Obstructive Sleep ApneaNCT01462084
Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
A study testing Adaptive servo-ventilation (ASV) and Bi-Level PAP in people with Obstructive Sleep Apnea and Central Sleep Apnea (Diagnosis), run by ResMed at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Central Sleep Apnea (Diagnosis), Chronic Opioid Use
- What is being tested?
- Adaptive servo-ventilation (ASV) and Bi-Level PAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Center for Human Sleep Research
Redwood City, California, 94603
About this study
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
Read the 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.
- Being tested
- Adaptive servo-ventilation (ASV), Bi-Level PAP
- Keywords
- sleeping, opioid medications, positive airway pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea, Central, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Bi-Level PAPDevice
Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Adaptive servo-ventilation (ASV); Device: Bi-Level PAP |
| 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. Receives: Device: Adaptive servo-ventilation (ASV); Device: Bi-Level PAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 1 month
Secondary outcomes (1)
Patient Comfort
Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Cao, DO, Principal investigator, Stanford Center for Human Sleep Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462084
- Sponsor's protocol ID
- MA-01-10
- Status last verified
- Apr 2017
- First submitted
- 26 Oct 2011
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
- ClinicalTrials.gov ID
- NCT01462084
- Acronym / sponsor ID
- MA-01-10
- Keywords
- sleeping, opioid medications, positive airway pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Servo-Ventilation (ASV) then BiLevel PAP | Experimental | Device: Adaptive servo-ventilation (ASV), Device: Bi-Level PAPAdaptive 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 | Device: Adaptive servo-ventilation (ASV), Device: Bi-Level PAPBi-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Adaptive Servo-Ventilation (ASV) then BiLevel PAP, Bi-Level PAP then Adaptive Servo-Ventilation (ASV) |
| Bi-Level PAPBi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed. | Device | Adaptive Servo-Ventilation (ASV) then BiLevel PAP, Bi-Level PAP then Adaptive Servo-Ventilation (ASV) |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: Up to 1 month
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).
1 secondary outcome
Patient Comfort
Time frame: Up to 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share IPD with other researchers
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Cao, DO principal investigator
Stanford Center for Human Sleep Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive servo-ventilation (ASV) and Bi-Level PAP in people with Obstructive Sleep Apnea and Central Sleep Apnea (Diagnosis), run by ResMed at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (AHI) (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.