Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06171893 |
| Other study ID # |
.NL77493.091.21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2024 |
| Source |
Radboud University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
