Chronic Heart Failure (CHF)Heart failureNCT07747597
Effect of a Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies on Sleep Quality Among Patients With Chronic Heart Failure
A study testing Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies in people with Chronic Heart Failure (CHF), run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
Trial summary
This study aims to evaluate the effectiveness of a structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies on improving sleep quality among patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Heart Failure (CHF)
- What is being tested?
- Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 8 Dec 2025to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 to 65 years.
- Diagnosed with chronic heart failure for at least 6 months according to the New York Heart Association (NYHA) classification.
- Experiencing poor sleep quality as indicated by a score >5 on the Pittsburgh Sleep Quality Index during the previous month.
Who cannot join
- Patients with diagnosed psychiatric disorders or severe cognitive impairment.
- Patients receiving sedative-hypnotic therapy initiated within the previous month.
- Patients diagnosed with obstructive sleep apnea requiring continuous positive airway pressure therapy.
- Patients participating in other behavioral intervention program
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effectiveness of a structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies on improving sleep quality among patients with chronic heart failure. Sleep disturbances are common in patients with chronic heart failure and are associated with poorer functional status, reduced quality of life, and increased healthcare utilization. Participants will receive a structured nursing intervention that includes education on healthy sleep practices and cognitive-behavioral techniques to improve sleep.
Read the detailed description
Chronic heart failure is a progressive cardiovascular condition that is frequently accompanied by sleep disturbances, including insomnia, fragmented sleep, and poor sleep quality. These sleep problems contribute to fatigue, impaired daily functioning, poor self-care, and reduced health-related quality of life. Although pharmacological treatment is essential for heart failure management, non-pharmacological interventions such as sleep hygiene education and cognitive-behavioral strategies have shown promise in improving sleep outcomes.
This study will evaluate the effectiveness of a structured nursing intervention that integrates sleep hygiene education with cognitive-behavioral strategies for improving sleep quality among patients with chronic heart failure. The intervention will be delivered by trained nurses through structured educational sessions and individualized counseling.
The sleep hygiene component includes education on maintaining a regular sleep schedule, optimizing the sleep environment, limiting caffeine and stimulating activities before bedtime, promoting physical activity appropriate to the patient's condition, and establishing healthy bedtime routines. The cognitive-behavioral component includes relaxation techniques, cognitive restructuring of maladaptive beliefs about sleep, stimulus control, and behavioral strategies to reduce sleep-related anxiety.
Participants will be assessed at baseline before the intervention and at predetermined follow-up intervals after completion of the program. The primary outcome is sleep quality measured using a validated sleep assessment instrument. Secondary outcomes may include fatigue, quality of life, daytime functioning, and adherence to recommended sleep practices. The findings of this study are expected to support the integration of evidence-based nursing interventions into routine care for patients with chronic heart failure to improve sleep and overall well-being.
- Conditions
- Chronic Heart Failure (CHF)
- Being tested
- Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies
- Keywords
- Chronic Heart Failure, Sleep Quality, Sleep Hygiene, Cognitive-Behavioral Strategies
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral StrategiesBehavioural
Participants assigned to the intervention group will receive a structured nurse-led program consisting of sleep hygiene education and cognitive-behavioral strategies in addition to usual care. The intervention includes education on healthy sleep practices, establishing regular sleep schedules, optimizing the sleep environment, relaxation techniques, cognitive restructuring of maladaptive beliefs about sleep, stimulus control, and behavioral strategies to improve sleep quality. The program is delivered through structured educational sessions and follow-up support according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Structured Nursing Intervention | Experimental | Participants receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies in addition to usual care. Receives: Behavioral: Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies |
| Routine Care | No intervention | Participants assigned to the control arm will receive the standard care routinely provided for patients with chronic heart failure, including routine medical management, nursing care, and follow-up according to hospital practice. They will not receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a standardized self-report questionnaire that evaluates sleep quality and sleep disturbances
Measured: At baseline (before the intervention) and one week after completion of the four-week nursing intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start8 Dec 2025
- Primary completion5 Jun 2026
- Study completion7 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart Failure (CHF)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive a structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies in addition to usual care, while the control group will receive usual care alone. Outcomes will be assessed at baseline and after completion of the intervention to compare changes in sleep quality between the two groups.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abdelfatah Shokr, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747597
- Sponsor's protocol ID
- ERCNMA 1000 / 68 / 163 / 25
- Acronym
- Heart failure
- Status last verified
- Oct 2025
- First submitted
- 31 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies on Sleep Quality Among Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT07747597
- Acronym / sponsor ID
- Heart failure / ERCNMA 1000 / 68 / 163 / 25
- Conditions
- Chronic Heart Failure (CHF)
- Keywords
- Chronic Heart Failure, Sleep Quality, Sleep Hygiene, Cognitive-Behavioral Strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 7 Jun 2026 (actual)
- First posted
- 5 Aug 2026 (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 aims to evaluate the effectiveness of a structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies on improving sleep quality among patients with chronic heart failure. Sleep disturbances are common in patients with chronic heart failure and are associated with poorer functional status, reduced quality of life, and increased healthcare utilization. Participants will receive a structured nursing intervention that includes education on healthy sleep practices and cognitive-behavioral techniques to improve sleep.
