NCT03942393

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

May 4, 2019

Last Update Submit

May 7, 2019

Conditions

Sleep Phase Rhythm Disturbance

Keywords

noisesleep qualitypolysomnographycortical arousalsREM sleepIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Number of cortical arousals per hour

    analyzed as binary variables:\< 43 or \> 43per hour regression

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

Secondary Outcomes (2)

  • presence of REM phases

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

  • Duration of SWS phases

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All critically Ill patients recovered in intensive care unit non comatose whith a waking sleep rhythm

You may qualify if:

  • older than 18
  • recovered in ICU
  • remained in the ICU for at least 24 hours.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spedali Civili, Anestesia e Rianimazione 2

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • ELISA SEGHELINI

    II Servizio Rianimazione,, Spedali Civili Brescia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2019

First Posted

May 8, 2019

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)