Obstructive Sleep ApneaNCT01203956
DeVilbiss AutoAdjust With SmartFlex Comparative Study
A study testing SmartFlex and Standard in people with Obstructive Sleep Apnea, run by DeVilbiss Healthcare LLC at 2 sites in United States.
Trial summary
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- SmartFlex and Standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sleep Medicine Associates of Texas
Dallas, Texas, 75231
Sleep Therapy and Research Center
San Antonio, Texas, 78229
About this study
Official 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"
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- SmartFlex, Standard
- Keywords
- AutoAdjust, SmartFlex, Apnea Hypopnea Index, Patient reported outcomes
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartFlexDevice
Also called DeVilbiss AutoAdjust with SmartFlex
Device used with smartflex engaged.
StandardDevice
Also called DeVilbiss AutoAdjust without SmartFlex
| Study group | Role | What they receive |
|---|---|---|
| SmartFlex | Experimental | Use Continuous Airway Pressure device with SmartFlex engaged Receives: Device: SmartFlex |
| Standard | Active comparator | Use Continuous Airway Pressure device without SmartFlex engaged Receives: Device: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea Index (AHI)
Number of apnea/hypopnea events per hour, measured by SmartLink component of device.
Measured: 4 weeks
Secondary outcomes (1)
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeVilbiss Healthcare LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Rosenthal, MD, Principal investigator, Sleep Medicine Associates of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203956
- Sponsor's protocol ID
- DHC-C001
- Status last verified
- Apr 2015
- First submitted
- 31 Aug 2010
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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"
- ClinicalTrials.gov ID
- NCT01203956
- Acronym / sponsor ID
- DHC-C001
- Conditions
- Obstructive Sleep Apnea
- Keywords
- AutoAdjust, SmartFlex, Apnea Hypopnea Index, Patient reported outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- DeVilbiss Healthcare LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Sep 2010 (estimated)
- Results
- Posted 28 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmartFlex | Experimental | Device: SmartFlexUse Continuous Airway Pressure device with SmartFlex engaged |
| Standard | Active comparator | Device: StandardUse Continuous Airway Pressure device without SmartFlex engaged |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartFlexAlso: DeVilbiss AutoAdjust with SmartFlexDevice used with smartflex engaged. | Device | SmartFlex |
| StandardAlso: DeVilbiss AutoAdjust without SmartFlex | Device | Standard |
Primary outcome
Apnea-hypopnea Index (AHI)
Time frame: 4 weeks
Number of apnea/hypopnea events per hour, measured by SmartLink component of device.
1 secondary outcome
Key Measures That Will be Used to Evaluate the Intervention(s)
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon Rosenthal, MD principal investigator
Sleep Medicine Associates of Texas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartFlex and Standard in people with Obstructive Sleep Apnea, run by DeVilbiss Healthcare LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-hypopnea Index (AHI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.