Complex Sleep Apnea Syndrome
Conditions
Brief summary
The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.
Detailed description
Between 3 and 19% of patients with clinical and polysomnographic features of obstructive sleep apnea syndrome (OSA) develop a high-frequency of central apneas and/or disruptive Cheyne-Stokes respiratory syndrome after application of continuous positive airway pressure (CPAP), a pattern called the complex sleep apnea syndrome (CompSAS). The trial seeks to determine the efficacy of the ASV vs. CPAP modes for the treatment of CompSAS over time. Baseline clinical and laboratory data will be collected, patients will be randomized to one of the two treatments. Overall study participation is approximately 3 months.
Interventions
DEVICEVPAP Adapt SV
Comparison of ASV and CPAP modes
Sponsors
Mayo Clinic
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of complex sleep apnea syndrome (CompSAS) * Naive to PAP therapy * Requires CPAP ≤15 cm H2O
Exclusion criteria
* Requires supplemental oxygen or with a baseline SaO2 \<90% * Requires CPAP \> 15 cm H2O * Primary diagnosis of moderate to severe chronic obstructive pulmonary disease, neuromuscular disease, chronic hyperventilation, stroke, cognitive impairment, such that could impair ability to answer subjective questions (study questionnaires) or unstable heart failure * Any contraindication for nasal or oro-nasal positive airway pressure, such as claustrophobia, severe nasal obstruction, or impaired mental status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period | 3 months | AHI refers to the number of apneas and hypopneas that occurred per hour of sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) | 3 months | Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ASV Mode VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea | 33 |
| CPAP Mode VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | ASV Mode | CPAP Mode | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 11 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 22 Participants | 46 Participants |
| Age Continuous | 59.1 years STANDARD_DEVIATION 14.2 | 59.4 years STANDARD_DEVIATION 11.7 | 59.2 years STANDARD_DEVIATION 12.9 |
| Region of Enrollment United States | 33 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 26 Participants | 30 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 33 | 9 / 33 |
| serious Total, serious adverse events | 0 / 33 | 3 / 33 |
Outcome results
Primary
Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period
AHI refers to the number of apneas and hypopneas that occurred per hour of sleep
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ASV Mode | Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period | 4.4 AHI (events/hour) | Standard Deviation 9.6 |
| CPAP Mode | Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period | 9.9 AHI (events/hour) | Standard Deviation 11.1 |
Secondary
Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)
Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response.
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ASV Mode | Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) | Baseline SAQLI score | 4.6 units on a scale | Standard Deviation 1.2 |
| ASV Mode | Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) | End of study SAQLI score | 4.7 units on a scale | Standard Deviation 0.9 |
| CPAP Mode | Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) | Baseline SAQLI score | 4.5 units on a scale | Standard Deviation 0.9 |
| CPAP Mode | Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI) | End of study SAQLI score | 4.6 units on a scale | Standard Deviation 1.1 |