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OpenTrials
Completed

NCT Number: NCT01203956

DeVilbiss AutoAdjust With SmartFlex Comparative Study

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Medicine Associates of Texas, Dallas, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SmartFlex

Device

Device used with smartflex engaged.

Other names: DeVilbiss AutoAdjust with SmartFlex

Standard

Device

Other names: DeVilbiss AutoAdjust without SmartFlex

Primary outcomes

  1. Apnea-hypopnea Index (AHI)

    Time frame: 4 weeks

    Number of apnea/hypopnea events per hour, measured by SmartLink component of device.

Secondary outcomes

  1. Key Measures That Will be Used to Evaluate the Intervention(s)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

DeVilbiss Healthcare LLC

Industry

Registry information

Official study title

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"

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 17, 2010
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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