Back to resultsEffectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
Primary Purpose
Obstructive Sleep Apnea, Central Sleep Apnea (Diagnosis), Chronic Opioid Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive servo-ventilation (ASV)
Bi-Level PAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleeping, opioid medications, positive airway pressure
Eligibility Criteria
Inclusion Criteria:
- At least 18 years old
- Taking opioid medications for at least 6 months. Opioid medications include but are not limited to: oxycodone, fentanyl, methadone, levorphanol, hydromorphone, and morphine
- Using bi-level PAP for at least 30 days
Exclusion Criteria:
- Primary heart or lung disease, for example: chronic obstructive pulmonary disease, pulmonary fibrosis, severe heart failure, uncorrected congenital heart disease, pulmonary hypertension
- Primary neurologic disease, for example: neuromuscular disease, previous stroke or cognitive impairment
- Narcolepsy
- Acute upper respiratory tract infection
- Pregnant
Sites / Locations
- Stanford Center for Human Sleep Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Adaptive Servo-Ventilation (ASV) then BiLevel PAP
Bi-Level PAP then Adaptive Servo-Ventilation (ASV)
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Patient Comfort
Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01462084
Brief Title
Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
Official Title
Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Central Sleep Apnea (Diagnosis), Chronic Opioid Use
Keywords
sleeping, opioid medications, positive airway pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptive Servo-Ventilation (ASV) then BiLevel PAP
Arm Type
Experimental
Arm Description
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.
Arm Title
Bi-Level PAP then Adaptive Servo-Ventilation (ASV)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Adaptive servo-ventilation (ASV)
Intervention Description
Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual.
Intervention Type
Device
Intervention Name(s)
Bi-Level PAP
Intervention Description
Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed.
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI)
Description
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).
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Patient Comfort
Description
Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied
Time Frame
Up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years old
Taking opioid medications for at least 6 months. Opioid medications include but are not limited to: oxycodone, fentanyl, methadone, levorphanol, hydromorphone, and morphine
Using bi-level PAP for at least 30 days
Exclusion Criteria:
Primary heart or lung disease, for example: chronic obstructive pulmonary disease, pulmonary fibrosis, severe heart failure, uncorrected congenital heart disease, pulmonary hypertension
Primary neurologic disease, for example: neuromuscular disease, previous stroke or cognitive impairment
Narcolepsy
Acute upper respiratory tract infection
Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Cao, DO
Organizational Affiliation
Stanford Center for Human Sleep Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Center for Human Sleep Research
City
Redwood City
State/Province
California
ZIP/Postal Code
94603
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share IPD with other researchers
Learn more about this trial
Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
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