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Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04928157
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : November 23, 2021
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeremy Orr, M.D., University of California, San Diego

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sleep Disorder; Breathing-Related Pain Sleep Apnea Obstructive Sleep Apnea Sleep Sleep Disorder Chronic Pain Opioid Use Device: Positive Airway Pressure (PAP) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Arm Intervention/treatment
Experimental: CPAP
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.
Device: Positive Airway Pressure (PAP)
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.
Other Name: CPAP

No Intervention: Control
No CPAP use, otherwise usual care

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Brief pain inventory [ Time Frame: 8 weeks ]
    Pain questionnaire

Other Outcome Measures:
  1. Pain 11 point Likert scale [ Time Frame: 8 weeks ]
    Subjects will be asked to rank their "current pain level" on a scale of 0-10, where 0 is no pain and 10 is the worst possible pain.

  2. Insomnia Severity Index (ISI) [ Time Frame: 8 weeks ]
    A 7-item self-report form to assess insomnia severity. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).

  3. PROMIS Sleep-Related Impairment (SRI) [ Time Frame: 8 weeks ]
    Self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness.

  4. Epworth Sleepiness Scale (ESS) [ Time Frame: 8 weeks ]
    A self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.

  5. Current Opioid Misuse Measure (COMM) [ Time Frame: 8 weeks ]
    A brief patient self-assessment to monitor chronic pain patients on opioid therapy.

  6. Pittsburg Sleep Quality Index (PSQI) [ Time Frame: 8 weeks ]
    A 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

  7. Neuropathic pain scale short form [ Time Frame: 8 weeks ]
    A brief patient self-assessment to measure neuropathic pain symptoms, as well as assisting in discrimination between neuropathic and non-neuropathic pain.

  8. Beck Depression Inventory [ Time Frame: 8 weeks ]
    he questionnaire assesses mental health (i.e. depression). Each of the 21 items are given weighted values corresponding to a symptom of depression and summed to give a single score. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

  9. Psychomotor Vigilance (PVT) [ Time Frame: 8 weeks ]
    A 10-minutes, computerized reaction test asking subject to press a button every time a prompt appears. Faster times indicate better reactions and higher alertness.

  10. Apnea Hypopnea Index [ Time Frame: 8 weeks ]
    The number of times a person stops breathing and periods of shallow breathing with a marked decrease in blood oxygen concentration every hour on average. A score lower than five indicates normal sleep (no sleep apnea), 5-15 indicates mild sleep apnea, 15-30 indicates moderate sleep apnea, and a score greater than 30 indicates severe sleep apnea.

  11. Cold Pressor Test [ Time Frame: 8 weeks ]
    The cold pressor test will be performed to assess pain threshold and tolerance. Participants will immerse their hand into a cold water bath, and will be instructed to report the first painful sensation after immersion. They will then be asked to tolerate the stimulus as long as possible, but will be permitted to withdraw their hand from the cold water at any point. Maximum immersion time will be 5 mins. Latency to first feel pain (pain sensitivity) and latency to withdraw the hand from the water (pain tolerance) will be recorded. Blood pressure and heart rate will be measured before and after each immersion using the arm that was not immersed in the water bath.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04928157

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Contact: Pamela DeYoung 8582462183

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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92037
Contact: Pamela N DeYoung, RPSGT    858-246-2183   
Sponsors and Collaborators
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Jeremy Orr, MD University of California, San Diego
Additional Information:
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Responsible Party: Jeremy Orr, M.D., Assistant Clinical Professor, University of California, San Diego Identifier: NCT04928157    
Other Study ID Numbers: 201743
K23HL151880 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will be shared with other qualified investigators with local IRB approval
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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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
Keywords provided by Jeremy Orr, M.D., University of California, San Diego:
sleep apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Wake Disorders
Chronic Pain
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Nervous System Diseases
Neurologic Manifestations
Mental Disorders