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Behavioural Intervention

Sleep Hygiene for Delirium

N/A

Recruiting

Led By Farhaan Vahidy, PhD

Research Sponsored by Farhaan S. Vahidy

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non-critically ill patients (≥70 years)

Be older than 65 years old

Must not have

Patients with initial admission to intensive care unit including requirement for mechanical ventilation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce delirium in older adults in hospitals by improving their sleep environment. Researchers will use a sleep hygiene bundle that has been successful in reducing delirium in the past.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

Since this intervention focuses on non-medical changes like improving sleep conditions, side effects are minimal but could include discomfort due to changes in routine or environment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 70 years or older and not critically ill.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of admission to the date of discharge or death, whichever comes first, outcome will be assessed at every 12 hours (twice in a 24 hour time period), up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence to MMSH bundle components: Nighttime and Daytime

Delirium Burden Index (DBI) among patients with either delirium present on admission or those who develop HAD

Factors facilitating or impeding implementation of MMSH bundle

+1 more

Secondary study objectives

Delirium Assessment Positivity Rate

Delirium free days

Duration of daytime sleeping via actigraphy (non Z-time sleeping)

+11 more

Other study objectives

Duration of nighttime (10:00 pm to 5:00 am - 'Z-time') sleep time

Frequency of nocturnal (10:00 pm to 5:00 am - 'Z-time') awakenings

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MMSH (Multi-Modal Sleep Hygiene) BundleExperimental Treatment1 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 CareActive Control1 Intervention

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

0 / 2Eligibility criteria met