Cardiovascular Disease and Sleep HygieneSLEEP-CARDNCT07135921
Sleep Hygiene Education in Individuals With Cardiovascular Disease: Effects on Sleep Quality and Disease Management
A study testing Sleep Hygiene Education in people with Cardiovascular Disease and Sleep Hygiene, run by Near East University, Turkey.
Trial summary
This clinical trial aims to find out if sleep hygiene education helps people with cardiovascular disease manage their illness better and improve their sleep quality. Participants will be randomly assigned to two groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease and Sleep Hygiene
- What is being tested?
- Sleep Hygiene Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2025to 30 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 years or older
- Clinical diagnosis of cardiovascular disease at least one year prior
- No visual, hearing, communication, cognitive, or physical impairments
- Literate and able to use a smartphone and/or computer
- Willing to participate in the sleep hygiene education program
- Able to provide informed consent
Who cannot join
- Pregnancy
- Working night shifts
- Cognitive impairment preventing questionnaire completion
- Visual, hearing, communication, or physical impairments that prevent participation
About this study
Official title: The Effect of Sleep Hygiene Education on Disease Management and Sleep Quality in Individuals With Cardiovascular Diseases: A Randomized Controlled Clinical Trial Protocol
This clinical trial aims to find out if sleep hygiene education helps people with cardiovascular disease manage their illness better and improve their sleep quality.
Participants will be randomly assigned to two groups. One group will receive sleep hygiene education through a 30-minute presentation and twice-daily reminder messages for four weeks. The other group will receive usual care without education.
Read more
Before and after the four-week period, all participants will complete questionnaires about their sleep habits, sleep quality, and disease management.
The study hopes to show that sleep hygiene education can improve participants' sleep and help them manage their disease symptoms better, leading to a better quality of life.
The trial will take place at Near East University Hospital's Cardiology Department from June to December 2025.
- Conditions
- Cardiovascular Disease and Sleep Hygiene
- Being tested
- Sleep Hygiene Education
- Medical subject headings
- Cardiovascular Diseases, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Hygiene EducationBehavioural
This intervention consists of a nurse-led sleep hygiene education program delivered through a 30-minute PowerPoint presentation. Participants in the intervention group will also receive twice-daily reminder messages via WhatsApp for four weeks to reinforce healthy sleep habits. The program aims to improve sleep quality and disease management in individuals with cardiovascular disease. After the study, the educational materials will also be shared with the control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Sleep Hygiene Education |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Sleep Quality
This outcome measures the change in participants' sleep quality after the 4-week sleep hygiene education program. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, where higher scores indicate worse sleep quality and lower scores indicate better sleep quality. Data will be collected at baseline and after completion of the intervention.
Measured: 5 weeks (4 weeks intervention + final assessment in week 5)
Secondary outcomes (1)
Improvement in Disease Management
This outcome measures the change in participants' disease self-management ability after the 4-week sleep hygiene education program. Disease management will be assessed using the Chronic Disease Self-Management Scale (CDSMS). The CDSMS total score ranges from 0 to 100, with higher scores indicating better self-management and lower scores indicating poorer self-management. Data will be collected at baseline and after completion of the intervention.
Measured: 5 weeks (4 weeks intervention + final assessment in week 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start11 Sep 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease and Sleep HygieneStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Near East University, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Talaz, Near East University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135921
- Sponsor's protocol ID
- YDU-KARD-UYKU-2025-RCT
- Other IDs
- Near East University
- Acronym
- SLEEP-CARD
- Status last verified
- Aug 2025
- First submitted
- 8 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleep Hygiene Education on Disease Management and Sleep Quality in Individuals With Cardiovascular Diseases: A Randomized Controlled Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT07135921
- Acronym / sponsor ID
- SLEEP-CARD / YDU-KARD-UYKU-2025-RCT
- Conditions
- Cardiovascular Disease and Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Near East University, TurkeyUniversity, hospital or other
- Study start
- 11 Sep 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Aug 2025 (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.
This clinical trial aims to find out if sleep hygiene education helps people with cardiovascular disease manage their illness better and improve their sleep quality.
Participants will be randomly assigned to two groups. One group will receive sleep hygiene education through a 30-minute presentation and twice-daily reminder messages for four weeks. The other group will receive usual care without education.
Before and after the four-week period, all participants will complete questionnaires about their sleep habits, sleep quality, and disease management.
The study hopes to show that sleep hygiene education can improve participants' sleep and help them manage their disease symptoms better, leading to a better quality of life.
The trial will take place at Near East University Hospital's Cardiology Department from June to December 2025.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Sleep Hygiene Education |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Clinical diagnosis of cardiovascular disease at least one year prior
- No visual, hearing, communication, cognitive, or physical impairments
- Literate and able to use a smartphone and/or computer
- Willing to participate in the sleep hygiene education program
Key exclusion criteria (4 listed)
- Pregnancy
- Working night shifts
- Cognitive impairment preventing questionnaire completion
- Visual, hearing, communication, or physical impairments that prevent participation
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 |
|---|---|---|
| Sleep Hygiene EducationThis intervention consists of a nurse-led sleep hygiene education program delivered through a 30-minute PowerPoint presentation. Participants in the intervention group will also receive twice-daily reminder messages via WhatsApp for four weeks to reinforce healthy sleep habits. The program aims to improve sleep quality and disease management in individuals with cardiovascular disease. After the study, the educational materials will also be shared with the control group. | Behavioural | Intervention Group |
Primary outcome
Improvement in Sleep Quality
Time frame: 5 weeks (4 weeks intervention + final assessment in week 5)
This outcome measures the change in participants' sleep quality after the 4-week sleep hygiene education program. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score ranges from 0 to 21, where higher scores indicate worse sleep quality and lower scores indicate better sleep quality. Data will be collected at baseline and after completion of the intervention.
1 secondary outcome
Improvement in Disease Management
Time frame: 5 weeks (4 weeks intervention + final assessment in week 5)
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 24 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Hygiene Education in people with Cardiovascular Disease and Sleep Hygiene, run by Near East University, Turkey.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Sleep Quality (time frame: 5 weeks (4 weeks intervention + final assessment in week 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.