Sleep Disordered Breathing and Chronic Pain

Completed · Not applicable

Conditions studied: Sleep Apnea Syndromes

In brief

The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.

Key facts

Study ID

NCT01457014

Run by

Philips Respironics

People needed

88

Starts

2011-09-01

Expected to finish

2013-09-01

Last updated by the study team

2016-02-19

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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

Where it is running

• NeuroTrials Research Inc. — Atlanta, Georgia, United States
• Clayton Sleep Institute — St Louis, Missouri, United States
• Sleep D/O Center of Alabama — Birmingham, Alabama, United States
• Arkansas Center for Sleep Medicine — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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