Cardiovascular DiseasesOPTICARE-RESSTNCT06505109
OPTImizing CArdiac REhabilitation by REfining Sleep and STress
A study testing RESST in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by Erasmus Medical Center at 3 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Rehabilitation
- What is being tested?
- RESST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesNetherlands
- Study dates
- 28 Aug 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Máxima Medisch Centrum
Eindhoven, North Brabant, 5631BM
Esmée Ooms, MSc, +31622366387, e.ooms@erasmusmc.nl
Inge van Loon, MSc, +31622366387, i.g.vanloon@erasmusmc.nl
- Recruiting
Capri Hartrevalidatie
Rotterdam, South Holland, 3062MA
Esmée Ooms, MSc, +31622366387, e.ooms@erasmusmc.nl
Inge van Loon, MSc, +31622366387, i.g.vanloon@erasmusmc.nl
- Recruiting
Capri Hartrevalidatie
The Hague, South Holland, 2597AX
Esmée Ooms, MSc, +31622366387, e.ooms@erasmusmc.nl
Inge van Loon, MSc, +31622366387, i.g.vanloon@erasmusmc.nl
About this study
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.
Read the detailed description
CR focuses on the secondary prevention of cardiovascular disease (CVD) by promoting a healthy lifestyle and is a valuable approach to improve quality of life, mortality and hospital readmissions. However, optimization of CR is necessary. Current CR programs pay insufficient attention to sleep and stress problems, despite more than 50% of CVD patients experiencing sleep problems and high stress levels. Both sleep and stress are associated with adverse cardiovascular health and a decreased quality of life. The hypothesis for this study is that adding a behavioural intervention will improve sleep and perceived stress (primary outcomes), along with positive outcomes on biomarkers of chronic stress, QoL, cardiometabolic risk factors, physical fitness, lifestyle components, and psychosocial well-being.
The project involves a multicenter randomized controlled trial. The intervention group (100 patients) will receive standard CR along with the RESST intervention, consisting of 5-6 on-site group sessions integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy and focused on improving sleep and stress. The control group (100 patients) will receive standard multidisciplinary CR only.
The primary outcomes of the study include both objective and subjective measures of sleep, as well as perceived stress. Secondary outcomes encompass quality of life, chronic stress biomarkers, cardiometabolic risk factors, physical fitness, lifestyle components and psychosocial wellbeing. These outcomes will be assessed before and after the intervention, as well as at a 6-month follow-up.
- Conditions
- Cardiovascular Diseases, Cardiac Rehabilitation
- Being tested
- RESST
- Keywords
- Cardiovascular Diseases, Cardiac Rehabilitation, Sleep, Stress
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESSTBehavioural
Subjects randomized to the RESST intervention will receive on top of standard rehabilitation a behavioural group intervention focussing on improving sleep and stress. This intervention will consist of 5 group sessions of 120 minutes each in the local rehabilitation centre. Sessions should be completed within a maximum of 4 months since the start of CR.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive standard CR along with the RESST intervention, consisting of 5 on-site group sessions, focused on sleep and stress, integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy. Receives: Behavioral: RESST |
| Control group | No intervention | The control group will receive standard CR only. Standard CR programs consist of 6-12 weeks of twice-weekly supervised, group-based exercise sessions. In addition, educational sessions are provided, covering topics such as medical information, cardiovascular risk factors, adopting a heart-healthy lifestyle, and coping with emotions. Depending on the patient's specific needs, counselling sessions on stress management, smoking cessation, and healthy diet are available, and individual counselling can be provided by a social worker, dietician, or psychologist/psychiatrist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively assessed sleep duration
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Measured: At baseline, after 3 months, and after 6 months.
Objectively assessed sleep-onset latency
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Measured: At baseline, after 3 months, and after 6 months.
Objectively assessed wake after sleep onset
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Measured: At baseline, after 3 months, and after 6 months.
Objectively assessed sleep efficiency
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Measured: At baseline, after 3 months, and after 6 months.
Self-reported sleep quality
This will be measured with the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Score between 0-21, higher score indicates worse sleep quality.
Measured: At baseline, after 3 months, and after 6 months.
Perceived stress level
This will be measured with the Perceived Stress Scale-10 (PSS-10) questionnaire. Score between 0-40, higher score indicates higher perceived stress.
Measured: At baseline, after 3 months, and after 6 months.
Secondary outcomes (44)
Cortisol level
This will be measured by taking a hair sample. The amount of cortisol in the hair will be determined in a lab.
Measured: At baseline, after 3 months, and after 6 months.
Cortisone level
This will be measured by taking a hair sample. The amount of cortisone in the hair will be determined in a lab.
Measured: At baseline, after 3 months, and after 6 months.
Weight
Weight will be measured with a digital scale in kilograms.
