The Multicentre Wavy Stress Study: Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA Caused by Vasospasms.

Rationale: The majority of women with angina and non-obstructive coronary arteries (INOCA) do have underlying epicardial or microvascular coronary vasospasms as revealed by invasive vasomotor testing. It is well known that stress is one of the important triggers of coronary vasospasms, therefore, stress reduction is of importance to this population. 'Wavy' is a smartphone application that estimates stress levels through a collection of physiological data by smartwatches and offers music guided relaxation through bio-feedback when these levels appear too high. It is hypothesized that the use of 'Wavy' will result in less stress and consequently fewer complaints of angina pectoris.

Objective: This study sets out to assess whether incorporating Wavy in daily life results in a better quality of life as measured through the primary outcome: visual analogue scale on pain (VAS) score and secondary outcomes: perceived stress score (PSS-10) quality of life (SF-36), heart rate variability (HRV) based stress levels, and angina frequency.

Study design: Patients will be enrolled in a single-arm placebo-controlled multicentre trial, consisting of 4 weeks placebo followed by 4 weeks intervention.

Study population: The study population will consist out of 250 women from 5 cardiology centres, aged between 18 and 70, who are diagnosed with INOCA with coronary vasomotor disorders.

Intervention: The smartphone application ''Wavy'' offers music guided relaxation when stress levels, as measured by biological parameters through the wearable, are too high.