Heart FailureNCT06900504
"The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level"
A study testing Sleep hygiene education in people with Heart Failure, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to examine the effect of sleep hygiene education given to heart failure patients on the level of hospital-acquired insomnia of the patients. Participants will be randomly assigned to groups as experimental and control groups. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sleep hygiene education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2025to 30 May 2026
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years old
- Being literate
- Being a heart failure patient
- Being hospitalized for at least 1 week and staying for another week
- Not having a condition that prevents verbal communication
- Not having a diagnosed psychiatric problem
- Being a volunteer to participate in the research
Who cannot join
- Having a verbal communication disability
- Having a diagnosed psychiatric problem
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Atatürk University Research Hospital
Erzurum, 04100
Eda Ay, Dr, 04423446666, memnuniyet@atauni.edu.tr
Güzel Nur YILDIZ, Dr
About this study
Official title: "The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level": Randomized Controlled Trial
The purpose of this study is to examine the effect of sleep hygiene education given to heart failure patients on the level of hospital-acquired insomnia of the patients. Participants will be randomly assigned to groups as experimental and control groups. Standard application procedure will be applied to the control group. Sleep hygiene education will be given to the experimental group.
Research Hypotheses H0: Sleep hygiene education given to heart failure patients does not have a positive effect on the level of hospital-acquired insomnia of the patients.
H1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.
Read the detailed description
Heart failure (HF) is a life-threatening health problem. HF is considered a public health burden when the incidence, prevalence, healthcare expenditures, morbidity, mortality and poor quality of life are considered. Heart failure is prevalent in 6.5 million people in the United States, approximately 900,000 people are discharged from the hospital and more than 78,000 people die each year. HF, which has a high mortality and morbidity rate, has many symptoms. HF patients experience various physical and emotional complaints such as dyspnea, fatigue, edema, sleep disorders, depression and chest pain. Pharmacological and non-pharmacological treatment methods are used to improve sleep quality in chronic diseases. However, the inadequacy of pharmacological treatment methods and the fact that they cause various problems have brought non-pharmacological treatment methods to the forefront. One of the most frequently used methods in the non-pharmacological treatment of sleep problems is sleep hygiene training. The concept of sleep hygiene was first used by Peter Hauri. Sleep hygiene aims to provide behaviors that will ensure good sleep by avoiding individual behaviors that disrupt normal sleep patterns. The purpose of this study is to examine the effect of sleep hygiene education given to heart failure patients on the level of hospital-acquired insomnia of the patients. Participants will be randomly assigned to groups as experimental and control groups. Standard application procedure will be applied to the control group. Sleep hygiene education will be given to the experimental group.
Research Hypotheses H0: Sleep hygiene education given to heart failure patients does not have a positive effect on the level of hospital-acquired insomnia of the patients.
H1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.
- Conditions
- Heart Failure
- Being tested
- Sleep hygiene education
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene educationOther
A structured training booklet will be prepared to ensure sleep hygiene for individuals. In addition, sleep hygiene training will be provided to individuals.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Sleep hygiene education will be given to the experimental group. Receives: Other: Sleep hygiene education |
| Control Group | No intervention | Standard application procedure will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-acquired insomnia
Insomnia Score Average
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900504
- Sponsor's protocol ID
- muş alp
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Sleep Hygiene Training Given to Heart Failure Patients on Their HospitalAcquired Insomnia Level": Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06900504
- Acronym / sponsor ID
- muş alp
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 28 Mar 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.
The purpose of this study is to examine the effect of sleep hygiene education given to heart failure patients on the level of hospital-acquired insomnia of the patients. Participants will be randomly assigned to groups as experimental and control groups. Standard application procedure will be applied to the control group. Sleep hygiene education will be given to the experimental group.
Research Hypotheses H0: Sleep hygiene education given to heart failure patients does not have a positive effect on the level of hospital-acquired insomnia of the patients.
H1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.
Detailed description
Heart failure (HF) is a life-threatening health problem. HF is considered a public health burden when the incidence, prevalence, healthcare expenditures, morbidity, mortality and poor quality of life are considered. Heart failure is prevalent in 6.5 million people in the United States, approximately 900,000 people are discharged from the hospital and more than 78,000 people die each year. HF, which has a high mortality and morbidity rate, has many symptoms. HF patients experience various physical and emotional complaints such as dyspnea, fatigue, edema, sleep disorders, depression and chest pain. Pharmacological and non-pharmacological treatment methods are used to improve sleep quality in chronic diseases. However, the inadequacy of pharmacological treatment methods and the fact that they cause various problems have brought non-pharmacological treatment methods to the forefront. One of the most frequently used methods in the non-pharmacological treatment of sleep problems is sleep hygiene training. The concept of sleep hygiene was first used by Peter Hauri. Sleep hygiene aims to provide behaviors that will ensure good sleep by avoiding individual behaviors that disrupt normal sleep patterns. The purpose of this study is to examine the effect of sleep hygiene education given to heart failure patients on the level of hospital-acquired insomnia of the patients. Participants will be randomly assigned to groups as experimental and control groups. Standard application procedure will be applied to the control group. Sleep hygiene education will be given to the experimental group.
Research Hypotheses H0: Sleep hygiene education given to heart failure patients does not have a positive effect on the level of hospital-acquired insomnia of the patients.
H1: Sleep hygiene education given to heart failure patients has a positive effect on the level of hospital-acquired insomnia of the patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Sleep hygiene educationSleep hygiene education will be given to the experimental group. |
| Control Group | No intervention | –Standard application procedure will be applied to the control group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being over 18 years old
- Being literate
- Being a heart failure patient
- Being hospitalized for at least 1 week and staying for another week
- Not having a condition that prevents verbal communication
Key exclusion criteria (2 listed)
- Having a verbal communication disability
- Having a diagnosed psychiatric problem
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 educationA structured training booklet will be prepared to ensure sleep hygiene for individuals. In addition, sleep hygiene training will be provided to individuals. | Other | Experimental Group |
Primary outcome
Hospital-acquired insomnia
Time frame: 1 months
Insomnia Score Average
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 28 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene education in people with Heart Failure, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
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 7 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: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-acquired insomnia (time frame: 1 months). 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 28 Mar 2025.