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StressNCT06171893

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

A study testing Wavy stress application in people with Stress and Ischemia, run by Radboud University Medical Center at 6 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Stress, Ischemia, Vasospasm, Coronary
What is being tested?
Wavy stress application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
6 sitesNetherlands
Study dates
1 Aug 2022to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female.
  • Aged 18-70 (upper-limit, because of increased comorbidities and potential difficulties with using the technology).
  • Suffering from chronic angina pectoris.
  • 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.
  • Daily usage of a smartphone with an operating system equal to or higher than Android 5.0 (Lollipop) or IOS 10.0.
  • Signed written informed consent.
Show all 10Show fewer
  • Excluded criteria:
  • 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.
  • She is unable to participate in the stress-reducing exercise, e.g., due to hearing problems.
  • A language barrier is present.

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Netherlands6 sites

  • Catharina Hospital

    Eindhoven, North Brabant, 5623 EJ

  • Maastricht UMC

    Maastricht, Limburg, 6229 HX

  • Radboud universty medical center

    Nijmegen, Gelderland, 6525GA

  • Maasstad Hospital

    Rotterdam, South Holland, 3079 DZ

  • Elisabeth-TweeSteden Hospital

    Tilburg, North Brabant, 5042AD

  • VieCuri

    Venlo, Limburg, 5900BX

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Wavy stress application
Medical subject headings
Ischemia, Coronary Vasospasm, Spasm, Angina, Stable, Angina Pectoris, Variant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wavy stress applicationBehavioural

    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.

Study groups in NCT06171893
Study groupRoleWhat they receive
Control vs interventionExperimentalEach subject will take part in a four-week control period, followed by a four-week intervention period.
Receives: Behavioral: Wavy stress application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. seattle angina questionnaire

    A valid, reproducible, responsive instrument for assessing disease-specific health status among patients with coronary artery disease

    Measured: 10 weeks

Secondary outcomes (5)

  1. VAS score on pain

    Visual scale of 1-100 on pain

    Measured: 10 weeks

  2. Heart rate variability

    Semi semi-continuous 30 second heart rate variabillity (hrv) derived from photoplethysmogram (PPG) signal measurements each 15 minutes

    Measured: 10 weeks

  3. Perceived stress score

    PSS-10 questionnaire, validated questionnaire indicating perceived stress

    Measured: 10 weeks

  4. SF-36

    Quality of life questionnaire

    Measured: 10 weeks

  5. Symptom diary

    Descriptions and time labeling of experienced symptoms

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start1 Aug 2022
  3. Primary completion23 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171893
Sponsor's protocol ID
.NL77493.091.21
Status last verified
Jan 2024
First submitted
28 Nov 2023
Last updated
19 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Faasse PD, de Vos A, Meeder JG, Van 't Hof AWJ, Winkler PJ, Widdershoven JWMG, Paradies V, Wouters E, Schouten G, Maas AHEM, Elias-Smale SE. Implementing a Smartphone and Wearable-Based Stress Management Intervention in Women With Coronary Artery Spasms to Reduce Cardiac Symptoms: Multicenter, Single-Arm, 1-Way Crossover Study. JMIR Form Res. 2026 Jul 28;10:e76146. doi: 10.2196/76146.

    PubMed 42517514

Questions about this trial

What is this clinical trial studying?

A study testing Wavy stress application in people with Stress and Ischemia, run by Radboud University Medical Center at 6 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

seattle angina questionnaire (time frame: 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06171893, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.

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