Sleep Hygiene for Delirium

Recruiting at 4 trial locations

Overseen By Rejani Nair, BSN

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Farhaan S. Vahidy

Disqualifiers: Alcohol withdrawal, Substance withdrawal, Acute psychiatric illness, ICU admission, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

10890 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce delirium in hospitalized older adults by improving their sleep environment. The experimental treatment, known as the Multi-Modal Sleep Hygiene (MMSH) bundle, enhances the sleep setting by managing noise, light, staff interactions, daytime activity, and medication use. The goal is to improve patients' sleep at night and decrease the likelihood of delirium. This trial targets patients aged 70 and older, who are in non-critical condition and staying on specific hospital units. As an unphased trial, it offers patients the opportunity to contribute to innovative research that could enhance sleep and reduce delirium in older adults.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the MMSH Bundle is safe for hospitalized older adults?

Research has shown that the Multi-Modal Sleep Hygiene (MMSH) bundle is designed to help hospitalized patients sleep better. This sleep-focused care reduces confusion and disorientation, known as delirium, especially in older adults.

A previous study used a similar method in intensive care units, which improved patients' sleep and lowered their chances of developing delirium. Better sleep was linked to a reduced risk of experiencing delirium.

Regarding safety, no reports of serious side effects have emerged from this non-drug sleep approach. It focuses on simple changes to the hospital environment, like reducing noise and adjusting light levels, which patients generally tolerate well. This suggests that the MMSH bundle should be safe for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MMSH (Multi-Modal Sleep Hygiene) Bundle because it takes a comprehensive approach to improving sleep quality in hospitalized older adults, which could help reduce the burden of delirium. Unlike standard care, which often involves basic sleep guidelines or medications, the MMSH Bundle focuses on several key areas: reducing noise and light, enhancing staff-patient interactions, promoting daytime activity, and optimizing medication use. This holistic approach aligns with patient feedback and addresses sleep disruptions that affect people of all ages, not just those at high risk for delirium. By targeting these multiple factors, the MMSH Bundle has the potential to significantly enhance patient experience and outcome.

What evidence suggests that the MMSH Bundle is effective for reducing delirium in older adults?

Research has shown that the Multi-Modal Sleep Hygiene (MMSH) Bundle, which participants in this trial may receive, can greatly reduce delirium in older adults in hospitals. A past study found that a similar sleep-focused program cut ICU delirium by half. More than 90% of participants followed the program, indicating it is easy to use. The MMSH Bundle addresses issues like noise, light, and staff interactions, which can affect sleep. By improving sleep, the bundle aims to reduce delirium, offering a promising way to enhance hospital care. ^{1 2 3 6 7}

Who Is on the Research Team?

Farhaan Vahidy, PhD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for hospitalized adults aged 70 or older who may be at risk of delirium. The study aims to improve their sleep in the hospital setting to see if it helps prevent confusion and disorientation (delirium).

Inclusion Criteria

All races and ethnicities

Admitted to the pre-specified clinical units which are part of the study

I am 70 years or older and not critically ill.

Exclusion Criteria

Patients with active alcohol or substance withdrawal

I was admitted to the ICU and needed help with breathing.

Patients with acute psychiatric illness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the Multi-Modal Sleep Hygiene (MMSH) bundle in a randomized step-wedge cluster design across 11 nursing units

5 years

Continuous monitoring and assessments every 12 hours

Follow-up

Participants are monitored for safety and effectiveness after the implementation of the MMSH bundle

5 years

Assessments every 12 hours, up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• MMSH (Multi-Modal Sleep Hygiene) Bundle

Trial Overview The trial tests a Multi-Modal Sleep Hygiene (MMSH) Bundle designed to enhance sleep quality and reduce disturbances in the hospital environment, with hopes of cutting down cases of delirium by half.

How Is the Trial Designed?

