Sleep Disorder; Breathing-RelatedPhase 2PRESTONCT04928157
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
A Phase 2 study testing Positive Airway Pressure (PAP) in people with Sleep Disorder; Breathing-Related and Pain, run by University of California, San Diego at 1 site in United States.
Trial summary
Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder; Breathing-Related, Pain, Sleep Apnea
- What is being tested?
- Positive Airway Pressure (PAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2021to 12 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18+
- Chronic pain
- Chronic opioid use (daily use for >3 months duration)
- Apnea-hypopnea index >/= 5 events/hr (screening sleep study will be performed)
Who cannot join
- Already using CPAP or non-invasive ventilation on a daily basis
- Use of opioids outside medical supervision (i.e. recreational use)
- Pain due to active cancer
- Prisoners
- Pregnancy
- Psychiatric illness other than treated mood disorders
Show all 9Show fewer
- Life expectancy <12 months
- Anticipated inability to sleep in the laboratory setting or to use CPAP
- Unable or unwilling to provide informed consent or comply with research procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92037
About this study
Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. The goal of this study is to determine whether patients with chronic pain who use opioids and have SDB might benefit from the use of CPAP in terms of sleep quality, pain, quality of life, and other measures. In addition, the study will examine whether these individuals are able to adhere to CPAP, which will be important for future studies. Lastly, we anticipate that CPAP won't work for everyone due to the changes that opioids can cause in breathing patterns. We will examine how often CPAP is ineffective, and whether we can predict which individuals are least likely to resolve their SDB with CPAP.
Read the detailed description
Patients who use chronic opioids for chronic pain daily for >3 months will be recruited. Patients with recently diagnosed sleep disordered breathing (SDB; defined as an apnea-hypopnea index >/=5 events/hr) will be studied, but a screening sleep study can be performed if the participant has not had a sleep study, and they will be included if SDB is found. Persons who are already under treatment for SDB with continuous positive airway pressure (CPAP) will be excluded, along with those with, recreational opioid use, cancer pain, limited life expectancy, prisoners, pregnant women, psychiatric disease, and those unable to provide consent or cooperate with research procedures. Potential subjects will discuss the planned research protocol, risks, benefits, and alternatives with the study staff.
Once the individual has given written informed consent, they will be scheduled for a baseline study visit, which will begin in the early evening. Subjects will undergo a comprehensive history and physical exam, questionnaires examining sleep quality, daytime function, pain, and quality of life. The cold pressor test will be administered, which includes submerging the non-dominant hand in a 4 degree Celsius water bath, and reporting the onset of pain and maximal tolerable submersion time.
After these procedures, the subject will be instrumented for an overnight sleep study, which will include the application of electrodes to the scalp (electroencephalogram), beside the eyes (electro-oculogram), chin and legs (electromyogram). Elastic bands will be applied around the chest and abdomen, a pulse oximeter will be affixed to the finger, and airflow monitors placed just inside the nose and outside the mouth. The subject will then be allowed to sleep until the morning. Upon awakening, they will undergo a computer test of alertness.
The subject will then be randomized to two groups. One group will be randomized to active CPAP treatment, for which they will be fitted with a nasal mask and instructed on the use of a commercial self-titrating CPAP machine. They will wear the device each night for the next 8 weeks. Use of the device will be monitored by the study staff, and the subject will be contacted by telephone on a weekly basis to address any issues. The other group will be randomized to usual care, which does not include CPAP treatment during this 8 week time interval.
After 8 weeks, subjects will return to the laboratory and undergo the same testing as the baseline visit. For the sleep study, those in the CPAP group will wear their CPAP device during the recording, while the other group will be tested without CPAP.
- Conditions
- Sleep Disorder; Breathing-Related, Pain, Sleep Apnea, Obstructive Sleep Apnea, Sleep, Sleep Disorder
- Being tested
- Positive Airway Pressure (PAP)
- Keywords
- sleep, sleep apnea, OSA
- Medical subject headings
- Sleep Wake Disorders, Pain, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure (PAP)Device
Also called CPAP
A device used with a nose or face mask which delivers airflow/pressure into the airway, holding the airway open and keeping it from collapsing. Device will be used for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | Use of CPAP, a device used with a nose or face mask which delivers airflow/pressure into the airway, holding the airway open and keeping it from collapsing. Device will be used for 8 weeks. Receives: Device: Positive Airway Pressure (PAP) |
| Control | No intervention | No CPAP use, otherwise usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS sleep disturbance
A questionnaire to assess self-reported quality of general sleep and sleep disturbance. Each item on the form is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Measured: 8 weeks
Secondary outcomes (1)
Brief pain inventory
Pain questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start10 Aug 2021
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorder; Breathing-RelatedStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeremy Orr, M.D., University of California, San Diego
- Investigators
- Jeremy Orr, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928157
- Sponsor's protocol ID
- 201743
- Other IDs
- K23HL151880
- Acronym
- PRESTO
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2021
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will be shared with other qualified investigators with local IRB approval
Publications
Orr JE, Bosompra NO, Norby B, Velazquez J, Khalaf A, DeYoung P, Schmickl CN, Sands SA, Jain S, He F, Goodin B, Wallace M, Owens RL, Malhotra A. Chronic pain is associated with sleep apnea severity but attenuated by intermittent hypoxemia in people using opioids. Pain. 2026 Jan 1;167(1):159-167. doi: 10.1097/j.pain.0000000000003760. Epub 2025 Jul 24.
