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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to improve sleep for patients with neurological conditions while in the hospital. It examines the use of a patient sleep menu and a special sleep-friendly order set to create a more conducive sleep environment. Researchers will track sleep patterns using FitBits and ask patients about changes in their sleep quality. Patients who have been in the hospital for over 24 hours and are stable without needing frequent checks might be suitable candidates. The goal is to determine if these interventions can enhance sleep during hospital stays. As an unphased study, this trial allows patients to contribute to innovative research that could improve hospital care for future patients.

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 prior data suggests that these sleep interventions are safe for neurology inpatients?

Research has shown that the sleep-friendly methods being tested are generally safe and easy for patients to manage. These methods aim to improve hospital environments for sleep. Studies have found that implementing a sleep-friendly plan can reduce nighttime disturbances, such as unnecessary room visits, without causing harm. This leads to fewer sleep interruptions and better overall sleep quality for patients.

Another method under evaluation is the patient sleep menu, which allows patients to choose options that might help them sleep better. Previous research suggests these methods are safe and aim to enhance the hospital experience by reducing the need for sleep-inducing drugs.

Overall, these methods focus on improving sleep without adding risk to patient safety. They aim to enhance hospital care by creating a more restful environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sleep improvement interventions for inpatients with neurological conditions because they focus on non-pharmacological strategies that could enhance patient care without the side effects of medication. Unlike traditional treatments that often rely on sedatives or other drugs to aid sleep, these interventions include a "patient sleep menu" and a "sleep-friendly order set," which aim to create a more restful hospital environment tailored to individual needs. By optimizing the hospital setting and routines for better sleep, these methods could provide a safer, more personalized approach to improving sleep quality, ultimately benefiting recovery and overall well-being.

What evidence suggests that these sleep interventions could be effective for neurology inpatients?

Research shows that a sleep-friendly routine and a sleep menu can help neurology patients sleep better in the hospital. In this trial, participants in the sleep intervention arm will experience these changes, which studies have found lead to fewer interruptions at night. Patients have reported better sleep with these improvements. By making the hospital environment more restful, these strategies aim to enhance overall sleep health. Early evidence suggests that changing hospital routines can significantly improve patient sleep quality. ^{1 3 5 6 7}

Who Is on the Research Team?

Laura Stein

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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 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 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]

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]

Citations

1. withpower.com withpower.com/trial/phase-sleep-3-2023-a1260

Sleep Improvement Interventions for Inpatients with ... We aim to test multiple interventions to improve sleep for Neurology inpatients, including 1) a sleep-friendly order set, and 2) a sleep menu.

2. neurology.org neurology.org/doi/10.1212/CPJ.0000000000200492

Promoting Sleep for Neurology Inpatients These studies reported fewer nighttime disruptions and improvements in patient-reported sleep measures.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827235

Design and Implementation of Sleep Health Interventions ... This quality improvement project is an exemplar for the design of interventions to improve sleep in the hospital setting.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11602248/

Nudging towards Sleep-Friendly Health Care This study aimed to evaluate an intervention to promote sleep-friendly practices by optimizing choice architecture and employing targeted nudges on inpatient ...

5. researchgate.net researchgate.net/publication/383469493_Nudging_Towards_Sleep-Friendly_Hospitalizations_A_Multifaceted_Approach_on_Reducing_Unnecessary_Overnight_Interventions

(PDF) Nudging Towards Sleep-Friendly Hospitalizations Study objectives: This study sought to investigate perceptions of sleep disruptions among patients and staff in the inpatient neurology setting.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06094699

Improving Sleep in the Neurology In-Patient Population 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10715790/

Promoting a Sleep-friendly Environment by Minimizing ... This quality improvement intervention aimed to reduce overnight room entries by minimizing unnecessary interventions.