Obstructive Sleep Apnea
Conditions
Keywords
AutoAdjust, SmartFlex, Apnea Hypopnea Index, Patient reported outcomes
Brief summary
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
Interventions
DEVICESmartFlex
Device used with smartflex engaged.
DEVICEStandard
Sponsors
DeVilbiss Healthcare LLC
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
* Epworth Sleepiness Scale \>10 * Body Mass Index \> 26 * Apnea-hypopnea index (AHI) ≥15 (mod to severe range) * AHI ≤ 10 at therapeutic continuous positive airway pressure (CPAP) pressure * CPAP naïve patients * Polysomnogram (PSG) within 3 months of enrollment * Average oxygen saturation by pulse oximetry (SpO2) \> 90% during titration * Sleep efficiency on titration night ≥ 78%
Exclusion criteria
* Diagnosis of mild obstructive sleep apnea (OSA) * Co-morbid conditions which render participation to be at risk these may include patients with congestive heart failure, chronic obstructive pulmonary disease (COPD) or psychiatric illness * Allergies to mask materials * Difficulties with nasal breathing * Evidence of another primary sleep disorder * Evidence of arousing periodic limb movements during titration * Contraindications as listed on product labeling. * Pregnant * Currently diagnosed with depression if symptomatic * Predominately central sleep apnea * Deemed medically unsuitable by investigator * Evidence of any type of infection or treatment of an infectious condition during the period of research participation * Full Face Mask during titration * Have a bi-level requirement * CPAP pressure \>15cmH2O * Subjects with tracheotomy * Uncontrolled hypertension * Require supplemental oxygen * Stimulants, major tranquillizers or antipsychotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea Index (AHI) | 4 weeks | Number of apnea/hypopnea events per hour, measured by SmartLink component of device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Key Measures That Will be Used to Evaluate the Intervention(s) | 2 weeks | The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Evaluable Subjects All subjects completing both two-week periods of crossover study, with evaluable results for each period. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Two-week Period | Non-compliant: no evaluable results | 5 | 6 |
Baseline characteristics
| Characteristic | All Evaluable Subjects |
|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 9.9 |
| AHI (apnea-hypopnea index) | 39.8 events / hour STANDARD_DEVIATION 21.5 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 17 | 4 / 17 | 1 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 17 |
Outcome results
Primary
Apnea-hypopnea Index (AHI)
Number of apnea/hypopnea events per hour, measured by SmartLink component of device.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SmartFlex | Apnea-hypopnea Index (AHI) | 5.92 events / hour | Standard Deviation 3.75 |
| Standard | Apnea-hypopnea Index (AHI) | 5.56 events / hour | Standard Deviation 3.27 |
Secondary
Key Measures That Will be Used to Evaluate the Intervention(s)
The Epworth Sleepiness Scale will be used to evaluate sleepiness The Sleep Wake Activity Inventory will be used to evaluate sleepiness Daily diaries will be used to evaluate daily use of the device
Time frame: 2 weeks