Electromed has resumed a study seeking to assess the effects of SmartVest, an inflatable vest that can be used to deliver high-frequency chest wall oscillation (HFCWO) therapy, on the quality of life of patients with bronchiectasis.
The study (NCT04271969) was paused last year due to safety concerns posed by the COVID-19 pandemic. However, according to the company, the study has now been given a green light to resume at four sites across the U.S. More information about these sites and ongoing recruitment is available here.
“Our latest prospective bronchiectasis outcome study, which was placed on hold last year due to the pandemic, has resumed at four sites. Though patient enrollment, understandably, has been slower than normal given COVID-19 concerns,” Kathleen Skarvan, president and CEO of Electromed, said in a recent company webcast.
HFCWO is an airway clearance therapy based on the use of special inflatable vests that squeeze the abdomen and upper body to promote the release of mucus trapped inside the airways. This type of mechanical stimulation uses vibrations with varying degrees of intensity and frequency.
HFCWO is used frequently to help patients with certain lung disorders, such as bronchiectasis or cystic fibrosis, expel mucus and breathe more easily.
Compared with other vests, Elecromed’s SmartVest is quieter, lighter, and more comfortable as it is able to provide a higher degree of decompression when worn, according to the company.
SmartVest also can be paired with a mobile app, called SmartVest Connect, that can be found at App Store and Google Play. This tool, which was released last year, aims to provide patients with an easy way of managing their treatment and set personal reminders.
Data from a previous study showed that when used to deliver HFCWO, SmartVest reduced the number of disease flare-ups requiring hospitalization, lower antibiotic usage, and stabilize lung function in patients with bronchiectasis.
Electromed has now resumed a one-year study that aims to assess the impact of HFCWO delivered by its SmartVest device on the quality of life of around 100 adults diagnosed with bronchiectasis within six months of enrollment.
Quality of life will be assessed at enrollment, and at two months, six months and one year of treatment.
At each time point, quality of life will be assessed by the quality of life-bronchiectasis (QOL-B) questionnaire. The study’s main goal is to compare participants’ quality of life before and throughout one year of treatment.
Additional goals include assessing the effects of treatment on the number of disease flare-ups. Patients’ medical records will be used to extract information on the frequency of flare-ups.
The company is confident this study will demonstrate the value of SmartVest at improving patients’ quality of life.
“SmartVest improves quality of life. We are leveraging a growing number of patient, positive testimonials that come directly from them,” Skarvan said during the webcast. As an example, Skarvan read the testimonial of Diane, a patient who has been wearing SmartVest for several years.
“I wear it twice a day for 20 minutes each. It has been a godsend and totally turned my life around. I have said it saved my life as I constantly was in the hospital with lung infections. Now I still do the two treatments daily as ordered by my doctors, and haven’t been in the hospital for seven years,” she said.