Central Sleep Apnea (Diagnosis), Chronic Opioid Use, Obstructive Sleep Apnea
Conditions
Keywords
sleeping, opioid medications, positive airway pressure
Brief summary
Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the chronic use of opioid medications
Detailed description
The trial seeks to determine the efficacy and patient comfort of ASV and bi-level positive airway pressure (PAP) modes for the treatment of obstructive sleep apnea (OSA), complicated by CSA secondary to opioid use. Subjects will be randomized to one of two groups, utilizing a cross-over design to evaluate the two modes with the subject as their own control. Subjects will be asked to undergo two PSG studies; one with ASV titration and one with bi-level treatment, using the current pressure prescription. The study comprises two visits. Subjects will be asked to complete patient satisfaction questionnaires following their PSG studies. It is anticipated that total subject participation will be no longer than one month.
Interventions
DEVICEAdaptive servo-ventilation (ASV)
Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual.
DEVICEBi-Level PAP
Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed.
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years old * Taking opioid medications for at least 6 months. Opioid medications include but are not limited to: oxycodone, fentanyl, methadone, levorphanol, hydromorphone, and morphine * Using bi-level PAP for at least 30 days
Exclusion criteria
* Primary heart or lung disease, for example: chronic obstructive pulmonary disease, pulmonary fibrosis, severe heart failure, uncorrected congenital heart disease, pulmonary hypertension * Primary neurologic disease, for example: neuromuscular disease, previous stroke or cognitive impairment * Narcolepsy * Acute upper respiratory tract infection * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | Up to 1 month | Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort | Up to 1 month | Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied |
Countries
United States
Participant flow
Recruitment details
All patients were recruited from a single sleep center in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population All study patients included in final analysis. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Continuous | 52.9 years |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
Primary
Apnea Hypopnea Index (AHI)
Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV).
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive Servo-Ventilation (ASV) | Apnea Hypopnea Index (AHI) | 2.5 events/hour | Standard Deviation 3.5 |
| Bi-Level PAP | Apnea Hypopnea Index (AHI) | 16.3 events/hour | Standard Deviation 20.9 |
Secondary
Patient Comfort
Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied
Time frame: Up to 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive Servo-Ventilation (ASV) | Patient Comfort | 76.0 units on a scale | Standard Deviation 27.2 |
| Bi-Level PAP | Patient Comfort | 67.8 units on a scale | Standard Deviation 28 |