Sleep Improvement Interventions for Inpatients with Neurological Conditions

(I_SLEEP Trial)

Overseen By Nichole Gallatti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Medical, psychological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 10 days

145 Participants Needed

Trial Summary

What is the purpose of this trial?

We aim to test multiple interventions to improve sleep for Neurology inpatients, including 1) a sleep-friendly order set, and 2) a sleep menu. We will collect patient sleep data, including duration and quality, via actigraphy devices (FitBits). We will also conduct qualitative patient surveys to understand the impact of these interventions.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What data supports the idea that Sleep Improvement Interventions for Inpatients with Neurological Conditions is an effective treatment?

The available research shows that Sleep Improvement Interventions, like the 'sleep menu', are effective in improving patients' sleep in hospitals. For example, in one study, the percentage of patients who reported getting five or more hours of uninterrupted sleep increased from 31% to 80% after the introduction of a sleep menu. This improvement was maintained over three months and also led to better patient satisfaction scores. Another study found that a program called SIESTA, which helps reduce nighttime disruptions, increased the use of sleep-friendly practices in hospitals. These interventions not only help patients sleep better but also improve their overall hospital experience. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Sleep Improvement Interventions for Inpatients with Neurological Conditions?

Research shows that similar sleep-friendly interventions, like the 'sleep menu' in a hospital setting, significantly improved patients' sleep quality, with the percentage of patients reporting five or more hours of uninterrupted sleep rising from 31% to 80%. This suggests that structured sleep interventions can enhance sleep quality in hospital environments. ^{1 2 3 4 5}

What safety data exists for sleep improvement interventions in hospitals?

The research does not directly provide specific safety data for sleep improvement interventions like the Sleep Menu or Sleep-Friendly Interventions. However, studies such as SIESTA and I-SLEEP focus on improving patient sleep through educational and environmental changes, which are generally non-invasive and suggest a low risk of adverse effects. The interventions aim to reduce nighttime disruptions and improve sleep quality, which can enhance patient recovery and satisfaction without introducing significant safety concerns. ^{2 3 4 6 7}

Is the Sleep Improvement Intervention safe for inpatients with neurological conditions?

The Sleep Improvement Interventions, such as the Sleep Menu and SIESTA, have been implemented in hospitals to improve patient sleep without reported safety concerns. These interventions focus on reducing nighttime disruptions and have shown benefits in patient care experiences and outcomes. ^{2 3 4 6 7}

Is the treatment in the trial 'Sleep Improvement Interventions for Inpatients with Neurological Conditions' a promising treatment?

Yes, the treatment seems promising because it focuses on improving sleep for patients in hospitals by using strategies like reducing nighttime disruptions and educating staff. This approach has shown to increase sleep-friendly practices, which can help patients rest better. ^{2 8 9 10 11}

How does the SIESTA treatment for improving sleep in neurological inpatients differ from other treatments?

The SIESTA treatment is unique because it uses electronic reminders to reduce nighttime disruptions like vital checks and medication administration, combined with staff education to improve patient sleep, unlike other treatments that may focus solely on environmental changes or medication. ^{2 8 9 10 11}

Research Team

Laura Stein

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 who have been admitted to the general neurology ward at the Hospital of the University of Pennsylvania and are stable enough not to need overnight vital signs or neurological checks. They must be symptomatically stable for more than 24 hours and able to give verbal consent.

Inclusion Criteria

24 hours after admission to the general neurology (ward) service at the Hospital of the University of Pennsylvania

Patients who are determined by the primary team to be clinically stable enough to forego serial overnight vital signs monitoring and neuro checks.

My symptoms have been stable for more than 24 hours after being admitted.

Exclusion Criteria

Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Any additional clinical factors felt by the team to be incompatible with specific orders including requiring serial vital signs monitoring and neuro checks overnight

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive sleep interventions including a sleep-friendly order set and a sleep menu, with sleep data collected via actigraphy devices (FitBits)

Up to 10 days

In-patient stay

Follow-up

Participants are monitored for sleep quality and duration using surveys and actigraphy data

1 week

Treatment Details

Interventions

• Patient sleep menu
• Sleep-friendly order set

Trial Overview The study tests two interventions aimed at improving sleep quality in neurology inpatients: a set of orders designed with sleep in mind, and a menu tailored to promote better sleep. Sleep data will be tracked using FitBits, and patient surveys will assess these interventions' effectiveness.

Participant Groups

Group I: Sleep intervention Experimental Treatment 2 Interventions

Group II: Standard of care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

A study involving nursing interventions to promote sleep quality in hospitalized patients showed that the intervention group reported better sleep, particularly among men, highlighting the potential effectiveness of targeted sleep support.

The findings suggest that pain intensity is linked to sleep quality, and emphasize the need for individualized sleep care plans and training for nurses to enhance patients' sleep during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep improvement intervention and its effect on patients' sleep on the ward. Ritmala-Castren, M., Salanterä, S., Holm, A., et al.[2021]

The SIESTA program, which included electronic nudges and staff education, significantly increased the adoption of sleep-friendly practices in a hospital unit, leading to a rise in orders to forgo nighttime vital signs and medications.

Patients in the SIESTA-enhanced unit experienced 44% fewer nighttime disruptions and reported better sleep quality, indicating that empowering nursing staff to prioritize patient sleep can enhance the overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of SIESTA on Objective and Subjective Metrics of Nighttime Hospital Sleep Disruptors. Arora, VM., Machado, N., Anderson, SL., et al.[2020]

The I-SLEEP intervention, which includes educational materials and tools for patients, was well-received by hospitalized patients, with 90% satisfaction reported for the brochure and 87% for the video.

Patients who engaged with the I-SLEEP program were significantly more likely to experience fewer nighttime disruptions, suggesting that empowering patients to advocate for their sleep can improve their hospital experience and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piloting I-SLEEP: a patient-centered education and empowerment intervention to improve patients' in-hospital sleep. Mason, NR., Orlov, NM., Anderson, S., et al.[2021]

A holistic 'sleep menu' intervention at a community hospital significantly improved patient sleep quality, with the percentage of patients reporting five or more hours of uninterrupted sleep increasing from 31% to 80%.

The intervention not only enhanced patient care experiences but also improved the hospital's quiet-at-night score on the HCAHPS survey from 1 to 4, demonstrating its effectiveness in addressing noise-related complaints in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Quiet at Night on a Telemetry Unit: Introducing a Holistic Sleep Menu Intervention. Antonio, CK.[2021]

Implementing a Sleep Program in the surgical intensive care unit significantly improved patient satisfaction with sleep by 28 percentage points, highlighting the importance of a healing environment for hospitalized patients.

The project focused on changing sleep management practices based on evidence-based approaches, which can lead to better healing and reduced stress for stable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. Hata, RK., Han, L., Slade, J., et al.[2014]

Inpatient sleep loss can lead to serious health issues like delirium and falls, highlighting the importance of sleep in hospital settings.

Optimizing clinical decision support systems in electronic health records can reduce unnecessary sleep disruptions for patients, promoting better sleep and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspective: leveraging the electronic health record to improve sleep in the hospital. Kadura, S., Siala, T., Arora, VM.[2023]

The Factors Affecting Inpatient Sleep (FAIS) scale was developed and validated to identify specific sleep disruptors for hospitalized patients, consisting of 14 items across three subscales.

The FAIS scale demonstrated strong reliability (Cronbach's alpha of 0.87) and can be used to create personalized sleep promotion plans tailored to individual patient needs, addressing factors like emotional impairment, discomfort, and environmental interruptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized sleep promotion in acute care hospitals: Identifying factors that affect patient sleep. Ye, L., Owens, RL., Dykes, P.[2021]

A structured bedtime program for children in inpatient units can significantly improve their sleep quality by addressing their specific nighttime needs.

Implementing this program helps alleviate staff exhaustion and enhances emotional availability, leading to a more supportive environment for children during bedtime.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting the unit to bed. Delaney, KR.[2008]

A systematic review of 17 studies found that nurse-led interventions can significantly improve sleep quality in hospitalized patients, with 14 studies showing positive results.

Despite the overall positive findings, only four studies had a low risk of bias, indicating a need for higher quality research to better validate these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of nursing interventions on sleep quality in hospitalized patients: A systematic review of randomized controlled trials. Bellon, F., Mora-Noya, V., Pastells-Peiró, R., et al.[2021]

A systematic review of 43 studies involving 2713 hospitalized patients found that while nonpharmacological sleep interventions are needed, no specific intervention could be recommended due to the overall low quality of the studies.

Melatonin and cognitive behavioral therapy for insomnia (CBT-I) showed the most potential for improving sleep in hospital settings, along with simple environmental changes like quiet time and the use of ear plugs and eye masks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleepless in the hospital: A systematic review of non-pharmacological sleep interventions. Miller, MA., Renn, BN., Chu, F., et al.[2020]

The 'TUCK-in' protocol, a non-pharmacologic intervention aimed at improving sleep quality for hospitalized patients, did not result in significant improvements in self-reported night-time sleep duration or other sleep quality measures compared to a control group of patients.

Despite the lack of measurable benefits in sleep outcomes, staff found the implementation of the protocol to be feasible and valuable, suggesting that while the intervention may not have improved sleep, it could still be beneficial in other ways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-pharmacologic interventions to improve sleep of medicine inpatients: a controlled study. Dobing, S., Dey, A., McAlister, F., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Sleep improvement intervention and its effect on patients' sleep on the ward. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of SIESTA on Objective and Subjective Metrics of Nighttime Hospital Sleep Disruptors. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Piloting I-SLEEP: a patient-centered education and empowerment intervention to improve patients' in-hospital sleep. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Improving Quiet at Night on a Telemetry Unit: Introducing a Holistic Sleep Menu Intervention. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Perspective: leveraging the electronic health record to improve sleep in the hospital. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Individualized sleep promotion in acute care hospitals: Identifying factors that affect patient sleep. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Putting the unit to bed. [2008]

9. England pubmed.ncbi.nlm.nih.gov

The efficacy of nursing interventions on sleep quality in hospitalized patients: A systematic review of randomized controlled trials. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Sleepless in the hospital: A systematic review of non-pharmacological sleep interventions. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Non-pharmacologic interventions to improve sleep of medicine inpatients: a controlled study. [2020]