NCT03324529

Autonomic Modulation in Takotsubo Syndrome

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a minimal risk case-controlled single arm intervention study, including 10 patients with a prior history of takotsubo and 10-age and sex matched healthy controls. Subjects will undergo in laboratory testing to measure autonomic function. They will then undergo a 15-week program of device-guided breathing with remote measures of autonomic function obtained at home. Analysis will determine the reproducibility of home autonomic measures and the provide preliminary data to determine the efficacy of device-guided breathing on autonomic measures and quality of life in patients with takotsubo.

Conditions

• Takotsubo Syndrome

Interventions

Type	Name	Description
DEVICE	Tako Breath	Device guided breathing. A medical device with a computerized control unit, a breathing sensor and a set of earphones with audio-prompts to guide breathing at a slow rate (\<10 breaths/min) with prolonged exhalation.

Timeline

• Start date: 2021-10-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2017-10-27
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study