Measured: At baseline, after 3 months, and after 6 months.
Height
Height will be measured with a stadiometer in centimeters.
Measured: At baseline.
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Measured: At baseline, after 3 months, and after 6 months.
Blood pressure
Blood pressure will be measured with a blood pressure monitor.
Measured: At baseline, after 3 months, and after 6 months.
Smoking behaviour
This will be measured with a carbon monoxide breath tester.
Measured: At baseline, after 3 months, and after 6 months.
Smoking behaviour
This will be measured with a self-designed questionnaire. The outcome of this questionnaire indicates whether a person smokes/has smoked in the past/does not smoke, what sort of tobacco is being smoked and how much the participant smokes.
Measured: At baseline, after 3 months, and after 6 months.
Muscle strength
Handgrip strength will be measured with a hand dynamometer.
Measured: At baseline, after 3 months, and after 6 months.
Physical activity
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Measured: At baseline, after 3 months, and after 6 months.
Sedentary behaviour
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Measured: At baseline, after 3 months, and after 6 months.
Alcohol use
This will be measured with the five-shot questionnaire. Score between 0-7, higher score indicates higher chance of alcohol overuse, misuse, and dependency.
Measured: At baseline, after 3 months, and after 6 months.
Health related quality of life
This will be measured with the MacNew questionnaire. Score between 1-7, higher score indicates higher health related quality of life.
Measured: At baseline, after 3 months, and after 6 months.
Health related quality of life
This will be measured with the EuroQol 5D/EQ5D questionnaire. Score between -0.446 - 1, higher score indicates a better health state. One subscale has a score between 0-100, higher score indicates better perceived health.
Measured: At baseline, after 3 months, and after 6 months.
Fatigue
This will be measured with the Fatigue Severity Scale (FSS) questionnaire. Score between 9-63, higher score indicates a greater fatigue severity.
Measured: At baseline, after 3 months, and after 6 months.
Daytime sleepiness
This will be measured with the Epworth Sleepiness Scale (ESS) questionnaire. Score between 0-24, higher score indicates a higher level of daytime sleepiness.
Measured: At baseline, after 3 months, and after 6 months.
Anxiety and depression
This will be measured with the Hospital Anxiety and Depression Scale (HADS) questionnaire. Score between 0-21 per subscale, higher score indicates severe symptoms of anxiety and depression.
Measured: At baseline, after 3 months, and after 6 months.
Participation in society
This will be measured with the USER-Participatie (USER-P) questionnare. Score between 0-100, higher score indicates higher participation in society.
Measured: At baseline, after 3 months, and after 6 months.
Estimated Cardiorespiratory fitness
This will be measured with the FitMáx©-Questionnaire. The outcome of this questionnaire is the estimated maximum oxygen uptake expressed in mL/kg/min. Higher score indicates better cardiorespiratory fitness.
Measured: At baseline, after 3 months, and after 6 months.
Presence of restless leg syndrome
This will be measured with the RLS rating scale questionnaire. Score between 0-28, higher score indicates more severe symptoms of restless leg syndrome.
Measured: At baseline.
Presence of insomnia
This will be measured with the Insomnia Severity Index (ISI) questionnaire. Score between 0-28, higher score indicates more severe insomnia complaints.
Measured: At baseline.
The risk of the presence of obstructive sleep apnoea
This will be measured with the STOP-bang questionnaire. Score between 0-8, higher score indicates higher risk of obstructive sleep apnoea.
Measured: At baseline.
Costs incurred by the patients
This will be measured with the IMTA Medical Consumption Questionnaire (IMCQ) which aims to determine costs within the health care system.
Measured: After 3 months and after 6 months.
Productivity costs
This will be measured with the IMTA Productivity Costs Questionnaire (IPCQ) which aims to determine the cost of productivity losses.
Measured: After 3 months and after 6 months.
Perceived sleep
This will be measured with the Sleep Consensus Diary for 7 days. The Sleep Consensus Diary consists of questions about the experience of sleep, what time the participant went to sleep, and how often the participant woke up.
Measured: At baseline, after 3 months, and after 6 months.
Diet
This will be measured with an electronic diary. Intake of caffeine and alcohol and timing of the main meal will be measured.
Measured: At baseline, after 3 months, and after 6 months.
Momentary fatigue
This will be measured with an electronic diary.
Measured: At baseline, after 3 months, and after 6 months.
Momentary stress
This will be measured with an electronic diary.
Measured: At baseline, after 3 months, and after 6 months.
Adherence to the CR treatment and RESST intervention
This will be measured by recording the number of rehabilitation components attended, such as courses on nutrition or personal counseling.
Measured: After 3 months.
Treatment Satisfaction
This will be measured with a self-designed questionnaire and consists of questions about the applicability, clarity and logistics of the intervention.
