Trials / Completed
CompletedNCT01457014
Sleep Disordered Breathing and Chronic Pain
BiPAP Adaptive Servo-Ventilation (AutoSV) Therapy in Patients With Chronic Pain and Sleep Disordered Breathing (SDB)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Philips Respironics · Industry
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | servo ventilation auto | Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow. |
| DEVICE | Continuous positive airway pressure | continuous positive airway pressure |
| DEVICE | servo ventilation manual | servo ventilation titrated in manual mode |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2013-04-01
- Completion
- 2013-09-01
- First posted
- 2011-10-21
- Last updated
- 2016-02-19
- Results posted
- 2016-02-19
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01457014. Inclusion in this directory is not an endorsement.