DeVilbiss AutoAdjust With SmartFlex Comparative Study

Study Overview
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Brief Summary
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There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.

Official Title
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A Multi Center, Prospective, Randomized, Double Blind, Crossover Study to Compare the DeVilbiss AutoAdjust With and Without the Smartflex Device Modification; AutoAdjust With SmartFlex Study

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: SmartFlex
* Device: Standard


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmartFlex<br>Use Continuous Airway Pressure device with SmartFlex engaged | Device: SmartFlex<br>* Device used with smartflex engaged.<br>* Other names: DeVilbiss AutoAdjust with SmartFlex;|
| Active Comparator: Standard<br>Use Continuous Airway Pressure device without SmartFlex engaged | Device: Standard<br> <br> * Other names: DeVilbiss AutoAdjust without SmartFlex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopnea Index (AHI) | Number of apnea/hypopnea events per hour, measured by SmartLink component of device. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AutoAdjust, SmartFlex, Apnea Hypopnea Index, Patient reported outcomes