Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06505109

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

Led by Erasmus Medical Center · Updated on 2026-03-13

200

Participants Needed

3

Research Sites

122 weeks

Total Duration

On this page

Sponsors

E

Erasmus Medical Center

Lead Sponsor

C

Capri Hartrevalidatie

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

OPTImizing CArdiac REhabilitation by REfining Sleep and STress

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participate in cardiac rehabilitation at one of the study centers for any cardiac diagnosis or reason as stated in the Dutch guidelines
  • Age 18 years or older
  • Proficient in the Dutch language
  • Experiencing sleep and/or stress problems indicated by a high score on the Pittsburgh Sleep Quality Index (PSQI >5) or Perceived Stress Scale-10 (PSS-10 >13)
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Severe psychiatric, cognitive, or physical conditions that prevent participation in cardiac rehabilitation
  • Currently receiving or expected to start treatment for sleep disorders, stress, or behavioral therapy during the first 6 months of the study that could interfere with the RESST intervention
  • Ongoing treatment resulting in unstable sleep or stress condition within 3 months before the cardiovascular event (except stable treatments like CPAP)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Máxima Medisch Centrum

Eindhoven, North Brabant, Netherlands, 5631BM

Actively Recruiting

2

Capri Hartrevalidatie

Rotterdam, South Holland, Netherlands, 3062MA

Actively Recruiting

3

Capri Hartrevalidatie

The Hague, South Holland, Netherlands, 2597AX

Actively Recruiting

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Research Team

N

Nienke ter Hoeve, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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OPTImizing CArdiac REhabilitation by REfining Sleep and STress | DecenTrialz