Obstructive Sleep Apnea SyndromeNCT00262366
Comparison of Automatic CPAP to Fixed CPAP for OSAS Following a Prediction Formula
A study testing Comparison of automatic CPAP versus fixed CPAP in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Comparison of automatic CPAP with fixed CPAP in patients with OSAS Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Comparison of automatic CPAP versus fixed CPAP
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- May 2005to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with proven Obstructive Sleep Apnea Syndrome
- Apnea-hypopnea-index > 20/h
- Awaking index > 30/h
Who cannot join
- Severe nasal obstruction
- Hypoventilation
- Excessive sleep fragmentation caused by non-respiratory factors
- COPD (FEV1/FVC < 65%)
- CPAP compliance < 3h per night
- Insufficient sleep time (< 2h TST) during one of both parts of the split night CPAP-titration
- Patients needing > 16 mbar CPAP pressures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS
Comparison of automatic CPAP with fixed CPAP in patients with OSAS
Read the detailed description
The polysomnography is divided into two parts, randomly assigned:
- in one part, the patient uses the automatic CPAP device in titration mode
- in the other part, the patient uses the CPAP device, in fixed mode according to the prediction formula
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Comparison of automatic CPAP versus fixed CPAP
- 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.
Comparison of automatic CPAP versus fixed CPAPDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
Arousal index
Pressure profile Auto-CPAP (P50, P95 en Pmax)
All outcomes are measured during polysomnography
Secondary outcomes (2)
Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability
Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startMay 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Dirk Pevernagie, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00262366
- Sponsor's protocol ID
- 2005/099
- Status last verified
- Dec 2007
- First submitted
- 4 Dec 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titration Efficacy of Automatic CPAP Versus Fixed CPAP, Following a Prediction Formula in Patients With OSAS
- ClinicalTrials.gov ID
- NCT00262366
- Acronym / sponsor ID
- 2005/099
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- May 2005
- Study completion
- Mar 2006 (actual)
- First posted
- 6 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of automatic CPAP with fixed CPAP in patients with OSAS
Detailed description
The polysomnography is divided into two parts, randomly assigned:
- in one part, the patient uses the automatic CPAP device in titration mode
- in the other part, the patient uses the CPAP device, in fixed mode according to the prediction formula
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with proven Obstructive Sleep Apnea Syndrome
- Apnea-hypopnea-index > 20/h
- Awaking index > 30/h
Key exclusion criteria (7 listed)
- Severe nasal obstruction
- Hypoventilation
- Excessive sleep fragmentation caused by non-respiratory factors
- COPD (FEV1/FVC < 65%)
- CPAP compliance < 3h per night
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 |
|---|---|---|
| Comparison of automatic CPAP versus fixed CPAP | Device | – |
Primary outcome
Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring
Arousal index
Pressure profile Auto-CPAP (P50, P95 en Pmax)
All outcomes are measured during polysomnography
2 secondary outcomes
Pressure adaptation during polysomnography according to body position and sleep stage, pressure variability
Measurements of comfort, subjective evaluation by the patient by questionnaires immediately after polysomnography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Website of the University Hospital GhentLink provided by the sponsor.
Related trials for Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Dirk Pevernagie, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of automatic CPAP versus fixed CPAP in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 7 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 Dec 2007. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Respiratory control expressed by residual number of obstructive and central apneas, hypopneas and snoring. The study lists 4 primary outcomes in all. 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 Dec 2007.