Group I: MMSH (Multi-Modal Sleep Hygiene) Bundle Experimental Treatment 1 Intervention

We will implement an MMSH bundle, enhancing a previously reported sleep focused intervention, in order to increase quality/quantity of sleep during Z-time (i.e., 10pm to 5am) in our intervention units, subsequently mitigating the burden of delirium in hospitalized older adults. Our proposed intervention domains perfectly align with the expressed patient suggestions to improve patient experience. Sleep disruption issues were raised at similar rates across the age span suggesting our MMSH will positively impact patients of all ages, including those with lower risk of delirium. The intervention components are outlined below and a comparison to the current standard of care and the components that are relevant to the fidelity aspects of the study are highlighted in the table. The main focus of the sleep interventions will focus on Noise, Light, Staff-Patient Interactions, Daytime Activity and Medications.

Group II: Standard of Care Active Control 1 Intervention

This study arm reflects patients receiving standard of care treatment without any modification of in-hospital sleep environment

MMSH (Multi-Modal Sleep Hygiene) Bundle is already approved in United States for the following indications:

Approved in United States as MMSH Bundle for:

• Prevention of delirium in hospitalized older adults

Who Is Running the Clinical Trial?

Farhaan S. Vahidy

Lead Sponsor

Trials

1

Recruited

10,900+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Sleep interventions, particularly the use of dexmedetomidine, significantly reduce the incidence of delirium in ICU patients, with a relative risk of 0.43, indicating a strong protective effect against delirium compared to control groups.

Other non-pharmacological sleep interventions, such as light therapy and melatonin, did not show significant effectiveness in preventing delirium, suggesting that not all sleep strategies are beneficial in the ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of sleep interventions to reduce delirium in critically ill patients: A systematic review and meta-analysis. Teng, J., Qin, H., Guo, W., et al.[2023]

The review analyzed 44 studies on sleep hygiene practices and their effects on sleep outcomes, such as sleep duration and onset latency, highlighting the need for clearer connections between specific sleep hygiene elements and their impacts.

The findings were organized by age group and intervention type, providing evidence-based recommendations for effective sleep hygiene practices while identifying areas that need further research to improve sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What does sleep hygiene have to offer children's sleep problems? Hall, WA., Nethery, E.[2020]

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]

In a study of 70 hospitalized patients aged 65 and older, those with delirium exhibited significantly shorter sleep bouts and increased sleep fragmentation compared to those without delirium, suggesting a link between sleep patterns and delirium.

The findings indicate that sleep fragmentation, which was detected before clinical recognition of delirium, could potentially serve as a biomarker for predicting delirium in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectively measured sleep fragmentation is associated with incident delirium in older hospitalized patients: Analysis of data collected from an randomized controlled trial. Jaiswal, SJ., Kang, DY., Wineinger, NE., et al.[2021]

The Sleep Hygiene Index, tested on 632 subjects, shows that sleep hygiene behaviors are stable over time in a nonclinical population, indicating its reliability as a measurement tool.

The index is strongly correlated with sleep quality and somewhat with daytime sleepiness, supporting its validity in assessing sleep hygiene practices and their impact on overall sleep health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of sleep hygiene using the Sleep Hygiene Index. Mastin, DF., Bryson, J., Corwyn, R.[2022]

In a study involving 94 patients with acute brain injury, an intervention targeting sedation, sleep, pain, and mobilization did not significantly reduce the prevalence or duration of delirium compared to standard care.

Despite the high prevalence of delirium (90% in standard care and 88% in the intervention group), the intervention did not lead to improvements in ICU length of stay or one-year mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delirium prevalence and prevention in patients with acute brain injury: A prospective before-and-after intervention study. Larsen, LK., Møller, K., Petersen, M., et al.[2020]

Sleep and circadian interventions significantly reduce the incidence of postoperative delirium, with a pooled relative risk of 0.48 based on 13 trials, indicating that these strategies can be effective in preventing this condition after surgery.

Specific interventions like dexmedetomidine sedation and timed bright light exposure were particularly effective in decreasing the risk of delirium, highlighting the importance of targeting sleep and circadian health in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting sleep and circadian health may prevent postoperative delirium: A systematic review and meta-analysis of randomized clinical trials. Lu, Y., Li, YW., Wang, L., et al.[2020]

Medical residents in the ICU experience significant sleepiness after on-call shifts, with 70% showing severe sleepiness (mean sleep latency < 5 minutes) on the post-call day, despite averaging 7.15 hours of sleep before their shifts.

