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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070756
Recruitment Status : Unknown
Verified December 2017 by Heinen und Löwenstein GmbH & Co. KG.
Recruitment status was:  Recruiting
First Posted : March 6, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Heinen und Löwenstein GmbH & Co. KG

Brief 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. The auto-CPAP algorithm examined in this study is implemented in the medical devices prisma20A and prismaLAB (Löwenstein Medical Technology).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Minimal-Intervention - Specification of device settings Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm in Patients With Predominantly Obstructive Sleep Apnea
Study Start Date : October 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
treatment group (auto-CPAP)

Participants 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).

Device: Minimal-Intervention - 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
Other Name: Specification of device settings




Primary Outcome Measures :
  1. 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 ]
    number of apneas and hypopneas per hour of sleep time (TST)


Secondary Outcome Measures :
  1. Obstructive Apnea-Hypopnea Index (oAHI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    number of obstructive apneas and hypopneas per hour of sleep time (TST)

  2. Obstructive Apnea Index (oAI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    number of obstructive apneas per hour of sleep time (TST)

  3. Central Apnea-Hypopnea Index (cAHI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    number of central apneas and hypopneas per hour of sleep time (TST)

  4. Oxygen Desaturation Index (ODI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    number of oxygen desaturations per hour of sleep time (TST)

  5. Arousal Index (ArI /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    number of arousals per hour of sleep time (TST)

  6. Respiratory Arousal Index (ArI_resp /h TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    number of respiratory arousals per hour of sleep time (TST)

  7. Snore (Snore /% TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    Percentage of total sleep time with snoring

  8. Slow-wave sleep (N3 /% TST) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    Percentage of total sleep time with slow wave sleep

  9. therapy pressure /hPa [ Time Frame: 1 day: treatment night (auto-CPAP) ]
    P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE

  10. leakage / l/min [ Time Frame: 1 day: treatment night (auto-CPAP) ]
    P95, percentage of therapy time with leakage > 50 l/min and median leakage during auto-CPAP treatment night.

  11. Time in Bed with oxygen saturation < 90% (SpO2 < 90 % / %TIB) [ Time Frame: 2 days: diagnostic and treatment PSG-acquistion ]
    Percentage of time in Bed with an oxygen sturation < 90 %



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070756


Contacts
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Contact: Regina Schäfer 004972182830 ext 23 regina.schaefer@loewensteinmedical.de
Contact: Alexander Grimm 004972182830 ext 28 alexander.grimm@loewensteinmedical.de

Locations
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Germany
Wissenschaftliches Institut Bethanien e.V. Recruiting
Solingen, Germany, 42699
Contact: Winfried J. Randerath, Professor    004921263 ext 6001    randerath@klinik-bethanien.de   
Contact: Marcel Treml, PhD    00492126366 ext 61    marcel.treml@klinik-bethanien.de   
Principal Investigator: Winfried J. Randerath, Professor         
Sub-Investigator: Wiebke Dorn, MD         
Sponsors and Collaborators
Heinen und Löwenstein GmbH & Co. KG
Investigators
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Study Director: Winfried J. Randerath, Professor Wissenschaftliches Institut Bethanien e.V
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Responsible Party: Heinen und Löwenstein GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT03070756    
Other Study ID Numbers: 16-pLINE-AC-1
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Heinen und Löwenstein GmbH & Co. KG:
auto-CPAP
forced oscillation technique
obstructive sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases