NCT01144130

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

September 20, 2011

Status Verified

October 1, 2010

Enrollment Period

4 months

First QC Date

June 14, 2010

Last Update Submit

September 19, 2011

Conditions

REM Sleep Measurement

Outcome Measures

Primary Outcomes (1)

  • Duration of REM sleep before and first postoperative night

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients above 60 years undergoing hip/knee replacement surgery in a fest track set-up.

You may qualify if:

  • above 60
  • ASA classification I-IV

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre Hospital

Hvidovre, Denmark

Location

Study Officials

  • Lene Krenk, Doctor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 15, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

September 20, 2011

Record last verified: 2010-10

Locations

DK(1)