Nurse Based Care ManagementNCT07265713
Bring Sleep to Life - Evaluation and Description of a Sleep Intervention in Emergency Care
A study testing Knowledge about sleep guideline and Introduction of web-based sleep education in people with Nurse Based Care Management and Patient Care, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Many patients complain of poor sleep during their hospital stay. Therefore, we want to investigate how we can improve the staff's (nurses and assistant nurses) knowledge about sleep and which nursing interventions can lead to improved sleep during their hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nurse Based Care Management, Patient Care, Intervention
- What is being tested?
- Knowledge about sleep guideline and Introduction of web-based sleep education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 15 Apr 2024to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Registered nurse with area responsibility for sleep
- Held the assignment for responsibility for sleep at least six months.
- Working at Theme Heart, Vascular and Neurology in Karolinska University Hospital
- On-line survey staff:
- Clinically active staff (nurse, assistant nurse) at the intervention departments within Theme Heart, Vascular and Neurology
- Control group:
Show all 12Show fewer
- Clinically active staff (nurse, assistant nurse) at Theme Cancer Karolinska University Hospital
- No access to the guideline for sleep, and digital sleep education programme
- Patients´ experiences:
- Hospitalized for at least one night in the intervention departments
- Understand the Swedish language both spoken and written
- Age over 18 years
Who cannot join
- Diagnosis of cognitive impairment
- Delirium
- Failing vital parameters as low blood pressure
- Severe visual impairment that makes it impossible to complete the questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Many patients complain of poor sleep during their hospital stay. Therefore, we want to investigate how we can improve the staff's (nurses and assistant nurses) knowledge about sleep and which nursing interventions can lead to improved sleep during their hospital stay.
The intervention are in three parts:
a clinical guideline introduction of sleep nursing champions a web-based educational course
Read the detailed description
A majority of hospitalised have reported being awakened due to external factors, of which being disturbed by hospital staff was the most common. It is therefore essential to provide nursing staff with the knowledge and tools to promote patients' sleep during hospitalisation. For this purpose, an intervention was developed to aid nursing staff in adopting evidence-based, non-pharmacological methods to promote sleep. The intervention comprises three parts: a web-based educational course, a clinical guideline and the introduction of sleep nursing champions (SNCs) at the intervention units.
- Conditions
- Nurse Based Care Management, Patient Care, Intervention, Education, Professional, Guideline Implementation
- Being tested
- Knowledge about sleep guideline, Introduction of web-based sleep education
- Keywords
- Sleep, Sleep promotion, Education, Inpatient, In-real life study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge about sleep guidelineOther
The sleep guideline has been available since 2021, but it is unknown whether healthcare professionals are aware of this guideline. And whether it is used in clinical practice.
Introduction of web-based sleep educationOther
The web-based interactive sleep training course to increase knowledge about sleep for hospital staff.
| Study group | Role | What they receive |
|---|---|---|
| Introduction of sleep nursing champions (SNCs) | Other | To describe sleep nurses' experiences of working with sleep-promoting nursing and to describe their experiences of having sleep as an area of responsibility within nursing. Receives: Other: Knowledge about sleep guideline; Other: Introduction of web-based sleep education |
| Sleep guideline and web-based sleep training education | Other | On-line survey to evaluate the introduction of a sleep guideline and a web-based sleep training aimed at staff in nursing wards. Receives: Other: Knowledge about sleep guideline; Other: Introduction of web-based sleep education |
| Patients experience | No intervention | On-line survey description from patients' perspectives about sleep in connection with hospital care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the role of a sleep nurse champions (SNC)
Individual semi-structured interviews with sleep nursing champions (SNC) to investigate their experience about the role as SNC:
- Description of the tasks as a SNC.
- Identify characteristics that are important for being a SNC
- Identify success factors in the assignment
- Identify obstacles or setbacks in the assignment
- Identify the areas of nursing that are important to develop to promote patients' sleep
- Need for sleep as an area of nursing
- Existence of support from your immediate manager, colleagues, other professional groups or the project group.
