Sleep Disordered Breathing and Chronic Pain

Sleep Apnea Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457014
• Other study ID #: SDBPM-2011-01
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: January 22, 2016
• Start date: September 2011
• Est. completion date: September 2013

Study information

• Verified date: January 2016
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Sleep Apnea Syndromes

Intervention

Device:
• servo ventilation auto
Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
• Continuous positive airway pressure
continuous positive airway pressure
• servo ventilation manual
servo ventilation titrated in manual mode

Locations

Country	Name	City	State
United States	NeuroTrials Research Inc.	Atlanta	Georgia
United States	Sleep D/O Center of Alabama	Birmingham	Alabama
United States	Arkansas Center for Sleep Medicine	Little Rock	Arkansas
United States	Clayton Sleep Institute	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Percent Oxygen Saturation	Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.	four full night Polysomnography (PSG's)	No
Secondary	Number of Arterial Oxygen Saturation Per Hour	Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.	four full night Polysomnography (PSG's)	No