- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01383369
Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty
September 27, 2011 updated by: Lene Krenk, Rigshospitalet, Denmark
The purpose of this study is to evaluate sleep cycle before and after fast-track arthroplasty (3 days before and 10 days after) combined with cognitive testing preoperatively, on postoperative day 1,2,10.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hellerup, Denmark, 2900
- Gentofte Hospital
-
-
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients above 60 years undergoing hip/knee replacement surgery in a fest track set-up.
Description
Inclusion Criteria:
- above 60
- ASA classification I-IV
Exclusion Criteria:
- general anaesthesia within 90 days
- daily use of sedatives, hypnotics og anxiolytics
- alcohol abuse
- insufficient written and verbal Danish
- severe hearing loss and poor sight
- Parkinsons Disease or other functional neurological deficits
- Mini mental status < 24
- Shift work
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Stroop colour word test result on the first postoperative morning compared to preoperatively.
Time Frame: 4 days on average between preoperative and postoeperative testing
|
4 days on average between preoperative and postoeperative testing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
June 23, 2011
First Submitted That Met QC Criteria
June 27, 2011
First Posted (Estimate)
June 28, 2011
Study Record Updates
Last Update Posted (Estimate)
September 28, 2011
Last Update Submitted That Met QC Criteria
September 27, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-C-FSP-2010-050
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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