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Sleep Disordered Breathing and Chronic Pain

Primary Purpose

Sleep Apnea Syndromes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

servo ventilation auto

Continuous positive airway pressure

servo ventilation manual

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring chronic pain, sleep disordered breathing, Opioids

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 < 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

Sites / Locations

Sleep D/O Center of Alabama
Arkansas Center for Sleep Medicine
NeuroTrials Research Inc.
Clayton Sleep Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

servo ventilation auto mode

Continuous positive airway pressure

servo ventilation manual

Arm Description

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

Airway pressure delivered at a constant pressure level.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Oxygen Saturation

Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.

Number of Arterial Oxygen Saturation Per Hour

Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.

Full Information

NCT ID

NCT01457014

First Posted

September 30, 2011

Last Updated

January 22, 2016

Sponsor

Philips Respironics

1. Study Identification

Unique Protocol Identification Number

NCT01457014

Brief Title

Sleep Disordered Breathing and Chronic Pain

Official Title

BiPAP Adaptive Servo-Ventilation (AutoSV) Therapy in Patients With Chronic Pain and Sleep Disordered Breathing (SDB)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Respironics

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea Syndromes

Keywords

chronic pain, sleep disordered breathing, Opioids

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

servo ventilation auto mode

Arm Type

Active Comparator

Arm Description

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

Arm Title

Continuous positive airway pressure

Arm Type

Active Comparator

Arm Description

Airway pressure delivered at a constant pressure level.

Arm Title

servo ventilation manual

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

servo ventilation auto

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Continuous positive airway pressure

Other Intervention Name(s)

CPAP

Intervention Description

continuous positive airway pressure

Intervention Type

Device

Intervention Name(s)

servo ventilation manual

Intervention Description

servo ventilation titrated in manual mode

Primary Outcome Measure Information:

Title

Number of Sleep Related Events Per Hour

Description

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

Time Frame

four full night Polysomnography (PSG's)

Secondary Outcome Measure Information:

Title

Percent Oxygen Saturation

Description

Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.

Time Frame

four full night Polysomnography (PSG's)

Title

Number of Arterial Oxygen Saturation Per Hour

Description

Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.

Time Frame

four full night Polysomnography (PSG's)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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 < 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Wylie, MD

Organizational Affiliation

Arkansas Center of Sleep Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vernon Pegram, PhD

Organizational Affiliation

Sleep D/O Center of Alabama

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark Muehlbach, PhD

Organizational Affiliation

Clayton Sleep Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Russell Rosenberg, MD

Organizational Affiliation

NeuroTrials Research, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sleep D/O Center of Alabama

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35213

Country

United States

Facility Name

Arkansas Center for Sleep Medicine

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

NeuroTrials Research Inc.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Clayton Sleep Institute

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

12. IPD Sharing Statement

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Sleep Disordered Breathing and Chronic Pain

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