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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:
Information provided by (Responsible Party):
Lene Krenk, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01383369
First received: June 23, 2011
Last updated: September 27, 2011
Last verified: September 2011
  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 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383369

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

No publications provided

Responsible Party: Lene Krenk, Doctor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01383369     History of Changes
Other Study ID Numbers: H-C-FSP-2010-050
Study First Received: June 23, 2011
Last Updated: September 27, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on November 23, 2014