N/A
N=74
Sleep Disordered Breathing and Chronic Pain
Sleep Apnea Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT01457014 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Number of Sleep Related Events Per Hour — 38.8; 17.4; 4.5; 7.6 events/hour — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- servo ventilation auto (Device); Continuous positive airway pressure (Device); servo ventilation manual (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Sleep Related Events Per Hour |
38.8; 17.4; 4.5; 7.6; 16.1; 8.4 | <0.001 sig |
| SECONDARY Percent Oxygen Saturation |
92.9; 94.6; 94.6; 94.5; 79.9; 85.5 | 0.627 |
| SECONDARY Number of Arterial Oxygen Saturation Per Hour |
32.8; 15.1; 5.9; 9.5 | .161 |
Summary
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 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) 15
Data sourced from ClinicalTrials.gov (NCT01457014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.