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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03480789
• Other study ID #: sleep in ICU
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2018
• Last updated: March 26, 2018
• Start date: February 5, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2018
• Source: Chinese Medical Association
• Contact: Wenkui Yu, Ph.D
• Phone: 02568182222
• Email: yudrnj[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Problems
• Sleep

Intervention

Drug:
• Dexmedetomidine
given dexmedetomidine to meet RASS -1 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

Locations

Country	Name	City	State
China	The Affliated Drum Tower Hospital, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the total time of sleep	using EEG records the time of sleep and different sleep phases	the first 24hours in the icu