Cardiovascular DiseasesNCT07130201
Sleep and Automatic Dysfunction in Elderly Cardiovascular Patients
An observational study of Cardiovascular Diseases, run by Assiut University.
Trial summary
This study explores the relationship between sleep disorders and autonomic dysfunction in elderly patients with cardiovascular disease. It examines common risk factors such as aging-related physiological changes, comorbidities, and lifestyle factors, and discusses how disturbances in sleep and autonomic regulation can… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 20 Dec 2027
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with cardiovascular diseases more than 65 years old
Who may be able to join
- Patients will be recruited from the outpatient clinic (to include stable patients) Age ≥ 65 years Clinically diagnosed cardiovascular disease (e.g., heart failure, atrial fibrillation, coronary artery disease) Able to provide informed consent
Who cannot join
- Diagnosed neurodegenerative diseases (e.g., advanced dementia) Use of sedatives/hypnotics in the past 2 weeks Terminal illness or palliative care status
About this study
Official title: Sleep Disorders and Automatic Dysfunction in Elderly Cardiovascular Patients: Risk Factors and Clinical Implications "
This study explores the relationship between sleep disorders and autonomic dysfunction in elderly patients with cardiovascular disease. It examines common risk factors such as aging-related physiological changes, comorbidities, and lifestyle factors, and discusses how disturbances in sleep and autonomic regulation can worsen cardiovascular outcomes. The work also outlines potential clinical implications, including the importance of early screening, integrated management strategies, and targeted interventions to improve both cardiovascular health and quality of life in this vulnerable population.
- Conditions
- Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with cardiovascular diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep disturbance
Prevalence of sleep disturbance among elderly patients with cardiovascular diseases
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start20 Sep 2025 (estimated)
- Primary completion20 Aug 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa sedek Roshdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130201
- Sponsor's protocol ID
- SD_AD_ECP
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disorders and Automatic Dysfunction in Elderly Cardiovascular Patients: Risk Factors and Clinical Implications "
- ClinicalTrials.gov ID
- NCT07130201
- Acronym / sponsor ID
- SD_AD_ECP
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 20 Aug 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 19 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 study explores the relationship between sleep disorders and autonomic dysfunction in elderly patients with cardiovascular disease. It examines common risk factors such as aging-related physiological changes, comorbidities, and lifestyle factors, and discusses how disturbances in sleep and autonomic regulation can worsen cardiovascular outcomes. The work also outlines potential clinical implications, including the importance of early screening, integrated management strategies, and targeted interventions to improve both cardiovascular health and quality of life in this vulnerable population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients with cardiovascular diseases |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with cardiovascular diseases more than 65 years old
Key inclusion criteria (1 listed)
- Patients will be recruited from the outpatient clinic (to include stable patients) Age ≥ 65 years Clinically diagnosed cardiovascular disease (e.g., heart failure, atrial fibrillation, coronary artery disease) Able to provide informed consent
Key exclusion criteria (1 listed)
- Diagnosed neurodegenerative diseases (e.g., advanced dementia) Use of sedatives/hypnotics in the past 2 weeks Terminal illness or palliative care status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of sleep disturbance
Time frame: Baseline
Prevalence of sleep disturbance among elderly patients with cardiovascular diseases
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 23 Sep 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?
An observational study of Cardiovascular Diseases, run by Assiut University.
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 1 inclusion and 1 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 23 Sep 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?
Prevalence of sleep disturbance (time frame: Baseline). 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 23 Sep 2025.