PubMed 40705710
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
- ClinicalTrials.gov ID
- NCT04928157
- Acronym / sponsor ID
- PRESTO / 201743
- Conditions
- Sleep Disorder; Breathing-Related, Pain, Sleep Apnea, Obstructive Sleep Apnea, Sleep, Sleep Disorder
- Keywords
- sleep, sleep apnea, OSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. The goal of this study is to determine whether patients with chronic pain who use opioids and have SDB might benefit from the use of CPAP in terms of sleep quality, pain, quality of life, and other measures. In addition, the study will examine whether these individuals are able to adhere to CPAP, which will be important for future studies. Lastly, we anticipate that CPAP won't work for everyone due to the changes that opioids can cause in breathing patterns. We will examine how often CPAP is ineffective, and whether we can predict which individuals are least likely to resolve their SDB with CPAP.
Detailed description
Patients who use chronic opioids for chronic pain daily for >3 months will be recruited. Patients with recently diagnosed sleep disordered breathing (SDB; defined as an apnea-hypopnea index >/=5 events/hr) will be studied, but a screening sleep study can be performed if the participant has not had a sleep study, and they will be included if SDB is found. Persons who are already under treatment for SDB with continuous positive airway pressure (CPAP) will be excluded, along with those with, recreational opioid use, cancer pain, limited life expectancy, prisoners, pregnant women, psychiatric disease, and those unable to provide consent or cooperate with research procedures. Potential subjects will discuss the planned research protocol, risks, benefits, and alternatives with the study staff.
Once the individual has given written informed consent, they will be scheduled for a baseline study visit, which will begin in the early evening. Subjects will undergo a comprehensive history and physical exam, questionnaires examining sleep quality, daytime function, pain, and quality of life. The cold pressor test will be administered, which includes submerging the non-dominant hand in a 4 degree Celsius water bath, and reporting the onset of pain and maximal tolerable submersion time.
After these procedures, the subject will be instrumented for an overnight sleep study, which will include the application of electrodes to the scalp (electroencephalogram), beside the eyes (electro-oculogram), chin and legs (electromyogram). Elastic bands will be applied around the chest and abdomen, a pulse oximeter will be affixed to the finger, and airflow monitors placed just inside the nose and outside the mouth. The subject will then be allowed to sleep until the morning. Upon awakening, they will undergo a computer test of alertness.
The subject will then be randomized to two groups. One group will be randomized to active CPAP treatment, for which they will be fitted with a nasal mask and instructed on the use of a commercial self-titrating CPAP machine. They will wear the device each night for the next 8 weeks. Use of the device will be monitored by the study staff, and the subject will be contacted by telephone on a weekly basis to address any issues. The other group will be randomized to usual care, which does not include CPAP treatment during this 8 week time interval.
After 8 weeks, subjects will return to the laboratory and undergo the same testing as the baseline visit. For the sleep study, those in the CPAP group will wear their CPAP device during the recording, while the other group will be tested without CPAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: Positive Airway Pressure (PAP)Use of CPAP, a device used with a nose or face mask which delivers airflow/pressure into the airway, holding the airway open and keeping it from collapsing. Device will be used for 8 weeks. |
| Control | No intervention | –No CPAP use, otherwise usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18+
- Chronic pain
- Chronic opioid use (daily use for >3 months duration)
- Apnea-hypopnea index >/= 5 events/hr (screening sleep study will be performed)
Key exclusion criteria (9 listed)
- Already using CPAP or non-invasive ventilation on a daily basis
- Use of opioids outside medical supervision (i.e. recreational use)
- Pain due to active cancer
- Prisoners
- Pregnancy
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 |
|---|---|---|
| Positive Airway Pressure (PAP)Also: CPAPA device used with a nose or face mask which delivers airflow/pressure into the airway, holding the airway open and keeping it from collapsing. Device will be used for 8 weeks. | Device | CPAP |
Primary outcome
PROMIS sleep disturbance
Time frame: 8 weeks
A questionnaire to assess self-reported quality of general sleep and sleep disturbance. Each item on the form is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
1 secondary outcome
Brief pain inventory
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Derived from this study: PubMed 40705710Orr JE, Bosompra NO, Norby B, Velazquez J, Khalaf A, DeYoung P, Schmickl CN, Sands SA, Jain S, He F, Goodin B, Wallace M, Owens RL, Malhotra A. Chronic pain is associated with sleep apnea severity but attenuated by intermittent hypoxemia in people using opioids. Pain. 2026 Jan 1;167(1):159-167. doi: 10.1097/j.pain.0000000000003760. Epub 2025 Jul 24.
- UCSD Sleep Research WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Will be shared with other qualified investigators with local IRB approval
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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.
Jeremy Orr, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Positive Airway Pressure (PAP) in people with Sleep Disorder; Breathing-Related and Pain, run by University of California, San Diego 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 4 inclusion and 9 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 2 Dec 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PROMIS sleep disturbance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04928157, which also lists 1 linked publication.
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 2 Dec 2024.