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

Trial Summary

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 data supports the effectiveness of the treatment MMSH Bundle for preventing delirium?

Research shows that sleep and circadian (body clock) interventions can significantly reduce the risk of delirium after surgery, with patients receiving these interventions experiencing less delirium compared to those who did not. This suggests that improving sleep quality, as the MMSH Bundle aims to do, may help prevent delirium. ^{1 2 3 4 5}

Is the Sleep Hygiene for Delirium treatment generally safe for humans?

The research on sleep hygiene practices suggests they are generally safe and stable over time, with strong links to improved sleep quality and modest links to reduced daytime sleepiness. ^{6 7 8 9 10}

How is the MMSH Bundle treatment different from other treatments 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 mobilization, which are not typically addressed together in standard delirium treatments. This comprehensive focus on sleep and related factors is designed to prevent delirium by reducing sleep fragmentation, a known contributor to delirium in hospitalized patients. ^{3 4 5 11 12}

What is the purpose of this trial?

The overall goal is to reduce the incidence and burden of delirium, as measured by the delirium burden index (DBI) among hospitalized older adults (≥70 years), by modifying the inpatient environment to decrease its sleep antagonism. The investigators propose to implement a multi-modal sleep hygiene (MMSH) bundle, an enhancement of a previously reported sleep-focused intervention which had 88 - 100% compliance for intervention components, and reduced ICU delirium by 50%.

Research Team

Farhaan Vahidy, PhD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

I am 70 years or older and not critically ill.

My sex does not limit my participation.

All races and ethnicities

Exclusion Criteria

Patients with active alcohol or substance withdrawal

Patients with acute psychiatric illness

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

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

Sleep Disruption at Home As an Independent Risk Factor for Postoperative Delirium. [2021]

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

The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. [2022]

3. England 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Promoting sleep and circadian health may prevent postoperative delirium: A systematic review and meta-analysis of randomized clinical trials. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Delirium prevalence and prevention in patients with acute brain injury: A prospective before-and-after intervention study. [2020]

6. Scotland 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

What does sleep hygiene have to offer children's sleep problems? [2020]

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

Practice parameters for clinical use of the multiple sleep latency test and the maintenance of wakefulness test. [2022]

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

Assessment of sleep hygiene using the Sleep Hygiene Index. [2022]

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

Sleepiness in medical ICU residents. [2017]

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

Effectiveness of sleep interventions to reduce delirium in critically ill patients: A systematic review and meta-analysis. [2023]

12. England pubmed.ncbi.nlm.nih.gov

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