Sleep Disordered Breathing and Chronic Pain

NCT01457014 | Completed Results

• 1 other identifier: SDBPM-2011-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

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.

Conditions

Sleep Apnea Syndromes

Keywords

chronic pain; sleep disordered breathing; Opioids

Outcome Measures

Primary Outcomes (1)

• Number of Sleep Related Events Per Hour

  The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.

  four full night Polysomnography (PSG's)

Secondary Outcomes (2)

• Percent Oxygen Saturation

  four full night Polysomnography (PSG's)

• Number of Arterial Oxygen Saturation Per Hour

  four full night Polysomnography (PSG's)

Study Arms (3)

servo ventilation auto mode

ACTIVE COMPARATOR

Inspiratory and expiratory pressures automatically determined by the servo ventilation device.

Device: servo ventilation auto; Device: Continuous positive airway pressure; Device: servo ventilation manual

Continuous positive airway pressure

ACTIVE COMPARATOR

Airway pressure delivered at a constant pressure level.

Device: Continuous positive airway pressure; Device: servo ventilation manual

servo ventilation manual

ACTIVE COMPARATOR

Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.

Device: servo ventilation manual

Interventions

servo ventilation auto DEVICE

Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.

servo ventilation auto mode

Continuous positive airway pressure DEVICE

continuous positive airway pressure

Also known as: CPAP

Continuous positive airway pressure; servo ventilation auto mode

servo ventilation manual DEVICE

servo ventilation titrated in manual mode

Continuous positive airway pressure; servo ventilation auto mode; servo ventilation manual

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \< 80 mmHg).
• BMI \> 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) \< 1 liter or less than 50% predicted
• Presence of elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 50mmHg) due to intrinsic lung disease, neuromuscular or musculoskeletal disorders.
• Participants currently prescribed 24 hour oxygen therapy (nocturnal O2 therapy for obstructive sleep apnea (OSA) treatment is allowed)
• Females who are pregnant or, if of child bearing potential, not currently using medically reliable birth control methods.
• Participants prescribed opioids for reasons other than the management of chronic, non-malignant pain.
• Failure of two consecutive breathalyzer tests from study PSG nights
• Periodic Limb Movements (PLM's) with arousals \> 15

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (4)

Sleep D/O Center of Alabama

Birmingham, Alabama, 35213, United States

Location

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, 72211, United States

Location

NeuroTrials Research Inc.

Atlanta, Georgia, 30342, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Chronic Pain

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Sharon A. Chung
• Organization: Sleep and Alertness Research Inc.

sachung@uhnres.utoronto.ca

416-603-5275

Study Officials

• Paul Wylie, MD

  Arkansas Center of Sleep Medicine

  PRINCIPAL INVESTIGATOR

• Vernon Pegram, PhD

  Sleep D/O Center of Alabama

  PRINCIPAL INVESTIGATOR

• Mark Muehlbach, PhD

  Clayton Sleep Institute

  PRINCIPAL INVESTIGATOR

• Russell Rosenberg, MD

  NeuroTrials Research, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 21, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 19, 2016
• Results First Posted: February 19, 2016

Record last verified: 2016-01

Locations

US (4)