Outcome and Treatment of Complex Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University of Manitoba.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01137214
First received: June 1, 2010
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

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.

Condition Intervention Phase
Sleep Apnea
Device: Non-invasive positive pressure ventilator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Outcome and Treatment of Complex Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Resolution of sleep apnea [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    As measured by the apnea-hyponea index


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    As measured by Epworth Sleepiness Scale and Sleep Apnea Quality of Life Index


Estimated Enrollment: 360
Study Start Date: June 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPAP
Continuous Positive Airway Pressure
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.
Active Comparator: Adaptive Servo-Ventilator
Non-invasive positive pressure ventilator that applies a constant expiratory pressure, as well as a variable inspiratory pressure.
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.

Detailed Description:

Patients with suspected obstructive sleep apnea (OSA) are studied overnight in a sleep laboratory, as part of their routine clinical management. If they are found to have OSA during the first half of the night, they are started on continuous positive airway pressure (CPAP) by nasal mask as part of their routine clinical management. A certain percentage of these patients (best estimate from the literature 15%) will develop central sleep apnea (CSA) during their treatment with CPAP.

Participants will be recruited from patients treated with Continuous Positive Airway Pressure (CPAP) for obstructive sleep apnea who develop central sleep apnea (CSA) on CPAP, and are willing to give informed consent .

Patients will be treated with the "best CPAP" pressure, as determined by the sleep physician reading their sleep study. This is defined as the minimum pressure associated with elimination of obstructive events. Patients will be treated with CPAP for 12 weeks. Following treatment, patients will be brought back for a second sleep study to be assessed on CPAP.

Those that demonstrate resolution of CSA on the sleep study will continue on CPAP for an additional 12 weeks. Those that demonstrate persistent CSA will be randomized to either "best CPAP" or Adaptive Servo-ventilation (ASV) therapy for an additional 12 weeks. ASV will be titrated during the second sleep study to determine optimal settings. Patients will be compared at the end of 12 and 24 weeks of treatment regarding response to therapy. This will be assessed by compliance with therapy (as monitored by a smart card within the positive pressure machine), improvement in sleepiness as measured by the Epworth Sleepiness Score, and change in quality of life as measured by the Sleep Apnea Quality of Life Index (SAQLI) a validated quality of life instrument specific to sleep apnea.

In addition, in those who demonstrated persistent central apneas after 12 weeks of CPAP therapy, and were randomized to CPAP or ASV, a third and final sleep study will be done to assess the residual apnea-hypopnea index (the number of respiratory events divided by the number of hours of sleep) on therapy. In those randomized to CPAP who have a persistent poor clinical response associated with an abnormal residual AHI after 24 weeks of treatment, a further 12 week trial of ASV will be undertaken to assess whether it offers any benefit.

In addition to assessing the effect of treatment, the original diagnostic polysomnogram of all patients with complex sleep apnea will be analyzed to determine if there are any polysomnographic features that could be utilized to predict complex sleep apnea before CPAP is applied, (for example: 1) evidence of mixed apneas; or 2) a component of central apneas in addition to the predominant pattern of OSA.)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with obstructive sleep apnea who develop central sleep apnea once treated with CPAP

Exclusion Criteria:

  • Inability to give informed consent, inability to tolerate positive pressure ventilation
  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: NCT01137214

Contacts
Contact: Stephen Corne, MD 204-788-8670

Locations
Canada, Manitoba
Miseracordia Sleep Disorders Centre
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Stephen Corne, University of Manitoba Department of Internal Medicine
ClinicalTrials.gov Identifier: NCT01137214     History of Changes
Other Study ID Numbers: B2010:026
Study First Received: June 1, 2010
Last Updated: October 13, 2010
Health Authority: Canada: University of Manitoba Research Ethics Board

Keywords provided by University of Manitoba:
complex sleep apnea

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
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