Postoperative Sleep Disturbances After Fast Track Hip and... | NCT01144130

Studies
Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement

NCT01144130

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Sep 20, 2011Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

REM Sleep Measurement

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 14, 2010

First Submission Date that Met QC Criteria

Jun 14, 2010

First Posted Date

Jun 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2011

Last Update Posted Date

Sep 20, 2011Estimated

Name	Class
Lundbeck Center for Fast-Track Hip and Knee Replacement	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of REM sleep before and first postoperative night

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lene Krenk, Doctor	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hvidovre Hospital		Hvidovre			Denmark