Obstructive Sleep ApneaNCT01797705
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
A study testing DeVilbiss AutoAdjust CPAP with revised algorithm in people with Obstructive Sleep Apnea, run by DeVilbiss Healthcare LLC at 1 site in United States.
Trial summary
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- DeVilbiss AutoAdjust CPAP with revised algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2014
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apnea hypopnea index ≥ 15 / hour of sleep on the diagnostic polysomnogram, or diagnostic component of a split night polysomnogram
- Sleep efficiency reported on CPAP titration night PSG should be > 78%
- Diagnosis of moderate to severe obstructive sleep apnea (AHI ≥15) or central/complex sleep apnea
- On stable CPAP or APAP [Automatic Positive Airway Pressure] therapy, with compliant use averaging 4 or more hours nightly
- Age 21-75 years
- Predominately central sleep apnea for up to 10 subjects only
- Willingness to give written informed consent and ability to adhere to visit schedule
Who cannot join
- Diagnosis of mild sleep apnea
- CPAP naïve patients
- Co-morbid conditions which render participation to be at risk. These may include patients with congestive heart failure, COPD [Chronic Obstructive Pulmonary Disease] or psychiatric illness
- Allergies to mask materials
- Evidence of another primary sleep disorder
- Evidence of arousing periodic limb movements during titration
Show all 18Show fewer
- Contraindications as listed on product labeling
- Pregnant
- Currently diagnosed with depression if symptomatic
- Deemed medically unsuitable by investigator
- Evidence of any type of infection or treatment of an infectious condition during the period of research participation
- Have a bi-level requirement, or prescribed a bi-level therapy device
- CPAP pressure >15cmH2O
- Subjects with tracheotomy
- Uncontrolled hypertension
- Require supplemental oxygen
- Stimulants, major tranquillizers or antipsychotics
- Restless Leg Syndrome or Periodic Leg Movement Index of > 5 per hour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- DeVilbiss AutoAdjust CPAP with revised algorithm
- 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.
DeVilbiss AutoAdjust CPAP with revised algorithmDevice
Subjects attended a one-night polysomnogram (PSG) titration study. DeVilbiss AutoAdjust CPAP with a revised algorithm was compared to hand-scored PSG to determine whether the machine results were equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | All subjects underwent a sleep study with DeVilbiss AutoAdjust CPAP with revised algorithm simultaneously with hand-scored PSG. Receives: Device: DeVilbiss AutoAdjust CPAP with revised algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study
The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch.
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionMay 2014
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeVilbiss Healthcare LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797705
- Sponsor's protocol ID
- DHC-002
- Status last verified
- May 2015
- First submitted
- 8 Jan 2013
- Last updated
- 29 May 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 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revised Algorithm for Next Generation DeVilbiss AutoAdjust CPAP
- ClinicalTrials.gov ID
- NCT01797705
- Acronym / sponsor ID
- DHC-002
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- DeVilbiss Healthcare LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Feb 2013 (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.
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the DeVilbiss brand AutoAdjust CPAP device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: DeVilbiss AutoAdjust CPAP with revised algorithmAll subjects underwent a sleep study with DeVilbiss AutoAdjust CPAP with revised algorithm simultaneously with hand-scored PSG. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Apnea hypopnea index ≥ 15 / hour of sleep on the diagnostic polysomnogram, or diagnostic component of a split night polysomnogram
- Sleep efficiency reported on CPAP titration night PSG should be > 78%
- Diagnosis of moderate to severe obstructive sleep apnea (AHI ≥15) or central/complex sleep apnea
- On stable CPAP or APAP [Automatic Positive Airway Pressure] therapy, with compliant use averaging 4 or more hours nightly
- Age 21-75 years
Key exclusion criteria (18 listed)
- Diagnosis of mild sleep apnea
- CPAP naïve patients
- Co-morbid conditions which render participation to be at risk. These may include patients with congestive heart failure, COPD [Chronic Obstructive Pulmonary Disease] or psychiatric illness
- Allergies to mask materials
- 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 |
|---|---|---|
| DeVilbiss AutoAdjust CPAP with revised algorithmSubjects attended a one-night polysomnogram (PSG) titration study. DeVilbiss AutoAdjust CPAP with a revised algorithm was compared to hand-scored PSG to determine whether the machine results were equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure. | Device | All subjects |
Primary outcome
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study
Time frame: 1 night
The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an "agree" or "disagree." Pressure changes might show no change, increase or decrease during the 20-minute epoch.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeVilbiss AutoAdjust CPAP with revised algorithm in people with Obstructive Sleep Apnea, run by DeVilbiss Healthcare LLC at 1 site 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 7 inclusion and 18 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study (time frame: 1 night). 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 29 May 2015.