the Influence of Sleep Improvement Through Different Meth... | NCT03480789

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

NCT03480789

Sponsor

Chinese Medical Association

Status

Unknown status

Last Update Posted

Mar 29, 2018Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Metabolic Problems
Sleep

Interventions

Dexmedetomidine
eye patch

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 5, 2018Actual

Primary Completion Date

Jun 30, 2018Estimated

Completion Date

Jul 31, 2018Estimated

First Submitted Date

Mar 18, 2018

First Submission Date that Met QC Criteria

Mar 26, 2018

First Posted Date

Mar 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2018

Last Update Posted Date

Mar 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
eye patch	Experimental	wearing the eye patch from 22:00 to 6:00 of the next day	Device: eye patch
Dexmedetomidine	Experimental	given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day	Drug: Dexmedetomidine
eye patch + DEX	Experimental	given dexmedetomidine to meet RASS -1 and wearing the eye patch from 22:00 to 6:00 of the next day	Drug: Dexmedetomidine Device: eye patch
usual treatment	No Intervention	treatment as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day	Dexmedetomidine eye patch + DEX

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wenkui Yu, Ph.D	Contact	02568182222	60506	yudrnj@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Affliated Drum Tower Hospital, Medical School of Nanjing University	Recruiting	Nanjing	Jiangsu	210008	China

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided