Home Diagnosis and Treatment of Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00139022
First received: August 26, 2005
Last updated: October 4, 2007
Last verified: February 2007
  Purpose

Obstructive Sleep Apnea (OSA) is a common and underrecognised condition. The diagnosis of OSA is typically made after an in-lab polysomnography (PSG) which requires an overnight stay in a sleep laboratory. Many sleep laboratories have long waiting lists for PSG. There are a number of portable devices which may be useful in home diagnosis of OSA, however there is limited data on outcomes of OSA diagnosed and treated at home. In this study we propose to compare diagnostic accuracy of a home monitoring device with a PSG and outcomes of OSA therapy when implemented at home vs in the sleep laboratory.


Condition Intervention
Obstructive Sleep Apnea
Device: Continuous Positive Airway Pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Can Obstructive Sleep Apnea be Diagnosed at Home? A Randomised Trial of Home vs.in-Lab Diagnosis and Treatment of OSA.

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Sleepiness score

Secondary Outcome Measures:
  • Quality of life
  • Vigilance tests
  • Sleep quality
  • CPAP compliance

Estimated Enrollment: 50
Study Start Date: November 2004
Study Completion Date: June 2007
Detailed Description:

We will randomise patients suspected to have OSA to either home evaluation and treatment (using a portable monitor and auto-CPAP) or in-lab evaluation with a PSG and manually-titrated CPAP. We will obtain sleep, sleepiness and quality of life questionnaires, vigilance testing and blood pressure at baseline and after 1, 2, 4 and 12 weeks of therapy. We will also assess and compare compliance with CPAP therapy in each arm of the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult ( age > 18)
  • suspected OSA
  • no coexisting heart or lung disease
  • not in a safety-sensitive occupation

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139022

Locations
Canada, Saskatchewan
Sleep Disorders Center, Royal Univerisity Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W0
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Robert P Skomro, MD Univerisity of Saskatchewan
  More Information

No publications provided by University of Saskatchewan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00139022     History of Changes
Other Study ID Numbers: BIO-REB# 04-91
Study First Received: August 26, 2005
Last Updated: October 4, 2007
Health Authority: Canada: Health Canada

Keywords provided by University of Saskatchewan:
sleep apnea, home monitoring, CPAP

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014