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Search / Trial NCT06505109

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

Launched by ERASMUS MEDICAL CENTER · Jul 10, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Cardiovascular Diseases Cardiac Rehabilitation Sleep Stress

ClinConnect Summary

This clinical trial, called the "OPTImizing CArdiac REhabilitation by REfining Sleep and STress" study, is looking at how a special program focused on improving sleep and reducing stress can help people with heart problems during their cardiac rehabilitation. The program, known as the RESST intervention, aims to see if it can make recovery more effective and whether different groups of people—based on factors like gender or socioeconomic status—respond differently to this program. The researchers are also interested in how sleep and stress affect other aspects of health and lifestyle.

To participate in this trial, you need to be at least 18 years old, speak Dutch, and have some difficulties with sleep or stress, as shown by specific scores on two questionnaires. If you have significant mental health issues or are currently receiving treatment for sleep or stress problems, you may not be eligible. If you decide to join, you can expect to take part in the RESST program alongside your regular cardiac rehabilitation. This study is currently recruiting participants, so it’s a great opportunity to contribute to important research that could help improve heart health for many people.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age at or above 18 years
  • Proficient in the Dutch language
  • Experiencing sleep and/or stress problems as indicated by a high score on the Pittsburgh Sleep Quality Index (PSQI score \>5) or Perceived Stress Scale-10 (PSS-10 score \>13)
  • Signed informed consent
  • Exclusion Criteria:
  • Severe psychiatric, cognitive or physical comorbidity that would impede CR participation
  • Active treatment for sleep disorders, stress, or other forms of (behavioural) therapy at the start of the study or expected to start within the first 6 months of the study, that could interfere with the RESST intervention. Note: Participants with previously diagnosed sleep disorders are eligible if they still experience sleep or stress problems, unless they fall under the above criteria. Participants who received a prior treatment that is still ongoing but has resulted in a stable sleep and stress condition in the 3 months before the cardiovascular event (e.g., Continuous Positive Airway Pressure (CPAP)) are eligible.

About Erasmus Medical Center

Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.

Locations

Eindhoven, North Brabant, Netherlands

Rotterdam, South Holland, Netherlands

The Hague, South Holland, Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported