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Obstructive Sleep ApneaNCT03070756

Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm

A study testing Minimal-Intervention - Specification of device settings in people with Obstructive Sleep Apnea, run by Heinen und Löwenstein GmbH & Co. KG at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study implements an extended (post marked) examination of the efficacy of a proactive auto-CPAP algorithm, which is based on the forced oscillation technique (FOT) in a sample of patients with predominantly obstructive sleep apnea. 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?
Minimal-Intervention - Specification of device settings
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteGermany
Study dates
Oct 2016to Mar 2018
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

  • Apnea-Hypopnea Index (AHI) > 15,0 (n/h Total Sleep Time)
  • Initial diagnosis of predominant obstructive sleep apnea (percentage of central respiratory events < 20 %)
  • informed written consent

Who cannot join

  • missing informed written consent
  • Participation in another clinical trial that influences the initiation of auto-CPAP treatment by specifications of device settings or titration procedure
  • acute cardiac decompensation
  • severe arrhythmia
  • severe hypotension, particularly in combination with intravascular volume depletion
  • severe epistaxis
Show all 24Show fewer
  • high risk of barotrauma
  • decompensated pulmonary conditions
  • pneumothorax or pneumomediastinum
  • pneumocephalus
  • cranial trauma
  • status following brain surgery or surgical intervention on the pituitary gland or the middle/inner ear
  • acute sinus infection (sinusitis), middle ear infection (otitis media) or perforated eardrum
  • dehydration
  • Data of patients who completed the study protocol will be excluded from statistical analysis if one of the following criteria applies:
  • non adherence to in-/exclusion criteria
  • AHI <= 15,0 (n/h TST) or percentage of central respiratory events >= 20% in the second, study specific PSG-diagnostic night
  • application of incorrect device settings
  • insufficient data quality of PSG-acquisition
  • the device was applied outside range of indication
  • data of diagnostic night are not acquired as a PSG
  • total time of softSTART duration exceeded 60 min
  • the auto-CPAP device was restarted >= 3 times during the treatment night. Recurrent reductions of device therapy pressure to start level (device restarts) which are applied within a time frame of <= 5 minutes after another restart will be assigned to previous restart und therefore numbered as one. Restarts which take place before initial falling asleep will not be numbered.
  • the application time of the auto-CPAP device was <6h during treatment night

Trial locations and contacts

1 site in 1 country.

Regina Schäfer contact

004972182830 ext. 23

regina.schaefer@loewensteinmedical.de

Alexander Grimm contact

004972182830 ext. 28

alexander.grimm@loewensteinmedical.de

Germany1 site, 1 recruiting

  • Wissenschaftliches Institut Bethanien e.V.

    Solingen, 42699

    Winfried J. Randerath, Professor, 004921263 ext. 6001, randerath@klinik-bethanien.de

    Marcel Treml, PhD, 00492126366 ext. 61, marcel.treml@klinik-bethanien.de

    Recruiting

Other trials in Germany

About this study

Official title: Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm in Patients With Predominantly Obstructive Sleep Apnea

This study implements an extended (post marked) examination of the efficacy of a proactive auto-CPAP algorithm, which is based on the forced oscillation technique (FOT) in a sample of patients with predominantly obstructive sleep apnea. The auto-CPAP algorithm examined in this study is implemented in the medical devices prisma20A and prismaLAB (Löwenstein Medical Technology).

Read the detailed description

Patients diagnosed with obstructive sleep apnea and who comply with inclusion criteria of the study will be informed about the possibility of participation. Following informed and written consent, participants will undergo a PSG-diagnostic night according to clinical routine, followed by an auto-CPAP treatment night with a prismaLINE device (prismaLAB or prisma20A). The device settings applied in the treatment night are defined by the study protocol (see interventions). Following the auto-CPAP treatment night, study participation is completed. Any following treatment and patient care is administered according to clinical routine.

Primary and secondary outcome measures of sleep stage and respiratory event indices are evaluated at diagnostic night and auto-CPAP treatment night.

The enrollment consists of two phases. During phase 1 (training phase) 10 participants are enrolled and complete the study protocol. Phase 1 serves as a training phase to establish a common standard of data quality and acquisition. Data of the training phase are not included in the statistical analysis. Following the training phase the efficacy of the auto-CPAP algorithm is evaluated in a sample of 70 participants.

