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N/A N=74 Randomized Single-blind Treatment

Sleep Disordered Breathing and Chronic Pain

Sleep Apnea Syndromes

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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