NCT01203956

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
4 years until next milestone

Results Posted

Study results publicly available

April 28, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

August 31, 2010

Results QC Date

March 24, 2015

Last Update Submit

April 8, 2015

Conditions

Obstructive Sleep Apnea

Keywords

AutoAdjustSmartFlexApnea Hypopnea IndexPatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea Index (AHI)

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

    4 weeks

Secondary Outcomes (1)

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

    2 weeks

Study Arms (2)

SmartFlex

EXPERIMENTAL

Use Continuous Airway Pressure device with SmartFlex engaged

Device: SmartFlex

Standard

ACTIVE COMPARATOR

Use Continuous Airway Pressure device without SmartFlex engaged

Device: Standard

Interventions

SmartFlexDEVICE

Device used with smartflex engaged.

Also known as: DeVilbiss AutoAdjust with SmartFlex
SmartFlex
StandardDEVICE
Also known as: DeVilbiss AutoAdjust without SmartFlex
Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sleep Medicine Associates of Texas

Dallas, Texas, 75231, United States

Location

Sleep Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Weights and MeasuresInvestigative Techniques

Results Point of Contact

Title
Leon Rosenthal, MD
Organization
Sleep Medicine Associates of Texas
LRosenthal@sleepmed.com
214-750-7776

Study Officials

  • Leon Rosenthal, MD

    Sleep Medicine Associates of Texas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 17, 2010

Study Start

September 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 28, 2015

Results First Posted

April 28, 2015

Record last verified: 2015-04

Locations

US(2)