N/A Completed N=28 Randomized Triple-blind Treatment

DeVilbiss AutoAdjust With SmartFlex Comparative Study

Obstructive Sleep Apnea

Source: ClinicalTrials.gov NCT01203956 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcomePrimary: Apnea-hypopnea Index (AHI) — 5.92; 5.56 events / hour

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Apnea-hypopnea Index (AHI)	5.92; 5.56	—
SECONDARY Key Measures That Will be Used to Evaluate the Intervention(s)	—	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01203956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.