Clinical Trials Logo
  1. Home
  2. Obstructive Sleep Apnea
  3. NCT00785070
  4. Details
NCT00785070 Clinical Trial

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

Obstructive Sleep Apnea Clinical Trial

— PROSPECT  

Official title:
Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00785070
Other study ID # PROSPECT
Secondary ID
Status Completed
Phase Phase 4
First received November 4, 2008
Last updated February 5, 2009
Start date April 2008
Est. completion date February 2009

Study information
Verified date February 2009
Source Memorial Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date February 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Memorial Health System Colorado Springs Colorado

Sponsors (2)
Lead Sponsor Collaborator
Memorial Health System Nexan Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of objective sleep data to standardized sleep questionnaires Pre and Post Operative Yes
Secondary Compare Pre and Post Operative Objective sleep data Pre and post operative Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05857384 - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs Phase 1
Recruiting NCT04547543 - Follow-up of Apneic Patients by Visio-consultation N/A
Recruiting NCT05371509 - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study N/A
Completed NCT02515357 - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea N/A
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Active, not recruiting NCT03189173 - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea Phase 2
Completed NCT04084899 - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed NCT03032029 - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting NCT04028011 - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting NCT06047353 - Community Health Advocates for Motivating PAP Use in Our Neighborhoods. N/A
Completed NCT05253963 - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea N/A
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed NCT03589417 - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting NCT04335994 - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing N/A
Withdrawn NCT04063436 - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea N/A
Recruiting NCT05385302 - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting NCT04572269 - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting NCT06467682 - 12-week Tele-exercise Program in Patients With OSA N/A
Withdrawn NCT04011358 - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study N/A