Outcome and Treatment of Complex Sleep Apnea

NCT ID: NCT01137214

Last Updated: 2015-02-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-09-30

Brief 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.

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.)

Conditions

Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CPAP

Continuous Positive Airway Pressure

Group Type: ACTIVE_COMPARATOR

Non-invasive positive pressure ventilator

Intervention Type: DEVICE

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.

Adaptive Servo-Ventilator

Non-invasive positive pressure ventilator that applies a constant expiratory pressure, as well as a variable inspiratory pressure.

Group Type: ACTIVE_COMPARATOR

Non-invasive positive pressure ventilator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

University of Manitoba Department of Internal Medicine

Locations

Miseracordia Sleep Disorders Centre

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2010:026

Identifier Type: -

Identifier Source: org_study_id