Sleep Apnea SyndromesNCT01457014
Sleep Disordered Breathing and Chronic Pain
A study testing servo ventilation auto, Continuous positive airway pressure and servo ventilation manual in people with Sleep Apnea Syndromes, run by Philips Respironics at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- servo ventilation auto, Continuous positive airway pressure and servo ventilation manual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2011to Sep 2013
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ages 21-70.
- Able to provide written informed consent.
- Diagnosis of chronic non-malignant pain (pain present for ≥ 6 months).
- Stable regimen of opioids (oral, transdermal, and/or intravenous) for chronic pain for at least 4 weeks prior to study participation with a prescribed opioid dose equal to at least 100 milliequivalents of morphine per 24 hours (Appendix 1).
- Agreement to undergo an in-lab Diagnostic polysomnography (PSG) demonstrating an Apnea-Hypopnea Index (AHI) of at least 20 and Central Apnea Index (CAI) ≥ 10 events per hour of sleep OR at least 25% of Total Sleep Time (TST) below 90% Oxygen Saturation (SAO2) saturation and AHI ≥ 10
- Agreement to undergo 3 full-night, in-lab PSG's on positive airway pressure therapy.
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- Agreement to undergo breathalyzer testing prior to each PSG visit
- Ability to provide reliable documentation of opioid medications (ex. Pharmacy records) as treatment for chronic pain for the previous 30 days.
- Willingness to undergo urine drug screening.
Who cannot join
- Participation in other interventional, sleep or pharmaceutical related research studies within 30 days prior to giving consent.
- Workers with variable shift schedules.
- Previous treatment with positive airway pressure therapy within 90 days of providing consent.
- Participants with any conditions in which positive airway pressure is medically contraindicated (e.g. recent pneumothorax, systolic BP < 80 mmHg).
- BMI > 40
- Unwilling to wear PAP.
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- Any surgery involving the upper airway, eye, nose, sinuses or middle ear within the last 90 days.
- Major or poorly managed medical or psychiatric condition that would interfere with the demands of the study, to the use of positive airway pressure, or the ability to complete the study.
- Previous diagnosis of severe chronic obstructive pulmonary disease (COPD) with an forced expiratory volume at one second (FEV1) < 1 liter or less than 50% predicted
- Presence of elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 50mmHg) due to intrinsic lung disease, neuromuscular or musculoskeletal disorders.
- Participants currently prescribed 24 hour oxygen therapy (nocturnal O2 therapy for obstructive sleep apnea (OSA) treatment is allowed)
- Females who are pregnant or, if of child bearing potential, not currently using medically reliable birth control methods.
- Participants prescribed opioids for reasons other than the management of chronic, non-malignant pain.
- Failure of two consecutive breathalyzer tests from study PSG nights
- Periodic Limb Movements (PLM's) with arousals > 15
Trial locations and contacts
4 sites in 1 country.
United States4 sites
NeuroTrials Research Inc.
Atlanta, Georgia, 30342
Sleep D/O Center of Alabama
Birmingham, Alabama, 35213
Arkansas Center for Sleep Medicine
Little Rock, Arkansas, 72211
Clayton Sleep Institute
St Louis, Missouri, 63143
About this study
Official title: BiPAP Adaptive Servo-Ventilation (AutoSV) Therapy in Patients With Chronic Pain and Sleep Disordered Breathing (SDB)
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.
Read the detailed description
Purpose: Opioid treatment of non-malignant chronic pain can result in hypoxemia, hypercarbia, and central sleep apnea. The aim of this study was to determine the initial efficacy of auto servo-ventilation (ASV) and after 3 months of home use.
Methods: This prospective multicenter interventional study recruited chronic pain patients prescribed ≥100 morphine equivalents for at least 4 months.
Participants: Following full-night polysomnography (PSG) to confirm the presence of sleep-disordered breathing, patients were randomized to three additional full-night-attended PSGs with continuous positive airway pressure (CPAP), ASV, and servo-ventilation with an initial mandatory pressure support of 6 cm water (H2O) ASV manual Minimum Pressure Support (PSmin). Following the PSGs, patients were sent home with EncoreAnywhere and ASV with or without mandatory pressure support.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- servo ventilation auto, Continuous positive airway pressure, servo ventilation manual
- Keywords
- chronic pain, sleep disordered breathing, Opioids
- Medical subject headings
- Sleep Apnea Syndromes, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
servo ventilation autoDevice
Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
Continuous positive airway pressureDevice
Also called CPAP
continuous positive airway pressure
servo ventilation manualDevice
servo ventilation titrated in manual mode
| Study group | Role | What they receive |
|---|---|---|
| servo ventilation auto mode | Active comparator | Inspiratory and expiratory pressures automatically determined by the servo ventilation device. Receives: Device: servo ventilation auto; Device: Continuous positive airway pressure; Device: servo ventilation manual |
| Continuous positive airway pressure | Active comparator | Airway pressure delivered at a constant pressure level. Receives: Device: Continuous positive airway pressure; Device: servo ventilation manual |
| servo ventilation manual | Active comparator | Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference. Receives: Device: servo ventilation manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sleep Related Events Per Hour
The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.
