HHHFA in COPD Patients, With Chronic Bronchitis

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

HHHFA Device

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.

DIAGNOSTIC_TEST

Spirometry

Pre and post spirometry using albuterol.

DIAGNOSTIC_TEST

6-minute walk

6-minute walk

DIAGNOSTIC_TEST

CT scan

CT scan

OTHER

Medical Research Council dyspnea scale (MRC)

MRC questionnaire

OTHER

St. George's Respiratory Questionnaire (SGRQ)

SGRQ questionnaire

OTHER

COPD Assessment Test (CAT)

CAT questionnaire

OTHER

Pittsburgh Sleep Quality Index (PSQI)

PSQI questionnaire

OTHER

CASA-Q

CASA-Q questionnaire

OTHER

Spirehealth Tag Device

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

Sponsors & Collaborators

• American Thoracic Society

  collaborator OTHER

• Spyridon Fortis

  lead OTHER

Principal Investigators

• Spyridon Fortis, MD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-24

Primary Completion

2022-12-05

Completion

2022-12-05

FDA Device

Yes

Countries

• United States

Study Locations