Sleep Disordered Breathing and Chronic Pain
Sleep Disordered Breathing and Chronic Pain
The purpose of this study is to evaluate positive pressure in patients with chronic pain
 taking opioid medications who have sleep disordered breathing.
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.
Inclusion Criteria:

 1. Males and females, ages 21-70.

 2. Able to provide written informed consent.

 3. Diagnosis of chronic non-malignant pain (pain present for ≥ 6 months).

 4. 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).

 5. 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

 6. Agreement to undergo 3 full-night, in-lab PSG's on positive airway pressure therapy.

 7. Agreement to undergo breathalyzer testing prior to each PSG visit

 8. Ability to provide reliable documentation of opioid medications (ex. Pharmacy records)
 as treatment for chronic pain for the previous 30 days.

 9. Willingness to undergo urine drug screening.

 Exclusion Criteria:

 1. Participation in other interventional, sleep or pharmaceutical related research
 studies within 30 days prior to giving consent.

 2. Workers with variable shift schedules.

 3. Previous treatment with positive airway pressure therapy within 90 days of providing
 consent.

 4. Participants with any conditions in which positive airway pressure is medically
 contraindicated (e.g. recent pneumothorax, systolic BP < 80 mmHg).

 5. BMI > 40

 6. Unwilling to wear PAP.

 7. Any surgery involving the upper airway, eye, nose, sinuses or middle ear within the
 last 90 days.

 8. 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.

 9. 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

 10. Presence of elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 50mmHg) due
 to intrinsic lung disease, neuromuscular or musculoskeletal disorders.

 11. Participants currently prescribed 24 hour oxygen therapy (nocturnal O2 therapy for
 obstructive sleep apnea (OSA) treatment is allowed)

 12. Females who are pregnant or, if of child bearing potential, not currently using
 medically reliable birth control methods.

 13. Participants prescribed opioids for reasons other than the management of chronic,
 non-malignant pain.

 14. Failure of two consecutive breathalyzer tests from study PSG nights

 15. Periodic Limb Movements (PLM's) with arousals > 15