- Changes in how you think patients' sleep is affected by the introduction of a SNC in your department
- Perceptions of patients' sleep in connection with hospital care
- SNC knowledge of sleep and health-related quality of life linked and how.
We also collect demographic data: age of participants, number of years as a nurse, employed at department and orks: day or three shifts or night only.
Measured: Individual interviews on one occasion. Time required max. 60 minutes. Total 13 SNC.
Web-based survey on sleep knowledge and awareness of online sleep training and sleep guidelines
The survey consists of questions about:
Intervention units:
- General knowledge about sleep and factors that affect patients' sleep in hospitals
- Specific sleep questions about sleep and sleep-promoting measures according to the online training program and guideline
- If sleep is prioritized in the clinic and for the individual.
Control units:
- General questions about sleep and sleep-promoting measures in acute care.
There is also the possibility to develop the answers given in the survey through so-called free text answers.
We also collect demographic data: professional title/profession, number of years in the profession, age, gender, and which theme/department you work in.
At the intervention units we also collect data about whether you have completed sleep training, and whether you have read the sleep guideline.
Measured: The survey is completed once. It takes approximately 15 minutes.
Inpatients' experiences of sleeping in hospital
Web-based or printed paper questionnaire survey:
- Increase knowledge about patients' experiences of sleep in hospitals.
- Investigate patients' experiences of staff's work to promote patients' sleep.
There is also the possibility to develop the answers given in the survey through so-called free text answers.
We also collect demographic data as: date of birth, gender, marital status, education level, use of sleep medication, hospital ward, single or multi-bed room.
Measured: The questionnaire is completed once during the hospitalisation. Time required is a maximum of 20-30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start15 Apr 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nurse Based Care ManagementStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Guideline, on-line education
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arja Vehkala Höglund, Karolinska University Hospital
- Investigators
- Linda Gellerstedt, RN, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265713
- Sponsor's protocol ID
- Dnr 2023-04670-01
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Nilsson O, Vehkala-Hoglund A, Gellerstedt L. Evidence-based sleep promotion in acute care from the perspective of nursing staff: a cross-sectional study. BMC Nurs. 2026 Jan 5;25(1):32. doi: 10.1186/s12912-025-04259-3.
PubMed 41491189
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bring Sleep to Life - Evaluation and Description of a Sleep Intervention in Emergency Care
- ClinicalTrials.gov ID
- NCT07265713
- Acronym / sponsor ID
- Dnr 2023-04670-01
- Conditions
- Nurse Based Care Management, Patient Care, Intervention, Education, Professional, Guideline Implementation
- Keywords
- Sleep, Sleep promotion, Education, Inpatient, In-real life study
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 Dec 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.
Many patients complain of poor sleep during their hospital stay. Therefore, we want to investigate how we can improve the staff's (nurses and assistant nurses) knowledge about sleep and which nursing interventions can lead to improved sleep during their hospital stay.
The intervention are in three parts:
a clinical guideline introduction of sleep nursing champions a web-based educational course
Detailed description
A majority of hospitalised have reported being awakened due to external factors, of which being disturbed by hospital staff was the most common. It is therefore essential to provide nursing staff with the knowledge and tools to promote patients' sleep during hospitalisation. For this purpose, an intervention was developed to aid nursing staff in adopting evidence-based, non-pharmacological methods to promote sleep. The intervention comprises three parts: a web-based educational course, a clinical guideline and the introduction of sleep nursing champions (SNCs) at the intervention units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Guideline, on-line education
| Arm | Type | Receives |
|---|---|---|
| Introduction of sleep nursing champions (SNCs) | Other | Other: Knowledge about sleep guideline, Other: Introduction of web-based sleep educationTo describe sleep nurses' experiences of working with sleep-promoting nursing and to describe their experiences of having sleep as an area of responsibility within nursing. |
| Sleep guideline and web-based sleep training education | Other | Other: Knowledge about sleep guideline, Other: Introduction of web-based sleep educationOn-line survey to evaluate the introduction of a sleep guideline and a web-based sleep training aimed at staff in nursing wards. |
| Patients experience | No intervention | –On-line survey description from patients' perspectives about sleep in connection with hospital care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Registered nurse with area responsibility for sleep
- Held the assignment for responsibility for sleep at least six months.