Measured: After 3 months.
Sex
Female / male / other
Measured: At baseline.
Age
Age in years.
Measured: At baseline.
Cardiac diagnosis
Cardiac diagnosis as defined by ICD-10 that has resulted in referral to cardiac rehabilitation.
Measured: At baseline.
Educational level
Single-item question (high, middle, or low educated).
Measured: At baseline.
Relational status
Single-item question.
Measured: At baseline.
Cardiac risk factors
Presence of cardiac risk factors (family history, diabetes mellitus, hypertension, dyslipidemia, smoking prior to event).
Measured: At baseline.
Cardiac history
History of cardiovascular events and diseases.
Measured: At baseline.
Medication usage
Number of participants using a certain type of prescribed and/or over-the-counter medication.
Measured: At baseline, after 3 months, and after 6 months.
Comorbidity
Presence of other diseases.
Measured: At baseline.
Socioeconomic status
Socioeconomic status indicated by postal code.
Measured: At baseline.
Origin
Determined by birth country and parents' birth country.
Measured: At baseline.
Employment
Determined by employment status, and type of job.
Measured: At baseline.
Drug use
Drug use (yes/no) and drug classification.
Measured: At baseline.
Current/previous sleep disorder treatment
Description of current and previous treatment for sleeping disorders.
Measured: At baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start28 Aug 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomized to treatment or control.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Capri Hartrevalidatie, Maxima Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, N. (Nienke) ter Hoeve PhD, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505109
- Sponsor's protocol ID
- NL86677.078.24
- Other IDs
- 10930012310027
- Acronym
- OPTICARE-RESST
- Status last verified
- Mar 2026
- First submitted
- 1 Jul 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
van Loon I, Ooms E, Luik A, Sunamura M, Wally T, Boersma E, Vromen T, Tenbult-van Limpt N, Bussmann H, Boon M, Louter M, Redekop K, Ista E, van den Berg-Emons R, Ter Hoeve N; other OPTICARE-RESST Consortium members. Optimising sleep and managing stress by integrating a behavioural intervention during cardiac rehabilitation: rationale and design of the OPTICARE-RESST multicentre randomised controlled trial. BMJ Open. 2026 Apr 16;16(4):e117963. doi: 10.1136/bmjopen-2026-117963.
PubMed 41991268
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImizing CArdiac REhabilitation by REfining Sleep and STress
- ClinicalTrials.gov ID
- NCT06505109
- Acronym / sponsor ID
- OPTICARE-RESST / NL86677.078.24
- Conditions
- Cardiovascular Diseases, Cardiac Rehabilitation
- Keywords
- Cardiovascular Diseases, Cardiac Rehabilitation, Sleep, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Capri Hartrevalidatie, Maxima Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CR focuses on the secondary prevention of cardiovascular disease (CVD) by promoting a healthy lifestyle and is a valuable approach to improve quality of life, mortality and hospital readmissions. However, optimization of CR is necessary. Current CR programs pay insufficient attention to sleep and stress problems, despite more than 50% of CVD patients experiencing sleep problems and high stress levels. Both sleep and stress are associated with adverse cardiovascular health and a decreased quality of life. The hypothesis for this study is that adding a behavioural intervention will improve sleep and perceived stress (primary outcomes), along with positive outcomes on biomarkers of chronic stress, QoL, cardiometabolic risk factors, physical fitness, lifestyle components, and psychosocial well-being.
The project involves a multicenter randomized controlled trial. The intervention group (100 patients) will receive standard CR along with the RESST intervention, consisting of 5-6 on-site group sessions integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy and focused on improving sleep and stress. The control group (100 patients) will receive standard multidisciplinary CR only.
The primary outcomes of the study include both objective and subjective measures of sleep, as well as perceived stress. Secondary outcomes encompass quality of life, chronic stress biomarkers, cardiometabolic risk factors, physical fitness, lifestyle components and psychosocial wellbeing. These outcomes will be assessed before and after the intervention, as well as at a 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized to treatment or control.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: RESSTThe intervention group will receive standard CR along with the RESST intervention, consisting of 5 on-site group sessions, focused on sleep and stress, integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy. |
| Control group | No intervention | –The control group will receive standard CR only. Standard CR programs consist of 6-12 weeks of twice-weekly supervised, group-based exercise sessions. In addition, educational sessions are provided, covering topics such as medical information, cardiovascular risk factors, adopting a heart-healthy lifestyle, and coping with emotions. Depending on the patient's specific needs, counselling sessions on stress management, smoking cessation, and healthy diet are available, and individual counselling can be provided by a social worker, dietician, or psychologist/psychiatrist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESSTSubjects randomized to the RESST intervention will receive on top of standard rehabilitation a behavioural group intervention focussing on improving sleep and stress. This intervention will consist of 5 group sessions of 120 minutes each in the local rehabilitation centre. Sessions should be completed within a maximum of 4 months since the start of CR. | Behavioural | Intervention group |
Primary outcome
Objectively assessed sleep duration
Time frame: At baseline, after 3 months, and after 6 months.
