Cheyne-Stokes Respiration, Sleep Apnea, Central
Conditions
Brief summary
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
Detailed description
Participants who qualify will be scheduled for one full night, attended diagnostic PSG, one full night attended continuous positive airway pressure (CPAP) titration, and one full night attended BiPAP autoSV Advanced titration PSG. Participants will be provided a BiPAP autoSV Advanced to use at home for 90 days.
Interventions
DEVICEBiPAP autoSV Advanced
The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
Sponsors
Philips Respironics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females, ages 21-75. 2. Able and willing to provide written informed consent. 3. Diagnosis of Central Sleep Apnea such as Hunter Cheyne Stokes Breathing, Complex Sleep Apnea, or Central Apnea with current daily Opioid use or any other predominant central sleep apnea. 1. For participants diagnosed with Hunter Cheyne Stokes Breathing, at least 3 cycles of crescendo-decrescendo breathing amplitude AND either a Central Apnea Index (CAI) ≥ 5/hour OR the crescendo-decrescendo cycles last at least 10 consecutive minutes from an attended Diagnostic Polysomnogram (PSG). 2. For participants diagnosed with Central Sleep Apnea with current daily Opioid use or any other predominant central sleep apnea, an Apnea/Hypopnea Index (AHI) ≥ 15 and CAI \> 5 from an attended Diagnostic PSG. 3. For participants diagnosed with Complex Sleep Apnea, an AHI ≥ 15 and CAI \> 5 from a CPAP titration. 4. Systolic blood pressure \> 80 mm Hg at Visit 1. 5. Agreement to undergo a full-night, attended Diagnostic PSG. 6. Agreement to undergo a full-night, attended CPAP titration PSG. 7. Agreement to undergo a full-night, attended BiPAP automatic Servo Ventilation (autoSV) Advanced titration PSG
Exclusion criteria
1. Active participation in another interventional research study. 2. Diagnosis of acute decompensated heart failure. 3. Surgery of the upper airway, nose, sinus or middle ear within the last 90 days. 4. Major medical or psychiatric condition that would interfere with the demands of the study or the ability to complete the study. For example, severe unstable chronic lung disease, neuromuscular disease, cancer, or end stage renal failure. 5. Qualifying for or awaiting heart transplantation. 6. Currently prescribed oxygen therapy (e.g. as needed, nocturnal, or continuous). 7. At home treatment with adapted Servo Ventilation (ASV) or Bilevel Positive Airway Pressure (PAP) therapies. 8. Unable to use PAP therapies due to physical (e.g. facial structural abnormalities) or cognitive (e.g. dementia) issues. 9. Participants in whom PAP therapy is medically contraindicated. 10. Uncontrolled hypertension (systolic ≥ 200 mm Hg/diastolic ≥ 120 mm Hg). 11. Narcolepsy. 12. Untreated Restless Legs Syndrome. 13. Periodic Limb Movement arousal index \> 20/hr.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea/Hypopnea Index (AHI) | During a single night of polysomnography lasting up to 8 hours. | To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale | 3 months | To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24. Interpretation: Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention. Score 16-24: Excessive sleepiness and patient should consider seeking medical attention A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness. |
| Breathing Event Indexes | from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment | To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy. Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment. |
| Average Therapy Pressure Values | 3 months | To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time. This analysis compares the average pressure support of the first week compared to the average pressure support to the final week. |
Countries
United States
Participant flow
Recruitment details
Twenty-nine patients were enrolled between September 2010 and February 2013. Two participants did not meet) criteria after centralized scoring of diagnostic and CPAP polysomnograms (PSGs) and were excluded from analysis. Twenty-seven participants (five women) completed 3 nights in-laboratory attended PSG, and 26 completed 3 months of follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic, Then CPAP, Then BiPAP autoSV Advanced Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design) | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| At Home (3 Months) | Lost to Follow-up | 1 |
| Sleep Laboratory (3 Nights) | Didn't meet inclusion/exclusion criteria | 2 |
Baseline characteristics
| Characteristic | Diagnostic, Then CPAP, Then BiPAP autoSV Advanced |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized African American | 1 participants |
| Race/Ethnicity, Customized African American, Irish, Native American | 1 participants |
| Race/Ethnicity, Customized Caucasian | 25 participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Apnea/Hypopnea Index (AHI)
To compare the AHI between the diagnostic CPAP titration and BiPAP autoSV Advanced PSG nights.
Time frame: During a single night of polysomnography lasting up to 8 hours.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic Apnea-Hypopnea Index | Apnea/Hypopnea Index (AHI) | 55 Apnea-Hypopnea events per hour | Standard Deviation 24 |
| Continuous Positive Airway Pressure Apnea-Hypopnea Index | Apnea/Hypopnea Index (AHI) | 37 Apnea-Hypopnea events per hour | Standard Deviation 22 |
| BiPAP autoSV Apnea-Hypopnea Index | Apnea/Hypopnea Index (AHI) | 12 Apnea-Hypopnea events per hour | Standard Deviation 20 |
Secondary
Average Therapy Pressure Values
To compare BiPAP autoSV Advanced therapy pressure values (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to determine if pressure requirements change over time. This analysis compares the average pressure support of the first week compared to the average pressure support to the final week.
Time frame: 3 months
Population: 26 participants completed the 3-month home follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic Apnea-Hypopnea Index | Average Therapy Pressure Values | First Week | 3.7 cm/H2O | Standard Deviation 2 |
| Diagnostic Apnea-Hypopnea Index | Average Therapy Pressure Values | Last Week | 3.9 cm/H2O | Standard Deviation 1.7 |
Secondary
Breathing Event Indexes
To determine if there are changes in breathing event indexes (Encore Pro Software) from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment to assess therapy efficacy. Values were determined by taking the average of the first 7 days of treatment and comparing them to the average of the last 7 days of treatment.
Time frame: from the first 7 days of BiPAP autoSV Advanced at home treatment to the last 7 days of at home treatment
Population: 26 participants completed the 3-month home follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic Apnea-Hypopnea Index | Breathing Event Indexes | First Week | 11.6 Apnea-Hypopnea events per hour | Standard Deviation 8.7 |
| Diagnostic Apnea-Hypopnea Index | Breathing Event Indexes | Last Week | 10.0 Apnea-Hypopnea events per hour | Standard Deviation 6.8 |
Secondary
Epworth Sleepiness Scale
To determine if there are changes in subjective sleepiness on the Epworth Sleepiness Scale (ESS) between Baseline (Visit 1) and 3 months (Visit 6). The ESS is an 8 question survey that determines sleepiness, each question is rated as a 0-3 will the total score ranging from 0-24. Interpretation: Score 0-7: Unlikely that there is abnormal sleep Score 8-9: Average amount of daytime sleepiness Score 10-15: Possible excessive sleepiness depending on the situation. Patient may want to consider seeking medical attention. Score 16-24: Excessive sleepiness and patient should consider seeking medical attention A decrease in the score indicates improvements in a patients overall sleepiness. An increase in the score indicates increased sleepiness.
Time frame: 3 months
Population: 26 participants completed the 3-month home follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Diagnostic Apnea-Hypopnea Index | Epworth Sleepiness Scale | Baseline (visit 1) | 12.8 units on a scale | Standard Deviation 5 |
| Diagnostic Apnea-Hypopnea Index | Epworth Sleepiness Scale | 3 months (visit 6) | 7.8 units on a scale | Standard Deviation 4 |