ClinicalTrials.gg
CompletedNCT07747597Heart failureUpdated Nov 4, 2026

Effect of a Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies on Sleep Quality Among Patients With Chronic Heart Failure

An interventional study of Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies in Chronic Heart Failure (CHF), sponsored by Al-Zaytoonah University of Jordan. Completed at 1 site in Jordan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Al-Zaytoonah University of Jordan · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Dec 2025, registered Jul 2026).
Updated Nov 4, 2026Start date movedPrimary completion moved+5 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Heart Failure (CHF)

Keywords

  • Chronic Heart Failure, Sleep Quality, Sleep Hygiene, Cognitive-Behavioral Strategies
03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's enrollment of 100 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Al-Zaytoonah University of Jordan is the lead sponsor of 31 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged 18 to 65 years.
  • Diagnosed with chronic heart failure for at least 6 months according to the (NYHA) classification.
  • Experiencing poor sleep quality as indicated by a score >5 on the Pittsburgh Sleep Quality Index during the previous month.

Exclusion criteria

Exclusion Criteria

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Structured Nursing Intervention

    Participants receive the structured nursing intervention incorporating sleep hygiene education and cognitive-behavioral strategies in addition to usual care.

    Behavioral: Structured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies

  • No intervention
    Routine Care

    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.

Interventions

  • BehavioralStructured Nursing Intervention Incorporating Sleep Hygiene and Cognitive-Behavioral Strategies

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At baseline (before the intervention) and one week after completion of the four-week nursing intervention.

07

Study locations

1 site
  • Menoufia University Hospitals
    Amman, 00000, Jordan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2025 to primary completion in Jun 2026, 5 months.

Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's 5 months is below that.

Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: start Jun 2025 → Dec 2025, primary completion Dec 2025 → Jun 2026 and completion Apr 2026 → Jun 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2026
First posted
Aug 5, 2026
StartActual
Dec 8, 2025was Jun 2025
Primary completionActual
Jun 5, 2026was Dec 2025
CompletionActual
Jun 7, 2026was Apr 2026
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Menoufia University Hospitals · Amman, Jordan
Show 1 removed
  • Al zaytoonah University · Amman, Jordan
Nov 4, 2026
Start date
Jun 8, 2025→Dec 8, 2025
Nov 4, 2026
Primary completion
Dec 5, 2025→Jun 5, 2026
Nov 4, 2026
Study completion
Apr 7, 2026→Jun 7, 2026
Nov 4, 2026
Eligibility
Minimum age 20 Years→18 Years; Maximum age none→65 Years
Nov 4, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Sleep QualityNow Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)Time frame: Baseline and 3 months after completion of the intervention. → At baseline (before the intervention) and one week after completion of the four-week nursing intervention.
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    1 site added, 1 site removed
    Show site
    • Menoufia University Hospitals · Amman, Jordan
    Show 1 removed
    • Al zaytoonah University · Amman, Jordan
    Start date Jun 8, 2025→Dec 8, 2025
    Primary completion Dec 5, 2025→Jun 5, 2026
    Study completion Apr 7, 2026→Jun 7, 2026
    Eligibility Minimum age 20 Years→18 Years; Maximum age none→65 Years
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Sleep QualityNow Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)Time frame: Baseline and 3 months after completion of the intervention. → At baseline (before the intervention) and one week after completion of the four-week nursing intervention.
    + 2 other changes: verification date and responsible party

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07747597
Lead sponsor
Al-Zaytoonah University of Jordan
Responsible party
Eman Abdelfatah Shokr (Dr, Menoufia University) — Principal investigator
First posted
Aug 5, 2026
Start date
Dec 8, 2025
Primary completion
Jun 5, 2026
Completion
Jun 7, 2026
Last update
Nov 4, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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