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Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01383369
First Posted: June 28, 2011
Last Update Posted: September 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark
  Purpose
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.

Condition
Postoperative Cognitive Abilities

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Lene Krenk, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Stroop colour word test result on the first postoperative morning compared to preoperatively. [ Time Frame: 4 days on average between preoperative and postoeperative testing ]

Estimated Enrollment: 20
Study Start Date: February 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients above 60 years undergoing hip/knee replacement surgery in a fest track set-up.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383369


Locations
Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Lene Krenk, MD Rigshospitalet, Denmark
  More Information

Responsible Party: Lene Krenk, Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01383369     History of Changes
Other Study ID Numbers: H-C-FSP-2010-050
First Submitted: June 23, 2011
First Posted: June 28, 2011
Last Update Posted: September 28, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Dyssomnias
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms