CompletedNot Applicable

Noise in the Intensive Care Care Unit and Its Influence on Cortical Arousals and Sleep Phases

Italy40 participantsStarted 2016-04-01

Plain-language summary

This is a prospective observational study in an Italian general-neurologic ICU. Sleep was monitored during the night, using a simplified polysomnography(PSG), for a maximum of five consecutive nights. Adults patients were eligible for the study if they remained in the ICU for at least 24 hours

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * older than 18 * recovered in ICU * remained in the ICU for at least 24 hours. Exclusion Criteria: * patients with anamnestic severe dementia * patients with severely decreased mental state (defined as Richmond Agitation-Sedation Scale, RASS, lower than -3) * presence of language barrier * patients coming from other hospitals * patients needing continuous infusion of sedative drugs * patients with frontal wounds, brain lesions in the frontal lobes, external ventricular drainage and noninvasive mechanical ventilation were excluded because of the impossibility to position the PSG device

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of cortical arousals per hour

Timeframe: Up to 5 consecutive nights from 10:00 pm to 7:00 am

Trial details

NCT IDNCT03942393

SponsorUniversità degli Studi di Brescia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-09

View on ClinicalTrials.gov More Sleep Phase Rhythm Disturbance trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.