Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA
Condition: Stress; Ischemia; Vasospasm, Coronary; Vasomotor; Spasm; Angina, Stable; Prinzmetal Angina
MeSH terms: Angina Pectoris; Angina, Stable; Coronary Vasospasm; Angina Pectoris, Variant; Ischemia
Study type: Interventional

Summary: 
      For women that experience angina symptoms with underlying vascular spasm as the cause, stress
      has an aggravating role. Coping with stress is therefore included as an important pillar in
      dealing with this chronic disease, see the European Association of Percutaneous
      Cardiovascular Interventions (EACPI) consensus document on INOCA. In practice, stress
      management focuses on informing and identifying the role stress plays in their lives. A
      potential stress management tool: "Wavy" aims to help users manage stress more consciously
      through biofeedback. This research focuses on the effectiveness of stress management
      applications. The hypothesis is that the app will help to avoid the trigger stress as much as
      possible and thus reduce the burden of disease.
    

Detailed description: 
      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.

      Main study parameters/endpoints: The primary study parameter is the difference between the
      VAS scores before and after the intervention period.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: To ensure a low burden for the participants, the trial will be executed
      digitally, meaning that, aside from delivering the wearables, all contact will be through
      online and phone contact. Over the course of approximately two months, the participant will
      be asked to watch an introduction video series, explaining the proper usage of Wavy
      Assistant, also they will be asked to wear a smartwatch, and to use a music guided relaxation
      for approximately 10 minutes at a time. In addition, the participants will be asked to fill
      out three questionnaires twice, taking approximately ninety minutes in total. Overall, the
      risk of the intervention is negligible. The potential benefit of the intervention is a
      reduction of symptoms of angina in patients through music guided relaxation, which is a
      natural, non-medical therapy without risk of side effects.
    

Intervention name(s): Wavy stress application
Intervention type(s): Behavioral
Intervention description(s): The intervention consists of the application named Wavy. Wavy uses artificial intelligence and the user's feedback to detect stress increasingly more efficient over time. This provides not only real-time feedback on an individual's stress level but also helps the patient to calm down using music guided relaxation. It does so with a music filter, allowing the participant to listen to music where the stress level determines the quality of the music.
Thus, relaxing is rewarded by improving the experience. In this process, implicit learning is used to establish a habit of getting better at recognising increased stress levels and getting familiar with reducing stress levels more and more effectively.
Intervention model: Single Group Assignment
Intervention model description: A single-arm, controlled, multicentre trial, will be conducted to validate to study objective. The study is divided into five iterative substudies of which the first four are aimed towards improving the application, based on the quantitative data from the smartwatch and the qualitative feedback of the users whilst also validating the recent version through assessing the interim study outcomes.
Masking: None (Open Label)
Primary purpose: Supportive Care