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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00785070

Acronym

PROSPECT

Enrollment

100

Registered

2008-11-05

Start date

2008-04-30

Completion date

2009-02-28

Last updated

2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Perioperative, Obstructive Sleep Apnea, Screening, Home Sleep Testing

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results