Sleep Apnea, ObstructiveNCT00280800
Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Sleep Apnea
A study testing constant CPAP devices and automatic CPAP devices in people with Sleep Apnea, Obstructive, run by Konrad E. Bloch at 1 site in Switzerland.
Trial summary
Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances, objective vigilance, and it is cost-effective compared to conventional fixed continuous positive airway pressure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- constant CPAP devices and automatic CPAP devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Mar 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Excessive sleepiness, and Epworth Sleepiness Score > or = 8
- Apnea- Hypopnea-Index (AHI) > or = 10/hour
- Age 18-75
Who cannot join
- Psychophysiological incapacity to perform questionnaires
- Other sleep disorders
- Psychiatric disease requiring treatment
- Previous CPAP therapy
- Previous uvulopalatopharyngoplasty
- Chronic nasal obstruction that required treatment for more than 1 month
Show all 13Show fewer
- Cancer
- COPD, with FEV1 < 50% predicted
- Symptomatic cardiovascular disease requiring treatment defined as congestive heart failure > NYHA II
- Previous stroke with neurological residuum
- Cheyne-Stokes respiration
- Chronic pain syndromes, fibromyalgia
- Drug or alcohol addiction
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich
Zurich, CH-8091
About this study
Official title: Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Obstructive Sleep Apnea Syndrome
Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances, objective vigilance, and it is cost-effective compared to conventional fixed continuous positive airway pressure.
Read the detailed description
- To investigate whether computer controlled continuous positive airway pressure (autoCPAP) improves subjective sleepiness, quality of life, objective vigilance, and nocturnal respiration to a similar degree as conventional fixed continuous positive airway pressure in the initial phase of treatment and over the subsequent 2 years during home therapy
- To investigate the cost of autoCPAP compared to fixed CPAP therapy
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- constant CPAP devices, automatic CPAP devices
- Keywords
- randomized, controlled, double blind, effectiveness, auto CPAP, treatment, sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
constant CPAP devicesDevice
different CPAP mode
automatic CPAP devicesDevice
different CPAP mode
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | constant CPAP Receives: Device: constant CPAP devices |
| 2 | Experimental | automatic CPAP Receives: Device: automatic CPAP devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
subjective sleepiness and other OSAS symptoms
Measured: 3 months, 1 year, 2 years
quality of life
Measured: 3 months, 1 year, 2 years
percentage of withdrawal and cross-over to other CPAP mode
Measured: 3 months, 1 year, 2 years
objective vigilance
Measured: 3 months, 1 year, 2 years
blood pressure
Measured: 3 months, 1 year, 2 years
cost/utility ratios
Measured: 3 months, 1 year, 2 years
Secondary outcomes (5)
major outcomes in subgroups of patients with severe and mild OSAS
Measured: 3 months, 1 year, 2 years
circulating markers of inflammation and cardiovascular risk
Measured: 3 months, 1 year, 2 years
side effects
Measured: 3 months, 1 year, 2 years
nocturnal respiratory disturbances
Measured: 3 months, 1 year, 2 years
treatment adherence
Measured: 3 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konrad E. Bloch
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Kantonsspital Münsterlingen, Zuercher Hoehenklinik Wald, Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor-investigator, Konrad E. Bloch, University of Zurich
- Investigators
- Konrad E Bloch, MD, Study chair, Pulmonary Division and Sleep Disorders Center, University Hospital of Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280800
- Sponsor's protocol ID
- EK 1187
- Status last verified
- Oct 2017
- First submitted
- 20 Jan 2006
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Crook S, Sievi NA, Bloch KE, Stradling JR, Frei A, Puhan MA, Kohler M. Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials. Thorax. 2019 Apr;74(4):390-396. doi: 10.1136/thoraxjnl-2018-211959. Epub 2018 Aug 12.
PubMed 30100576Bloch KE, Huber F, Furian M, Latshang TD, Lo Cascio CM, Nussbaumer-Ochsner Y, Senn O, Russi EW, Kohler M, Schoch OD, Turk A, Imhof E, Laube I, Matthews F, Thurnheer R. Autoadjusted versus fixed CPAP for obstructive sleep apnoea: a multicentre, randomised equivalence trial. Thorax. 2018 Feb;73(2):174-184. doi: 10.1136/thoraxjnl-2016-209699. Epub 2017 Oct 5.