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Objectively assessed sleep-onset latency
Time frame: At baseline, after 3 months, and after 6 months.
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Objectively assessed wake after sleep onset
Time frame: At baseline, after 3 months, and after 6 months.
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Objectively assessed sleep efficiency
Time frame: At baseline, after 3 months, and after 6 months.
This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Self-reported sleep quality
Time frame: At baseline, after 3 months, and after 6 months.
This will be measured with the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Score between 0-21, higher score indicates worse sleep quality.
Perceived stress level
Time frame: At baseline, after 3 months, and after 6 months.
This will be measured with the Perceived Stress Scale-10 (PSS-10) questionnaire. Score between 0-40, higher score indicates higher perceived stress.
44 secondary outcomes
Cortisol level
Time frame: At baseline, after 3 months, and after 6 months.
Cortisone level
Time frame: At baseline, after 3 months, and after 6 months.
Weight
Time frame: At baseline, after 3 months, and after 6 months.
Height
Time frame: At baseline.
Body Mass Index (BMI)
Time frame: At baseline, after 3 months, and after 6 months.
Blood pressure
Time frame: At baseline, after 3 months, and after 6 months.
Smoking behaviour
Time frame: At baseline, after 3 months, and after 6 months.
Smoking behaviour
Time frame: At baseline, after 3 months, and after 6 months.
Muscle strength
Time frame: At baseline, after 3 months, and after 6 months.
Physical activity
Time frame: At baseline, after 3 months, and after 6 months.
Sedentary behaviour
Time frame: At baseline, after 3 months, and after 6 months.
Alcohol use
Time frame: At baseline, after 3 months, and after 6 months.
Health related quality of life
Time frame: At baseline, after 3 months, and after 6 months.
Health related quality of life
Time frame: At baseline, after 3 months, and after 6 months.
Fatigue
Time frame: At baseline, after 3 months, and after 6 months.
Daytime sleepiness
Time frame: At baseline, after 3 months, and after 6 months.
Anxiety and depression
Time frame: At baseline, after 3 months, and after 6 months.
Participation in society
Time frame: At baseline, after 3 months, and after 6 months.
Estimated Cardiorespiratory fitness
Time frame: At baseline, after 3 months, and after 6 months.
Presence of restless leg syndrome
Time frame: At baseline.
Presence of insomnia
Time frame: At baseline.
The risk of the presence of obstructive sleep apnoea
Time frame: At baseline.
Costs incurred by the patients
Time frame: After 3 months and after 6 months.
Productivity costs
Time frame: After 3 months and after 6 months.
Perceived sleep
Time frame: At baseline, after 3 months, and after 6 months.
Diet
Time frame: At baseline, after 3 months, and after 6 months.
Momentary fatigue
Time frame: At baseline, after 3 months, and after 6 months.
Momentary stress
Time frame: At baseline, after 3 months, and after 6 months.
Adherence to the CR treatment and RESST intervention
Time frame: After 3 months.
Treatment Satisfaction
Time frame: After 3 months.
Sex
Time frame: At baseline.
Age
Time frame: At baseline.
Cardiac diagnosis
Time frame: At baseline.
Educational level
Time frame: At baseline.
Relational status
Time frame: At baseline.
Cardiac risk factors
Time frame: At baseline.
Cardiac history
Time frame: At baseline.
Medication usage
Time frame: At baseline, after 3 months, and after 6 months.
Comorbidity
Time frame: At baseline.
Socioeconomic status
Time frame: At baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Derived from this study: PubMed 41991268van Loon I, Ooms E, Luik A, Sunamura M, Wally T, Boersma E, Vromen T, Tenbult-van Limpt N, Bussmann H, Boon M, Louter M, Redekop K, Ista E, van den Berg-Emons R, Ter Hoeve N; other OPTICARE-RESST Consortium members. Optimising sleep and managing stress by integrating a behavioural intervention during cardiac rehabilitation: rationale and design of the OPTICARE-RESST multicentre randomised controlled trial. BMJ Open. 2026 Apr 16;16(4):e117963. doi: 10.1136/bmjopen-2026-117963.
- Individual participant dataSharing planned: Yes
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESST in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by Erasmus Medical Center at 3 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nienke ter Hoeve, PhD (+31107033190, n.terhoeve@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively assessed sleep duration (time frame: At baseline, after 3 months, and after 6 months.). The study lists 6 primary outcomes in all. 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 NCT06505109, 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 13 Mar 2026.