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Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the chronic use of opioid medications
The trial seeks to determine the efficacy and patient comfort of ASV and bi-level positive airway pressure (PAP) modes for the treatment of obstructive sleep apnea (OSA), complicated by CSA secondary to opioid use. Subjects will be randomized to one of two groups, utilizing a cross-over design to evaluate the two modes with the subject as their own control.
Subjects will be asked to undergo two PSG studies; one with ASV titration and one with bi-level treatment, using the current pressure prescription. The study comprises two visits. Subjects will be asked to complete patient satisfaction questionnaires following their PSG studies. It is anticipated that total subject participation will be no longer than one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Servo-Ventilation (ASV) then BiLevel PAP | Experimental | Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups. |
|
| Bi-Level PAP then Adaptive Servo-Ventilation (ASV) | Experimental | Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive servo-ventilation (ASV) | Device | Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea Hypopnea Index (AHI) | Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV). | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Comfort | Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied | Up to 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Cao, DO | Stanford Center for Human Sleep Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Center for Human Sleep Research | Redwood City | California | 94603 | United States |
There is no plan to share IPD with other researchers
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All patients were recruited from a single sleep center in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adaptive Servo-ventilation (ASV) | Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so patients in this arm used ASV therapy the first night and then crossed over and used BiLevel PAP the second night. |
| FG001 | Bi-Level PAP | Bi-level PAP delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so patients in this arm used Bi-Level PAP therapy the first night and then crossed over and used ASV the second night. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 60 patients were screened, 21 met the inclusion criteria, 1 dropped out, 2 patients were not titrated according to protocol and were excluded, leaving data from 18 patients available for inclusion in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All study patients included in final analysis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Apnea Hypopnea Index (AHI) | Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV). | Posted | Mean | Standard Deviation | events/hour | Up to 1 month |
|
Full study duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adaptive Servo-Ventilation (ASV) | Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Cao, DO, FAASM | Stanford Sleep Medicine | (650) 723-6601 | michellecao2007@gmail.com |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D020182 | Sleep Apnea, Central |
| D004194 | Disease |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Bi-Level PAP | Device | Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Bi-Level PAP |
Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups. |
|
|
| Secondary | Patient Comfort | Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied | Posted | Mean | Standard Deviation | units on a scale | Up to 1 month |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Bi-Level PAP | Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups. | 0 | 21 | 0 | 21 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |