Pre and Post Orthopedic Surgery Sleep and Cardiac Testing... | NCT00785070

Studies
Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)

NCT00785070

Sponsor

Memorial Health System

Status

Completed

Last Update Posted

Feb 9, 2009Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

Not provided

Countries

United States

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

Feb 2009

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

Apr 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Nov 4, 2008

First Submission Date that Met QC Criteria

Nov 4, 2008

First Posted Date

Nov 5, 2008Estimated

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

Feb 5, 2009

Last Update Posted Date

Feb 9, 2009Estimated

Name	Class
Nexan Inc	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System)
Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep study device results.
Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical population.

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

100Estimated

Label	Type	Description	Intervention Names
1		Perioperative

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of objective sleep data to standardized sleep questionnaires		Pre and Post Operative

Secondary Outcomes

Measure	Description	Time Frame
Compare Pre and Post Operative Objective sleep data		Pre and post operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Undergoing knee or hip total joint replacement
Answer Yes to any PROSPECT health history questions and/or score Positive on the sleep questionnaires

Exclusion Criteria:

Tape Allergy
Previous Diagnosis Of Obstructive Sleep Apnea

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Orthopedic Total Hip or Knee Joint Replacement

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clayton B. Carr, M.D.	Memorial Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Health System		Colorado Springs	Colorado	80909	United States

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided