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Outcome and Treatment of Complex Sleep Apnea

NCT01137214 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-02-13

No results posted yet for this study

Summary

The purpose of the project is:

1. to determine the incidence of complex sleep apnea
2. to determine what percentage of cases will resolve over time with therapy with Continuous Positive Airway Pressure
3. Determine whether there is any difference in outcome, in those with persistent complex sleep apnea on CPAP, between those treated with CPAP or adaptive servo-ventilation.

Conditions

Interventions

DEVICE

Non-invasive positive pressure ventilator

All patients will initially be treated with CPAP for 12 weeks as part of usual clinical treatment for sleep apnea. A sleep study will be conducted after this and prior to randomization into the study. If this repeat sleep study demonstrates persistent central sleep apnea, patients will be randomized into 2 study groups. Group 1 - CPAP for 24 weeks. Group 2 - first 12 weeks CPAP (Continuous Positive Airway Pressure. Next 12 weeks - (ASV) Adaptive Servo ventilation. If the treatment is not working well at 12 weeks the participant/patients have the option of switching to the alternate treatment. Patients will be notified if they are to be switched to ASV. Participants will be asked to fill in the Epworth Sleepiness Score Questionnaire and Sleep Apnea Quality of Life Index form at 12 and 24 weeks.

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01137214 on ClinicalTrials.gov