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Sleep Disordered Breathing and Chronic Pain

CompletedNot applicableNCT01457014
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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

Study details

Official title
BiPAP Adaptive Servo-Ventilation (AutoSV) Therapy in Patients With Chronic Pain and Sleep Disordered Breathing (SDB)
Conditions
  • Sleep Apnea Syndromes
Interventions
  • Device: servo ventilation auto
  • Device: Continuous positive airway pressure
  • Device: servo ventilation manual
Sponsor
Philips Respironics
Start date
2011-09
Primary completion
2013-04
Sex
All
Age range
from 21 Years to 70 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
4

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 chr…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01457014