Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Center for Fast-Track Hip and Knee Replacement
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01144130
First received: June 14, 2010
Last updated: September 19, 2011
Last verified: October 2010
  Purpose

The purpose of this study is to quantify the degree of sleep disturbances after hip or knee replacement surgery.

Through polysomnographic monitoring the disturbances in sleep stages will be clarified.


Condition
REM Sleep Measurement

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Duration of REM sleep before and first postoperative night [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: May 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (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
  • alcohol abuse
  • insufficient written and verbal Danish
  • severe hearing loss and poor sight
  • Parkinsons Disease or other functional neurological deficits
  • Mini mental status < 24
  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: NCT01144130

Locations
Denmark
Hvidovre Hospital
Hvidovre, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Lundbeck Center for Fast-Track Hip and Knee Replacement
Investigators
Principal Investigator: Lene Krenk, Doctor Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Lene Krenk, Doctor, Lundbeckcenter for fasttrack hip and knee replacement
ClinicalTrials.gov Identifier: NCT01144130     History of Changes
Other Study ID Numbers: H-2-2010-011
Study First Received: June 14, 2010
Last Updated: September 19, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on September 16, 2014