Treatment for Delirium

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Iowa Hospitals and Clinics, Iowa City, IA
Delirium+3 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether noise reduction and masking may help reduce stress in critically ill patients.

See full description

Eligible Conditions

  • Delirium
  • Stress, Physiological
  • Sleep Debt
  • Critical Illness

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome, 8 secondary outcomes, and 1 other outcome in patients with Delirium. Measurement will happen over the course of Day 1 of study.

Day 28
Incidence of ICU delirium
Day 28
ICU length of stay (days)
Day 28
Discharged home (%, versus discharge to another health care facility or died)
Hospital length of stay (days)
Hospital mortality (%)
Day 1 of study
Nocturnal LF/HF ratio (a.u.)
Nocturnal RMSSD (ms)
Nocturnal blood pressure (mm Hg)
Nocturnal heart rate (bpm)
Day 1
Intra-individual nocturnal LF/HF ratio (a.u.)

Trial Safety

Trial Design

3 Treatment Groups

Usual Care
1 of 3
Sound masking
1 of 3
Sound reduction
1 of 3
Active Control

This trial requires 120 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Usual CareUsual care will be provided.
Sound masking
Device
Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.
Sound reduction
Device
Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment. for reporting.

Closest Location

University of Iowa Hospitals and Clinics - Iowa City, IA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects aged 18-99 years who are expected to receive care on an adult critical care unit for at least 24 hours

Patient Q&A Section

What is sleep debt?

"Sleep debt describes the consequences of an imbalance of nighttime sleep and daytime wakefulness. The cumulative effect of sleep debt can lead to increased daytime fatigue, attentional and cognitive dysfunction, and sleep and mood disturbances." - Anonymous Online Contributor

Unverified Answer

Can sleep debt be cured?

"Sleep debt could be cured in most cases with a few exceptions. For example, some people may have a sleep debt that does not seem to affect their mood and sleep at the end of the month, while another person with a large sleep debt could experience mood swings if his sleep debt does not change." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleep debt?

"Sleep debt is commonly treated with medication, such as hypnotics or anticonvulsants. More rigorous treatment may involve sleep deprivation and/or sleep phase-advancing to sleep restriction. This article is protected by copyright. All rights reserved." - Anonymous Online Contributor

Unverified Answer

What causes sleep debt?

"The combination of excessive daytime sleep, impaired sleep quality or duration, and daytime napping all contribute to sleep debt. The duration of the sleep-wake cycle seems to be an important factor when considering sleep debt rather than sleep deficit." - Anonymous Online Contributor

Unverified Answer

What are the signs of sleep debt?

"Results from a recent clinical trial have direct implications on our understanding of sleep debt and will lead to improved ways to diagnose, treat and prevent sleep debt and insomnia." - Anonymous Online Contributor

Unverified Answer

How many people get sleep debt a year in the United States?

"Around 20 million Americans report they don't get enough sleep each year. It is important to examine the health consequences of sleep debt as an under-recognized health problem." - Anonymous Online Contributor

Unverified Answer

What is the latest research for sleep debt?

"The study was [researched in the Journal of the American Sleep Association]. After evaluating the study [through peer-review methodologies], we found some results that were inconsistent with the previous studies. It was the first time, for an extended study, we had to test multiple statistical analysis methods. When we tested the statistical analysis techniques [with SPSS], we were only able to find two groups of experiments that had a significant difference. In all the experiments involving a group, only one of them had a significant difference. We were also able to conclude that in a couple of experiments, we could not detect the difference, at all." - Anonymous Online Contributor

Unverified Answer

How serious can sleep debt be?

"Moderate sleep deprivation was associated with poorer executive function, but not with major depressive episodes nor poorer health. It can be concluded that sleep debt has a limited impact on mental health. Data from a recent study was based on the [NEURODNET-2] database, and other studies may reach different conclusions." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"Results from a recent clinical trial highlights the importance of considering the context surrounding treatment with a patient in terms of the social, psychological, and physical burden of their life." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets sleep debt?

"When sleep debt was analyzed using age, age 5 accounted for 38.8% of the sleep debt. This is not necessarily surprising, given that sleep debt affects teens very early while they are transitioning into adulthood. There was a small effect of age 7, which was probably an artifact of the age 9 data being from individuals who were very close to their age of sleep debt. From 9 to 11, 11.6% of the sleep debt was accounted for by age 11. Because sleep debt is likely to affect youth much later in life, as well as early childhood, this is likely to have a large effect on older generations as well." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating sleep debt?

"Since the introduction of the first benzodiazepine derivatives, there had been very few effective hypnotic medications for sleep debt. Because of the development of the [benzodiazepine hypothesis], scientists began to search for a medication which would be effective for sleep debt. Benzodiazepines were thought to inhibit REM sleep and therefore lead to a'recovery effect' which was shown to be wrong because in the 1950s [benzodiazepines were used for anxiety and pain. Therefore, benzodiazepine sleep-inducing effects in the human body were really a side effect. The benzodiazepines were not effective in treating sleep debt and they were even harmful for it. The benzodiazepine hypothesis is disproven." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with sleep debt?

"In a recent study, findings showed that the quality of life and sleep parameters improved in the study group in spite of the high sleep debt. Moreover, the high improvement in the parameters of QOL and sleep show the positive influence of the prescribed treatments on those with sleep debt who are suffering from insomnia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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