Sleep Disordered Breathing and Chronic Pain

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: servo ventilation manual; Device: servo ventilation auto; Device: Continuous positive airway pressure

• Registration Number: NCT01457014
• Lead Sponsor: Philips Respironics

Brief Summary

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

Detailed Description

Purpose: Opioid treatment of non-malignant chronic pain can result in hypoxemia, hypercarbia, and central sleep apnea. The aim of this study was to determine the initial efficacy of auto servo-ventilation (ASV) and after 3 months of home use.

Methods: This prospective multicenter interventional study recruited chronic pain patients prescribed ≥100 morphine equivalents for at least 4 months.

Participants: Following full-night polysomnography (PSG) to confirm the presence of sleep-disordered breathing, patients were randomized to three additional full-night-attended PSGs with continuous positive airway pressure (CPAP), ASV, and servo-ventilation with an initial mandatory pressure support of 6 cm water (H2O) ASV manual Minimum Pressure Support (PSmin). Following the PSGs, patients were sent home with EncoreAnywhere and ASV with or without mandatory pressure support.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-30
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-21
• Primary Completion: 2013-04
• Study Completion: 2013-09
• Results First Submitted: 2015-10-29
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-22
• Last Update Submitted: 2016-01-22
• Results First Posted: 2016-02-19
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 chronic, non-malignant pain.
14. Failure of two consecutive breathalyzer tests from study PSG nights
15. Periodic Limb Movements (PLM's) with arousals > 15

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
servo ventilation manual	servo ventilation manual	Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.
servo ventilation auto mode	servo ventilation auto	Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
Continuous positive airway pressure	Continuous positive airway pressure	Airway pressure delivered at a constant pressure level.
Continuous positive airway pressure	servo ventilation manual	Airway pressure delivered at a constant pressure level.
servo ventilation auto mode	Continuous positive airway pressure	Inspiratory and expiratory pressures automatically determined by the servo ventilation device.
servo ventilation auto mode	servo ventilation manual	Inspiratory and expiratory pressures automatically determined by the servo ventilation device.

Primary Outcome Measures

Name	Time	Method
Number of Sleep Related Events Per Hour	four full night Polysomnography (PSG's)	The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.

Secondary Outcome Measures

Name	Time	Method
Percent Oxygen Saturation	four full night Polysomnography (PSG's)	Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.
Number of Arterial Oxygen Saturation Per Hour	four full night Polysomnography (PSG's)	Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.

Trial Locations

Locations (4)

Sleep D/O Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

NeuroTrials Research Inc.; 🇺🇸 Atlanta, Georgia, United States

Clayton Sleep Institute; 🇺🇸 St. Louis, Missouri, United States

Arkansas Center for Sleep Medicine; 🇺🇸 Little Rock, Arkansas, United States