Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03942393 |
| Other study ID # |
NP23332 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2016 |
| Est. completion date |
September 2017 |
Study information
| Verified date |
May 2019 |
| Source |
Università degli Studi di Brescia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
Description:
This is a prospective observational study conducted from April 2016 to October 2017 in the
general-neurologic ICU In a university-affiliated hospital serving a population of 1 million
habitant in the north-east of Italy. Patients were considered eligible if they were older
than 18 and remained in the ICU for at least 24 hours. Patients with anamnestic severe
dementia, severely decreased mental state defined as Richmond Agitation-Sedation Scale (RASS)
lower than -3, and language barrier were excluded. Patients coming from other hospitals were
excluded, because they might have been treated with long-lasting sleep or sedative drugs,
which could deeply modify sleep quality. Patients needing continuous infusion of sedative
drugs were also excluded since this could interfere with the interpretation of PSG data.
Finally, 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.
The study was conducted in accordance with the Declaration of Helsinki and was approved by
the local Ethics Committee of Brescia (NP 23332). Patients' informed consent was waived due
to the lack of definition of a legal representative of temporarily incapacitated adult
patients in the Italian legislation. The informed consent was obtained from the surviving
patients as soon as they regained their mental competency. Family members received detailed
information on the study scope and protocol. .
Sleep was monitored using a simplified PSG, Sleep Profiler (Advanced Brain Monitoring) with
the device placed by the nursing staff, from 10:00 pm to 7:00 am, for a minimum of one night
to a maximum of five consecutive nights . In case of occurrence of any of the exclusion
criteria, such as positioning of external ventricular drainage, the PSG monitoring was
interrupted. The authors collected data on age, sex, the Simplified Acute Physiology Score
(SAPS II) reason for ICU admission, length of ICU stay, and presence of delirium, assessed
three times daily using the Confusion Assessment Method for the Intensive Care Unit
(CAM-ICU). Any administration of drugs that could influence sleep were also recorded,
including benzodiazepine as anxiolytics, opioids, dexmedetomidine, zolpidem, and melatonin.
The Sleep Profiler consists of a band with three channels for EEG, one channel for the
electromyography of the masseter muscle (a touch proof connector with two electrodes), a
plethysmography for heart rate, a microphone to register both ICU noise and patient snoring,
and a 3D accelerometer to record head movements23. The registered parameters were then
analyzed by a software that identifies sleep stages and Cortical Arousals (CA), and a report
was generated for each night.
The authors analyzed the association of nocturnal noise, defined as the percentage of Total
Sleep Time (TST) during which noise exceeds 40 decibel (dB), with duration of Rapid Eye
Movement (REM )and Slow Wave Sleep (SWS) phases, expressed as a percentage of TST, and number
of CAs.
STATISTICAL ANALYSIS Characteristics of the study population were summarized as number
(percentage) for binary variables, and as mean (standard deviation, SD) or median
(interquartile range, IQR), as appropriate, for continuous variables.
The study outcomes were duration of the REM and SWS stages and number of CAs, all analyzed as
binary variables: REM: 0% or > 0% of the TST; SWS: ≤9% or > 9% of TST (threshold previously
used in the literature24,25); CAs: ≤43 or >43 CAs per hour (threshold corresponding to the
median value in our ICU, in the absence of information from the literature).
The association of noise with REM, SWS and CAs was analyzed using mixed-effect logistic
regression models for repeated measures (measurements over nights for each patient),
adjusting for SAPS II, age and sex as potential confounders. A sensitivity analysis were also
performed in which further adjustment for the administration of drugs influencing sleep were
added. Results are presented as odds ratio (OR) and 95% confidence interval (95% CI).
All statistical analyses were performed using STATA (Stata Corp, Texas, USA).