Being tested
Minimal-Intervention - Specification of device settings
Keywords
auto-CPAP, forced oscillation technique, obstructive sleep apnea
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.

  • Minimal-Intervention - Specification of device settingsDevice

    Also called Specification of device settings

    • device settings for auto-CPAP treatment night: therapy mode=APAP, Pmin=5hPa,Pmax=20 hPa, Soft-Start duration <=15 min, softPAP Level is selected based on patient comfort
Study groups in NCT03070756
Study groupRoleWhat they receive
treatment group (auto-CPAP)OtherParticipants of this study undergo an diagnostic PSG night. The diagnostic night is followed by an auto-CPAP treatment night. Interventions: The treatment night is in line with the routine procedure of the laboratory except the following intervention: the device settings for the treatment night are applied according to the study protocol (minimal intervention).
Receives: Device: Minimal-Intervention - Specification of device settings

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apnea-Hypopnea Index (AHI /h TST)

    number of apneas and hypopneas per hour of sleep time (TST)

    Measured: 2 days: change from recorded AHI in diagnostic PSG-acquistion to recorded AHI in treatment PSG-acquistion

Secondary outcomes (11)

  1. Obstructive Apnea-Hypopnea Index (oAHI /h TST)

    number of obstructive apneas and hypopneas per hour of sleep time (TST)

    Measured: 2 days: diagnostic and treatment PSG-acquistion

  2. Obstructive Apnea Index (oAI /h TST)

    number of obstructive apneas per hour of sleep time (TST)

    Measured: 2 days: diagnostic and treatment PSG-acquistion

  3. Central Apnea-Hypopnea Index (cAHI /h TST)

    number of central apneas and hypopneas per hour of sleep time (TST)

    Measured: 2 days: diagnostic and treatment PSG-acquistion

  4. Oxygen Desaturation Index (ODI /h TST)

    number of oxygen desaturations per hour of sleep time (TST)

    Measured: 2 days: diagnostic and treatment PSG-acquistion

  5. Arousal Index (ArI /h TST)

    number of arousals per hour of sleep time (TST)

    Measured: 2 days: diagnostic and treatment PSG-acquistion

  6. Respiratory Arousal Index (ArI_resp /h TST)

    number of respiratory arousals per hour of sleep time (TST)

    Measured: 2 days: diagnostic and treatment PSG-acquistion

  7. Snore (Snore /% TST)

    Percentage of total sleep time with snoring

    Measured: 2 days: diagnostic and treatment PSG-acquistion

  8. Slow-wave sleep (N3 /% TST)

    Percentage of total sleep time with slow wave sleep

    Measured: 2 days: diagnostic and treatment PSG-acquistion

  9. therapy pressure /hPa

    P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE

    Measured: 1 day: treatment night (auto-CPAP)

  10. leakage / l/min

    P95, percentage of therapy time with leakage > 50 l/min and median leakage during auto-CPAP treatment night.

    Measured: 1 day: treatment night (auto-CPAP)

  11. Time in Bed with oxygen saturation < 90% (SpO2 < 90 % / %TIB)

    Percentage of time in Bed with an oxygen sturation < 90 %

    Measured: 2 days: diagnostic and treatment PSG-acquistion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2017
  2. Study startOct 2016
  3. Primary completionJan 2018 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03070756
Sponsor's protocol ID
16-pLINE-AC-1
Status last verified
Dec 2017
First submitted
9 Aug 2016
Last updated
29 Dec 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Minimal-Intervention - Specification of device settings in people with Obstructive Sleep Apnea, run by Heinen und Löwenstein GmbH & Co. KG at 1 site in Germany.

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 24 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: status not confirmed, as of the sponsor's last update on 29 Dec 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 Germany. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Regina Schäfer (004972182830 ext. 23, regina.schaefer@loewensteinmedical.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea-Hypopnea Index (AHI /h TST) (time frame: 2 days: change from recorded AHI in diagnostic PSG-acquistion to recorded AHI in treatment PSG-acquistion). 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 NCT03070756.

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 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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