Postoperative Sleep Disturbances Role in Cognitive Test R... | NCT01383369

Studies
Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

NCT01383369

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Sep 28, 2011Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Postoperative Cognitive Abilities

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

Sep 2011

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

Feb 2011

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jun 23, 2011

First Submission Date that Met QC Criteria

Jun 27, 2011

First Posted Date

Jun 28, 2011Estimated

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 27, 2011

Last Update Posted Date

Sep 28, 2011Estimated

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 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.

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

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroop colour word test result on the first postoperative morning compared to preoperatively.		4 days on average between preoperative and postoeperative testing

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, 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

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, MD	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gentofte Hospital		Hellerup		2900	Denmark