

COPD Assessment Test (CAT)other

CAT questionnaire

Pittsburgh Sleep Quality Index (PSQI)other

PSQI questionnaire

CASA-Qother

CASA-Q questionnaire

Spirehealth Tag Deviceother

Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.