Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA

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.

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.

Study Overview

• Status: Completed
• Conditions: Ischemia; Stress; Angina, Stable; Vasospasm, Coronary; Prinzmetal Angina; Vasomotor; Spasm
• Intervention / Treatment: Behavioral: Wavy stress application

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboud universty medical center
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229 HX
      • Maastricht UMC
    • Venlo, Limburg, Netherlands, 5900BX
      • VieCuri
  • Noord Brabant
    • Eindhoven, Noord Brabant, Netherlands, 5623 EJ
      • Catharina Hospital
    • Tilburg, Noord Brabant, Netherlands, 5042AD
      • Elisabeth-TweeSteden Hospital
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3079 DZ
      • Maasstad Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Female participants are recruited from the cardiology outpatient clinics at the department of cardiology Radboudumc, Maastricht UMC, Catharina Hospital Eindhoven, St. Elisabeth Hospital Tilburg, Maasstad Hospital and in VieCuri MC, Venlo. All participants have must meet

Inclusion criteria:

1. Female.
2. Aged 18-70 (upper-limit, because of increased comorbidities and potential difficulties with using the technology).
3. Suffering from chronic angina pectoris.
4. Diagnosed with INOCA, documented within 2 years, with a coronary angiogram and an abnormal coronary function test (CFT), indicative of either epicardial or microvascular vasospasms.
5. Daily usage of a smartphone with an operating system equal to or higher than Android 5.0 (Lollipop) or IOS 10.0.
6. Signed written informed consent.

Excluded criteria:

1. She is not available for the assigned research period of approximately 10 weeks from May 2021 till October 2022. The application can be used during the planned holidays.
2. She is unable to participate in the stress-reducing exercise, e.g., due to hearing problems.
3. A language barrier is present.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Control vs intervention; Each subject will take part in a four-week control period, followed by a four-week intervention period.

Behavioral: Wavy stress application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seattle angina questionnaire	A valid, reproducible, responsive instrument for assessing disease-specific health status among patients with coronary artery disease	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score on pain	Visual scale of 1-100 on pain	10 weeks
Heart rate variability	Semi semi-continuous 30 second heart rate variabillity (hrv) derived from photoplethysmogram (PPG) signal measurements each 15 minutes	10 weeks
Perceived stress score	PSS-10 questionnaire, validated questionnaire indicating perceived stress	10 weeks
SF-36	Quality of life questionnaire	10 weeks
Symptom diary	Descriptions and time labeling of experienced symptoms	10 weeks

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Maastricht University Medical Center; Catharina Ziekenhuis Eindhoven; ZonMw: The Netherlands Organisation for Health Research and Development; VieCuri Medical Centre; Maasstad Hospital; Health Holland; Netherlands Organisation for Scientific Research; The Elisabeth-TweeSteden Hospital
• Investigators: Principal Investigator: Suzette Elias-Smale, dr., Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Angina, Unstable; Ischemia; Angina Pectoris; Angina, Stable; Angina Pectoris, Variant; Coronary Vasospasm
• Other Study ID Numbers: .NL77493.091.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No