DeVilbiss AutoAdjust With SmartFlex Comparative Study

April 8, 2015 updated by: DeVilbiss Healthcare LLC

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"

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75231
        • Sleep Medicine Associates of Texas
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SmartFlex
Use Continuous Airway Pressure device with SmartFlex engaged
Device: SmartFlex
Device used with smartflex engaged.
Other Names:
  • DeVilbiss AutoAdjust with SmartFlex
Active Comparator: Standard
Use Continuous Airway Pressure device without SmartFlex engaged
Device: Standard
Other Names:
  • DeVilbiss AutoAdjust without SmartFlex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-hypopnea Index (AHI)
Time Frame: 4 weeks
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)
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DeVilbiss Healthcare LLC

Investigators

  • Principal Investigator: Leon Rosenthal, MD, Sleep Medicine Associates of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

September 16, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHC-C001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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