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Sound Modulation for Critical Illness (SMART Trial)
N/A
Waitlist Available
Led By Brian K Gehlbach, MD
Research Sponsored by Brian Gehlbach
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects aged 18-99 years who are expected to receive care on an adult critical care unit for at least 24 hours
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.
Awards & highlights
SMART Trial Summary
This trial will test how well two different types of noise-reduction help ICU patients manage stress-related physiological parameters.
Who is the study for?
This trial is for adults aged 18-99 in critical care expected to stay at least 24 hours. It's not for those with significant hearing loss, drug overdose, substance abuse disorders, untreated sleep disorders, on vasopressors, unresponsive or delirious patients, or those with dementia or neurodegenerative diseases.Check my eligibility
What is being tested?
The study tests if sound masking and noise reduction can lower stress in ICU patients. Participants will experience modified sound environments to see if these changes improve their physiological responses related to stress.See study design
What are the potential side effects?
Since the interventions involve sound modulation rather than medication or invasive procedures, side effects are minimal but may include discomfort due to changes in usual noise levels.
SMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 99 years old and will be in intensive care for at least a day.
SMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at the time of icu discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at the time of icu discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nocturnal LF/HF ratio (a.u.)
Secondary outcome measures
Discharged home (%, versus discharge to another health care facility or died)
Hospital length of stay (days)
Hospital mortality (%)
+5 moreOther outcome measures
Intra-individual nocturnal LF/HF ratio (a.u.)
SMART Trial Design
3Treatment groups
Active Control
Group I: Usual CareActive Control1 Intervention
Usual care will be provided.
Group II: Sound maskingActive Control1 Intervention
Use of headphones and relaxing music. Sennheiser HD 280 pro headphones will be used for sound masking.
Group III: Sound reductionActive Control1 Intervention
Use of noise reduction headphones. Pro For Sho safety ear muffs with a noise reduction rate of 34dB will be used.
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Who is running the clinical trial?
Brian GehlbachLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Critical Illness
24 Patients Enrolled for Critical Illness
Brian K Gehlbach, MDPrincipal InvestigatorFaculty
3 Previous Clinical Trials
597 Total Patients Enrolled
3 Trials studying Critical Illness
597 Patients Enrolled for Critical Illness
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication to raise my blood pressure.I use hearing aids or have significant hearing loss.I have not been treated for any sleep disorders.You are not able to respond or are confused.You have been admitted for a drug overdose or have a known problem with abusing substances.You have been diagnosed with dementia, Parkinson's disease, or another brain disorder that gets worse over time.You have a pacemaker or have had a heart transplant.I am between 18 and 99 years old and will be in intensive care for at least a day.I am on a ventilator through a tube in my windpipe.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Sound masking
- Group 3: Sound reduction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age restriction for this research venture exceed 25 years?
"As per the stipulated requirements, individuals aged 18 and over but not exceeding 99 can take part in this trial."
Answered by AI
Are there vacancies within this experiment open to participants?
"Per the clinicaltrials.gov website, this experimental research is actively seeking participants; it initially debuted on December 1st 2016 and was most recently modified on November 8th 2022."
Answered by AI
Is participation in this medical trial open to volunteers?
"This medical study needs 120 subjects with delirium between 18 to 99 years old. To qualify, participants must receive 24 hours of care in an intensive adult care unit."
Answered by AI
What is the cap for participants in this clinical research?
"Affirmative. Information hosted on clinicaltrials.gov divulges that this clinical trial is presently recruiting for participants. This experiment, which was initially published on December 1st 2016, requires the enrollment of 120 patients from a single location."
Answered by AI
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