Postoperative Sleep Disturbances After Fast Track Hip & NCT01144130

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01144130
Other study ID #	H-2-2010-011
Secondary ID
Status	Completed
Phase	N/A
First received	June 14, 2010
Last updated	September 19, 2011
Start date	May 2010
Est. completion date	October 2010

Study information
Verified date	October 2010
Source	Rigshospitalet, Denmark
Contact	n/a
Is FDA regulated	No
Health authority	Denmark: The Danish National Committee on Biomedical Research Ethics
Study type	Observational

Clinical Trial 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.

Recruitment information / eligibility
Status	Completed
Enrollment	10
Est. completion date	October 2010
Est. primary completion date	September 2010
Accepts healthy volunteers	No
Gender	Both
Age group	60 Years and older
Eligibility	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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors *(2)*
Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Lundbeck Center for Fast-Track Hip and Knee Replacement

Country where clinical trial is conducted

Denmark,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Duration of REM sleep before and first postoperative night			No