The study used objective measures like actigraphy and the modified multiple sleep latency test (MSLT) to assess sleepiness, highlighting that even with reduced work hours, the risk of severe sleepiness remains a critical concern for both resident safety and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleepiness in medical ICU residents. Reddy, R., Guntupalli, K., Alapat, P., et al.[2017]

Older adults (aged 65 and older) with sleep disruption at home are over three times more likely to develop postoperative delirium after elective surgery compared to those without sleep issues, based on a study of 101 participants.

While sleep disruption in the hospital also increases the risk of delirium, it is not as significant as the risk posed by sleep disruption at home, indicating that preoperative sleep quality is a critical factor in postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Disruption at Home As an Independent Risk Factor for Postoperative Delirium. Todd, OM., Gelrich, L., MacLullich, AM., et al.[2021]

A quality improvement intervention in a medical ICU involving sleep-promoting strategies led to significant reductions in perceived nighttime noise and the incidence of delirium/coma among 300 patients, indicating a positive impact on patient cognition and comfort.

While the intervention did not significantly improve overall perceived sleep quality, it was associated with a higher number of delirium/coma-free days, suggesting that the strategies implemented were effective in enhancing patient outcomes in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Kamdar, BB., King, LM., Collop, NA., et al.[2022]

A study of 167 urban minority adolescents revealed that 67% reported poor sleep quality, with females having over twice the odds of experiencing this issue compared to males.

The majority of participants (77%) expressed interest in a mind-body integrative health (MBIH) intervention to improve sleep, highlighting a significant opportunity to address sleep problems in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial stress, sleep quality and interest in mind-body integrative health sleep intervention among urban adolescents in the school-based health setting. Garbers, S., Suruki, C., Falletta, KA., et al.[2023]

The Multiple Sleep Latency Test (MSLT) is recommended for evaluating patients suspected of having narcolepsy or idiopathic hypersomnia, but it is not advised for diagnosing obstructive sleep apnea or other sleep disorders.

The Maintenance of Wakefulness Test (MWT) can be useful for assessing safety in individuals who struggle to stay awake, particularly in narcolepsy, but clinicians should not rely solely on its results to determine accident risk, emphasizing the need for comprehensive clinical judgment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice parameters for clinical use of the multiple sleep latency test and the maintenance of wakefulness test. Littner, MR., Kushida, C., Wise, M., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-delirium-5-2024-b5b89

Sleep Hygiene for Delirium The MMSH Bundle is unique because it focuses on improving sleep hygiene through a multi-modal approach, targeting factors like sedation, sleep, pain, and ...

2. pcori.org pcori.org/research-results/2023/comparing-effectiveness-intervention-reduce-sleep-disruption-versus-standard-care-prevent-and-reduce-delirium-among-hospitalized-older-adults

Comparing the Effectiveness of an Intervention To Reduce ... This study compares the clinical effectiveness of standard of care for delirium screening and prevention versus standard of care plus a ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24813132/

The effect of a multicomponent multidisciplinary bundle ... One hundred and sixty-seven and 171 patients were screened for delirium pre- and post-intervention, respectively. Compliance with the interventions was > 90%.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1322769624000295

Delirium prevention and management in an adult intensive ... This review synthesised and categorised evidence-based nonpharmacological interventions for delirium prevention and management in adult ICUs

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03247062

Sleep Bundle for Improving Sleep in ICU Patients The project " sleep bundle " aims at improving the sleep of the patients by the implementation of a multimodal intervention that consists in a ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39084668/

Intensive Care Unit Sleep Promotion Bundle To examine whether implementation of a sleep promotion bundle in the intensive care unit affects rates of delirium and agitation, restraint use, and length of ...

7. researchgate.net researchgate.net/publication/262231503_The_effect_of_a_multicomponent_multidisciplinary_bundle_of_interventions_on_sleep_and_delirium_in_medical_and_surgical_intensive_care_patients

The effect of a multicomponent multidisciplinary bundle ... Increases in sleep efficiency index were associated with a lower odds ratio of developing delirium (OR 0.90, 95% CI 0.84–0.97). The introduction ...