Measured: four full night Polysomnography (PSG's)
Secondary outcomes (2)
Percent Oxygen Saturation
Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.
Measured: four full night Polysomnography (PSG's)
Number of Arterial Oxygen Saturation Per Hour
Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.
Measured: four full night Polysomnography (PSG's)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionSep 2013
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 Sleep Apnea SyndromesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Wylie, MD, Principal investigator, Arkansas Center of Sleep MedicineVernon Pegram, PhD, Principal investigator, Sleep D/O Center of AlabamaMark Muehlbach, PhD, Principal investigator, Clayton Sleep InstituteRussell Rosenberg, MD, Principal investigator, NeuroTrials Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457014
- Sponsor's protocol ID
- SDBPM-2011-01
- Status last verified
- Jan 2016
- First submitted
- 30 Sep 2011
- Last updated
- 19 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BiPAP Adaptive Servo-Ventilation (AutoSV) Therapy in Patients With Chronic Pain and Sleep Disordered Breathing (SDB)
- ClinicalTrials.gov ID
- NCT01457014
- Acronym / sponsor ID
- SDBPM-2011-01
- Conditions
- Sleep Apnea Syndromes
- Keywords
- chronic pain, sleep disordered breathing, Opioids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Oct 2011 (estimated)
- Results
- Posted 19 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.
Detailed description
Purpose: Opioid treatment of non-malignant chronic pain can result in hypoxemia, hypercarbia, and central sleep apnea. The aim of this study was to determine the initial efficacy of auto servo-ventilation (ASV) and after 3 months of home use.
Methods: This prospective multicenter interventional study recruited chronic pain patients prescribed ≥100 morphine equivalents for at least 4 months.
Participants: Following full-night polysomnography (PSG) to confirm the presence of sleep-disordered breathing, patients were randomized to three additional full-night-attended PSGs with continuous positive airway pressure (CPAP), ASV, and servo-ventilation with an initial mandatory pressure support of 6 cm water (H2O) ASV manual Minimum Pressure Support (PSmin). Following the PSGs, patients were sent home with EncoreAnywhere and ASV with or without mandatory pressure support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| servo ventilation auto mode | Active comparator | Device: servo ventilation auto, Device: Continuous positive airway pressure, Device: servo ventilation manualInspiratory and expiratory pressures automatically determined by the servo ventilation device. |
| Continuous positive airway pressure | Active comparator | Device: Continuous positive airway pressure, Device: servo ventilation manualAirway pressure delivered at a constant pressure level. |
| servo ventilation manual | Active comparator | Device: servo ventilation manualInspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females, ages 21-70.
- Able to provide written informed consent.
- Diagnosis of chronic non-malignant pain (pain present for ≥ 6 months).
- Stable regimen of opioids (oral, transdermal, and/or intravenous) for chronic pain for at least 4 weeks prior to study participation with a prescribed opioid dose equal to at least 100 milliequivalents of morphine per 24 hours (Appendix 1).
- Agreement to undergo an in-lab Diagnostic polysomnography (PSG) demonstrating an Apnea-Hypopnea Index (AHI) of at least 20 and Central Apnea Index (CAI) ≥ 10 events per hour of sleep OR at least 25% of Total Sleep Time (TST) below 90% Oxygen Saturation (SAO2) saturation and AHI ≥ 10
Key exclusion criteria (15 listed)
- Participation in other interventional, sleep or pharmaceutical related research studies within 30 days prior to giving consent.
- Workers with variable shift schedules.
- Previous treatment with positive airway pressure therapy within 90 days of providing consent.
- Participants with any conditions in which positive airway pressure is medically contraindicated (e.g. recent pneumothorax, systolic BP < 80 mmHg).
- BMI > 40
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 |
|---|---|---|
| servo ventilation autoExpiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow. | Device | servo ventilation auto mode |
| Continuous positive airway pressureAlso: CPAPcontinuous positive airway pressure | Device | Continuous positive airway pressure, servo ventilation auto mode |
| servo ventilation manualservo ventilation titrated in manual mode | Device | Continuous positive airway pressure, servo ventilation auto mode, servo ventilation manual |
Primary outcome
Number of Sleep Related Events Per Hour
Time frame: four full night Polysomnography (PSG's)
The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.
2 secondary outcomes
Percent Oxygen Saturation
Time frame: four full night Polysomnography (PSG's)
Number of Arterial Oxygen Saturation Per Hour
Time frame: four full night Polysomnography (PSG's)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Wylie, MD principal investigator
Arkansas Center of Sleep Medicine
Vernon Pegram, PhD principal investigator
Sleep D/O Center of Alabama
Mark Muehlbach, PhD principal investigator
Clayton Sleep Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing servo ventilation auto, Continuous positive airway pressure and servo ventilation manual in people with Sleep Apnea Syndromes, run by Philips Respironics at 4 sites 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 9 inclusion and 15 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 19 Feb 2016). 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?
Number of Sleep Related Events Per Hour (time frame: four full night Polysomnography (PSG's)). 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 19 Feb 2016.