Detailed description
Chronic heart failure is a progressive cardiovascular condition that is frequently accompanied by sleep disturbances, including insomnia, fragmented sleep, and poor sleep quality. These sleep problems contribute to fatigue, impaired daily functioning, poor self-care, and reduced health-related quality of life. Although pharmacological treatment is essential for heart failure management, non-pharmacological interventions such as sleep hygiene education and cognitive-behavioral strategies have shown promise in improving sleep outcomes.
This study will evaluate the effectiveness of a structured nursing intervention that integrates sleep hygiene education with cognitive-behavioral strategies for improving sleep quality among patients with chronic heart failure. The intervention will be delivered by trained nurses through structured educational sessions and individualized counseling.
The sleep hygiene component includes education on maintaining a regular sleep schedule, optimizing the sleep environment, limiting caffeine and stimulating activities before bedtime, promoting physical activity appropriate to the patient's condition, and establishing healthy bedtime routines. The cognitive-behavioral component includes relaxation techniques, cognitive restructuring of maladaptive beliefs about sleep, stimulus control, and behavioral strategies to reduce sleep-related anxiety.
Participants will be assessed at baseline before the intervention and at predetermined follow-up intervals after completion of the program. The primary outcome is sleep quality measured using a validated sleep assessment instrument. Secondary outcomes may include fatigue, quality of life, daytime functioning, and adherence to recommended sleep practices. The findings of this study are expected to support the integration of evidence-based nursing interventions into routine care for patients with chronic heart failure to improve sleep and overall well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive a structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies in addition to usual care, while the control group will receive usual care alone. Outcomes will be assessed at baseline and after completion of the intervention to compare changes in sleep quality between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Structured Nursing Intervention | Experimental | Behavioral: Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral StrategiesParticipants receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies in addition to usual care. |
| Routine Care | No intervention | –Participants assigned to the control arm will receive the standard care routinely provided for patients with chronic heart failure, including routine medical management, nursing care, and follow-up according to hospital practice. They will not receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 to 65 years.
- Diagnosed with chronic heart failure for at least 6 months according to the New York Heart Association (NYHA) classification.
- Experiencing poor sleep quality as indicated by a score >5 on the Pittsburgh Sleep Quality Index during the previous month.
Key exclusion criteria (4 listed)
- Patients with diagnosed psychiatric disorders or severe cognitive impairment.
- Patients receiving sedative-hypnotic therapy initiated within the previous month.
- Patients diagnosed with obstructive sleep apnea requiring continuous positive airway pressure therapy.
- Patients participating in other behavioral intervention program
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 |
|---|---|---|
| Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral StrategiesParticipants assigned to the intervention group will receive a structured nurse-led program consisting of sleep hygiene education and cognitive-behavioral strategies in addition to usual care. The intervention includes education on healthy sleep practices, establishing regular sleep schedules, optimizing the sleep environment, relaxation techniques, cognitive restructuring of maladaptive beliefs about sleep, stimulus control, and behavioral strategies to improve sleep quality. The program is delivered through structured educational sessions and follow-up support according to the study protocol. | Behavioural | Structured Nursing Intervention |
Primary outcome
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
Time frame: At baseline (before the intervention) and one week after completion of the four-week nursing intervention.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a standardized self-report questionnaire that evaluates sleep quality and sleep disturbances
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure (CHF)
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies in people with Chronic Heart Failure (CHF), run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
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 3 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI) (time frame: At baseline (before the intervention) and one week after completion of the four-week nursing intervention.). 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 4 Nov 2026.