PubMed 28982804
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT00280800
- Acronym / sponsor ID
- EK 1187
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- randomized, controlled, double blind, effectiveness, auto CPAP, treatment, sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Konrad E. BlochUniversity, hospital or other
- Collaborators
- University of Zurich, Kantonsspital Münsterlingen, Zuercher Hoehenklinik Wald, Cantonal Hospital of St. Gallen
- Study start
- Jan 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 Jan 2006 (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.
Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances, objective vigilance, and it is cost-effective compared to conventional fixed continuous positive airway pressure.
Detailed description
- To investigate whether computer controlled continuous positive airway pressure (autoCPAP) improves subjective sleepiness, quality of life, objective vigilance, and nocturnal respiration to a similar degree as conventional fixed continuous positive airway pressure in the initial phase of treatment and over the subsequent 2 years during home therapy
- To investigate the cost of autoCPAP compared to fixed CPAP therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: constant CPAP devicesconstant CPAP |
| 2 | Experimental | Device: automatic CPAP devicesautomatic CPAP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Excessive sleepiness, and Epworth Sleepiness Score > or = 8
- Apnea- Hypopnea-Index (AHI) > or = 10/hour
- Age 18-75
Key exclusion criteria (13 listed)
- Psychophysiological incapacity to perform questionnaires
- Other sleep disorders
- Psychiatric disease requiring treatment
- Previous CPAP therapy
- Previous uvulopalatopharyngoplasty
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 |
|---|---|---|
| constant CPAP devicesdifferent CPAP mode | Device | 1 |
| automatic CPAP devicesdifferent CPAP mode | Device | 2 |
Primary outcome
subjective sleepiness and other OSAS symptoms
Time frame: 3 months, 1 year, 2 years
quality of life
Time frame: 3 months, 1 year, 2 years
percentage of withdrawal and cross-over to other CPAP mode
Time frame: 3 months, 1 year, 2 years
objective vigilance
Time frame: 3 months, 1 year, 2 years
blood pressure
Time frame: 3 months, 1 year, 2 years
cost/utility ratios
Time frame: 3 months, 1 year, 2 years
5 secondary outcomes
major outcomes in subgroups of patients with severe and mild OSAS
Time frame: 3 months, 1 year, 2 years
circulating markers of inflammation and cardiovascular risk
Time frame: 3 months, 1 year, 2 years
side effects
Time frame: 3 months, 1 year, 2 years
nocturnal respiratory disturbances
Time frame: 3 months, 1 year, 2 years
treatment adherence
Time frame: 3 months, 1 year, 2 years
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 30 Oct 2017.
- Derived from this study: PubMed 30100576Crook S, Sievi NA, Bloch KE, Stradling JR, Frei A, Puhan MA, Kohler M. Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials. Thorax. 2019 Apr;74(4):390-396. doi: 10.1136/thoraxjnl-2018-211959. Epub 2018 Aug 12.
- Derived from this study: PubMed 28982804Bloch KE, Huber F, Furian M, Latshang TD, Lo Cascio CM, Nussbaumer-Ochsner Y, Senn O, Russi EW, Kohler M, Schoch OD, Turk A, Imhof E, Laube I, Matthews F, Thurnheer R. Autoadjusted versus fixed CPAP for obstructive sleep apnoea: a multicentre, randomised equivalence trial. Thorax. 2018 Feb;73(2):174-184. doi: 10.1136/thoraxjnl-2016-209699. Epub 2017 Oct 5.
- Bloch KE et al. Thorax 2017;0:1-11Link provided by the sponsor.
- Link to publicationLink provided by the sponsor.
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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.
Konrad E Bloch, MD study chair
Pulmonary Division and Sleep Disorders Center, University Hospital of Zürich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing constant CPAP devices and automatic CPAP devices in people with Sleep Apnea, Obstructive, run by Konrad E. Bloch at 1 site in Switzerland.
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 13 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 30 Oct 2017. 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 Switzerland. 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?
subjective sleepiness and other OSAS symptoms (time frame: 3 months, 1 year, 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00280800, which also lists 2 linked publications.
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 30 Oct 2017.