An interventional study of CPAP Titration using a Bilevel S/T mode with minimal pressure support and background rate in Sleep Apnea, Obstructive and Sleep Apnea, Central, sponsored by Heinen und Löwenstein GmbH & Co. KG. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by Heinen und Löwenstein GmbH & Co. KG · Not applicable, Interventional, and Treatment
Among 68 studies in Sleep Apnea, Obstructive with a site in Germany — 7 open to participants now, 13 under way, 5 of them phase 3. Sleep Apnea, Obstructive · Germany.
Among the 68 studies in Sleep Apnea, Obstructive with a site in Germany, this one is the 35th largest by planned enrollment of the 55 interventional ones that give a count, is one of 6 that started in 2016, is one of 38 with no phase, and was the 43rd registered.
2,242 studies on the registry are indexed under Sleep Apnea, Obstructive; 474 are open to participants now.
Browse Sleep Apnea, Obstructive studies →7 of the 68 studies in Sleep Apnea, Obstructive with a site in Germany are open now. Recruiting first, the newest first:
Novo Nordisk A/S · Sites in Germany, United States, Australia and 7 more countries
Ages 18+
Novo Nordisk A/S · Sites in Germany, United States, Australia and 7 more countries
Ages 18+
Eli Lilly and Company · Sites in Germany, United States, Australia and 8 more countries
Ages 18+
Inspire Medical Systems, Inc. · Sites in Germany, Austria, Belgium and 4 more countries
Ages 18+
Wissenschaftliches Institut Bethanien e.V · Sites in Germany, Belgium, France and 8 more countries
Ages 40+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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68 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 6 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 52 across 1,474 interventional studies indexed under Sleep Apnea, Obstructive.
Median enrollment 80 across the 55 interventional studies, 136 across the 13 observational. Of the 48 that completed or were terminated, 14 (29%) have results posted.
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51 of 68 have an industry lead sponsor. The 10 most frequent:
Heinen und Löwenstein GmbH & Co. KG is the lead sponsor of 2 studies on the registry; none are open to participants now.
Heinen und Löwenstein GmbH & Co. KG has 2 studies filed under Sleep Apnea, Obstructive — fewer than ten, so there is no comparison to draw.
3 of the studies in Sleep Apnea, Obstructive with a site in Germany that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07225686Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | 2027-08-20 |
| NCT07226765Phase 3AmgenMaridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy | 2027-08-30 |
| NCT06970171University Medicine GreifswaldAcceptance of Mandibular Advancement Devices | 2027-05-05 |
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Among the 68 studies in Sleep Apnea, Obstructive with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study analyzes the application of the Forced Breath Technique (FBT) to classify apneas during CPAP therapy with a prismaLAB (device name) therapy device.
In this study the BiLevel ST (Spontaneous / Timed) therapy mode of the prismaLAB device is reduced to a CPAP pressure profile with exhalation relief by minimization of the pressure gap between exhalation and inhalation pressure.
The FBT based apnea classification of the devices firmware is matched with the by hand scoring of the polysomnographic data that is usually used to evaluate the quality of patients sleep.
Obstructive sleep-disordered breathing is usually treated by positive airway pressure (PAP) therapy with respective devices.The devices detect, classify and store respiratory events as apneas, hypopneas and snoring to adapt the therapy pressure according to patients needs and/ or to validate therapy efficacy.
Since several years the Forced Breath Technique (FBT) is standard practice in PAP devices with a BiLevel pressure profile and a background rate to classify apneas as central or obstructive. In case of an interruption of the respiratory flow within an apnea the devices background rate applies so called "mandatory breaths" with neither a manually or by device defined pressure gap between exhalation and inhalation pressure (PDIFF). If a mandatory breath generates respiratory flow patients airways are open and the patient gets ventilated. In this case the detected apnea is classified as central. If a mandatory breath generates no or insufficient respiratory flow patients airways are impassable and the apnea is classified as an obstructive event.
Usually the size of the applied therapeutic pressure gap PDIFF is >= 4 hPa. If patients airways are open the mandatory breaths with PDIFF>= 4 hPa generate an obvious flow that submits a valid classification of apneas. Therefore the pressure gap should be preferably large. So, too, the pressure gap size should be defined as small as possible to prevent the impairment of patients sleep quality.
This pilot study targets to analyze if the application of FBT with a minor gap between inhalation and exhalation pressure (IPAP [inspiratory positive airway pressure] - EPAP [expiratory positive airway pressure] = PDIFF = 1,0 to 2,0 hPa) qualifies for an equal classification of apneas as with a PDIFF >= 4 hPa. Subsequently it serves to define the minimum size of this pressure gap.
To this effect the study is subdivided in to phases: an optimization phase and an evaluation phase.
The optimization phase targets to define the PDIFF size that enables the valid classification of apneas. The evaluation phase serves to compute the accuracy of the classification, the optimized algorithm and the determined classification criteria. Therefore this phase only takes place if the optimization phase yielded a result.
The optimization phase starts with a PDIFF of 1,5 hPa. If this PDIFF serves the purpose, the phase continues with a PDIFF of 1,0 hPa to analyze if a smaller pressure gap yields similar results. Otherwise the phase continues with a PDIFF of 2,0 hPa. Afterwards the optimization phase ends.
The review of the matching of the apneas classified by the device vs the manual scoring takes place after the synchronization of both sources.
Within every PDIFF round in the optimization phase patient recruitment takes place as long as at least 60 obstructive and 60 central apneas have been collected. To guarantee an equal dispersion of apneas on the patient population only 10 obstructive and 10 central apneas of each patient go down in the pool of apneas of the respective PDIFF round. The apnea extraction is made by randomization.
The evaluation phase runs with the determined PDIFF until at least 80 obstructive and 80 central apneas are collected.
The data evaluation occurs by use of descriptive statistics and based on fourfold tables.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria Statistical Evaluation:
Data of patients who completed the study protocol will be excluded from statistical analysis if one of the following criteria applies:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants of the study undergo the standard stages of the clinical routine within a PAP therapy setting: a diagnostic night followed by one or two treatment nights.
Other: CPAP Titration using a Bilevel S/T mode with minimal pressure support and background rate
The study performs within clinical routine with this exception that instead of the usually applied CPAP mode a modified BiLevel S/T mode is used. The modified BiLevel S/T mode meets the same requirements as the CPAP mode while providing the Forced Breath Technique to classify apneas as central or obstructive.
Accuracy of the mapping of apneas based on the Forced Breath Technique compared to the manual scoring of polysomnographic data
Time frame: 1 night (= first treatment night)
Started Mar 2016 (actual). Primary completion is estimated for Feb 2018, 22 months after the start.
Of 116 industry-sponsored interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 21. This study's planned 22 months is above that.
Counting every sponsor, half of 624 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Heinen und Löwenstein GmbH & Co. KG