the Influence of Sleep Improvement Through Different Methods on Patients in ICU

March 26, 2018 updated by: Chinese Medical Association
In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the research, we enroll 120 postoperative patients in the ICU and they will be assigned to four group: the eye patch group, the Dexmedetomidine(DEX) group, the eye patch+DEX group and the usual group. The sleep quality would be evaluated by the EEG monitor and the metabolic level, the inflammation and nutrition status would be detected. The research aims to confirm that the sleep quality could have a great influence on patients in the ICU and different interventions would make various changes.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wenkui Yu, Ph.D
  • Phone Number: 60506 02568182222
  • Email: yudrnj@163.com

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • The Affliated Drum Tower Hospital, Medical School of Nanjing University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the postoperative patients that admission to icu is more than 48h

Exclusion Criteria:

  • pregnant or breastfeeding
  • sleep disorders before operation
  • poor liver or kidney function
  • post craniocerebral operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eye patch
wearing the eye patch from 22:00 to 6:00 of the next day
Device: eye patch
wearing the eye patch from 22:00 to 6:00 of the next day
Other Names:
  • blinders
Experimental: Dexmedetomidine
given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day
Drug: Dexmedetomidine
given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day
Other Names:
  • Precedex
Experimental: eye patch + DEX
given dexmedetomidine to meet RASS -1 and wearing the eye patch from 22:00 to 6:00 of the next day
Device: eye patch
wearing the eye patch from 22:00 to 6:00 of the next day
Other Names:
  • blinders
Drug: Dexmedetomidine
given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day
Other Names:
  • Precedex
No Intervention: usual treatment
treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the total time of sleep
Time Frame: the first 24hours in the icu
using EEG records the time of sleep and different sleep phases
the first 24hours in the icu

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Medical Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2018

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

July 31, 2018

Study Registration Dates

First Submitted

March 18, 2018

First Submitted That Met QC Criteria

March 26, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sleep in ICU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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