NCT06505109 OPTImizing CArdiac REhabilitation by REfining Sleep and STress
| NCT ID | NCT06505109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-08-28 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-08-28 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this project is to investigate the effectiveness and costs of integrating a behavioural program targeting sleep and stress (the RESST intervention) into cardiac rehabilitation (CR). In addition, the investigators will also study whether parameters regarding diversity (e.g., sex, ethnicity, socioeconomic position) are associated with intervention effectiveness. Furthermore, the investigators aim to explore the (bidirectional) relation between sleep and stress on the one hand, and other lifestyle components and health outcomes on the other hand.
Eligibility Criteria
Inclusion Criteria: * Participate in CR at one of the study centres for any cardiac diagnosis or reason as stated in the Dutch guidelines * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06505109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06505109 currently recruiting?
Yes, NCT06505109 is actively recruiting participants. Contact the research team at n.terhoeve@erasmusmc.nl for enrollment information.
Where is the NCT06505109 trial being conducted?
This trial is being conducted at Eindhoven, Netherlands, Rotterdam, Netherlands, The Hague, Netherlands.
Who is sponsoring the NCT06505109 clinical trial?
NCT06505109 is sponsored by Erasmus Medical Center. The trial plans to enroll 200 participants.