View Clinical Trial (Medical Research Study)
BiPAP AutoSV Therapy in Patients With Chronic Pain and SDB
| City: |
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Little Rock |
| State: |
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Arkansas |
| Zip Code: |
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72211 |
| Conditions: |
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Sleep Apnea Syndromes |
| Purpose: |
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The purpose of this study is to evaluate positive pressure in patients with chronic pain
taking opioid medications who have sleep disordered breathing.
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| Study Summary: |
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| Criteria: |
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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 AHI
of at least 20 and CAI ≥ 10 events per hour of sleep OR at least 25% of TST below 90%
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 COPD with an 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
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. PLM's with arousals > 15
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| NCT ID: |
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NCT01457014 |
| Primary Contact: |
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Principal Investigator
Paul Wylie, MD
Arkansas Center of Sleep Medicine
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| Backup Contact: |
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N/A |
| Location Contact: |
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Little Rock, Arkansas 72211
United States
Amy Kelley, BSN
Email: akelley1@windstream.net
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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