- Working at Theme Heart, Vascular and Neurology in Karolinska University Hospital
- Clinically active staff (nurse, assistant nurse) at the intervention departments within Theme Heart, Vascular and Neurology
- Clinically active staff (nurse, assistant nurse) at Theme Cancer Karolinska University Hospital
Key exclusion criteria (4 listed)
- Diagnosis of cognitive impairment
- Delirium
- Failing vital parameters as low blood pressure
- Severe visual impairment that makes it impossible to complete the questionnaire
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 |
|---|---|---|
| Knowledge about sleep guidelineThe sleep guideline has been available since 2021, but it is unknown whether healthcare professionals are aware of this guideline. And whether it is used in clinical practice. | Other | Introduction of sleep nursing champions (SNCs), Sleep guideline and web-based sleep training education |
| Introduction of web-based sleep educationThe web-based interactive sleep training course to increase knowledge about sleep for hospital staff. | Other | Introduction of sleep nursing champions (SNCs), Sleep guideline and web-based sleep training education |
Primary outcome
Description of the role of a sleep nurse champions (SNC)
Time frame: Individual interviews on one occasion. Time required max. 60 minutes. Total 13 SNC.
Individual semi-structured interviews with sleep nursing champions (SNC) to investigate their experience about the role as SNC: * Description of the tasks as a SNC. * Identify characteristics that are important for being a SNC * Identify success factors in the assignment * Identify obstacles or setbacks in the assignment * Identify the areas of nursing that are important to develop to promote patients' sleep * Need for sleep as an area of nursing * Existence of support from your immediate manager, colleagues, other professional groups or the project group. * Changes in how you think patients' sleep is affected by the introduction of a SNC in your department * Perceptions of patients' sleep in connection with hospital care * SNC knowledge of sleep and health-related quality of life linked and how. We also collect demographic data: age of participants, number of years as a nurse, employed at department and orks: day or three shifts or night only.
Web-based survey on sleep knowledge and awareness of online sleep training and sleep guidelines
Time frame: The survey is completed once. It takes approximately 15 minutes.
The survey consists of questions about: Intervention units: * General knowledge about sleep and factors that affect patients' sleep in hospitals * Specific sleep questions about sleep and sleep-promoting measures according to the online training program and guideline * If sleep is prioritized in the clinic and for the individual. Control units: • General questions about sleep and sleep-promoting measures in acute care. There is also the possibility to develop the answers given in the survey through so-called free text answers. We also collect demographic data: professional title/profession, number of years in the profession, age, gender, and which theme/department you work in. At the intervention units we also collect data about whether you have completed sleep training, and whether you have read the sleep guideline.
Inpatients' experiences of sleeping in hospital
Time frame: The questionnaire is completed once during the hospitalisation. Time required is a maximum of 20-30 minutes.
Web-based or printed paper questionnaire survey: * Increase knowledge about patients' experiences of sleep in hospitals. * Investigate patients' experiences of staff's work to promote patients' sleep. There is also the possibility to develop the answers given in the survey through so-called free text answers. We also collect demographic data as: date of birth, gender, marital status, education level, use of sleep medication, hospital ward, single or multi-bed room.
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 5 Dec 2025.
- Derived from this study: PubMed 41491189Nilsson O, Vehkala-Hoglund A, Gellerstedt L. Evidence-based sleep promotion in acute care from the perspective of nursing staff: a cross-sectional study. BMC Nurs. 2026 Jan 5;25(1):32. doi: 10.1186/s12912-025-04259-3.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Linda Gellerstedt, RN, PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge about sleep guideline and Introduction of web-based sleep education in people with Nurse Based Care Management and Patient Care, run by Karolinska University Hospital at 1 site in Sweden.
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 12 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: enrolling by invitation, as of the sponsor's last update on 5 Dec 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 Sweden. 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?
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?
Description of the role of a sleep nurse champions (SNC) (time frame: Individual interviews on one occasion. Time required max. 60 minutes. Total 13 SNC.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07265713, which also lists 1 linked publication.
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 5 Dec 2025.