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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Minimal-Intervention - Specification of device settings
Sponsored by
Heinen und Löwenstein GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring auto-CPAP, forced oscillation technique, obstructive sleep apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wissenschaftliches Institut Bethanien e.V.Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

treatment group (auto-CPAP)

Arm Description

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).

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index (AHI /h TST)
number of apneas and hypopneas per hour of sleep time (TST)

Secondary Outcome Measures

Obstructive Apnea-Hypopnea Index (oAHI /h TST)
number of obstructive apneas and hypopneas per hour of sleep time (TST)
Obstructive Apnea Index (oAI /h TST)
number of obstructive apneas per hour of sleep time (TST)
Central Apnea-Hypopnea Index (cAHI /h TST)
number of central apneas and hypopneas per hour of sleep time (TST)
Oxygen Desaturation Index (ODI /h TST)
number of oxygen desaturations per hour of sleep time (TST)
Arousal Index (ArI /h TST)
number of arousals per hour of sleep time (TST)
Respiratory Arousal Index (ArI_resp /h TST)
number of respiratory arousals per hour of sleep time (TST)
Snore (Snore /% TST)
Percentage of total sleep time with snoring
Slow-wave sleep (N3 /% TST)
Percentage of total sleep time with slow wave sleep
therapy pressure /hPa
P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE
leakage / l/min
P95, percentage of therapy time with leakage > 50 l/min and median leakage during auto-CPAP treatment night.
Time in Bed with oxygen saturation < 90% (SpO2 < 90 % / %TIB)
Percentage of time in Bed with an oxygen sturation < 90 %

Full Information

First Posted
August 9, 2016
Last Updated
December 27, 2017
Sponsor
Heinen und Löwenstein GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT03070756
Brief Title
Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm
Official Title
Extended Evaluation of the Efficacy of a Proactive FOT-based Auto-CPAP Algorithm in Patients With Predominantly Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinen und Löwenstein GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
auto-CPAP, forced oscillation technique, obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group (auto-CPAP)
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Minimal-Intervention - Specification of device settings
Other Intervention Name(s)
Specification of device settings
Intervention Description
- 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
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI /h TST)
Description
number of apneas and hypopneas per hour of sleep time (TST)
Time Frame
2 days: change from recorded AHI in diagnostic PSG-acquistion to recorded AHI in treatment PSG-acquistion
Secondary Outcome Measure Information:
Title
Obstructive Apnea-Hypopnea Index (oAHI /h TST)
Description
number of obstructive apneas and hypopneas per hour of sleep time (TST)
Time Frame
2 days: diagnostic and treatment PSG-acquistion
Title
Obstructive Apnea Index (oAI /h TST)
Description
number of obstructive apneas per hour of sleep time (TST)
Time Frame
2 days: diagnostic and treatment PSG-acquistion
Title
Central Apnea-Hypopnea Index (cAHI /h TST)
Description
number of central apneas and hypopneas per hour of sleep time (TST)
Time Frame
2 days: diagnostic and treatment PSG-acquistion
Title
Oxygen Desaturation Index (ODI /h TST)
Description
number of oxygen desaturations per hour of sleep time (TST)
Time Frame
2 days: diagnostic and treatment PSG-acquistion
Title
Arousal Index (ArI /h TST)
Description
number of arousals per hour of sleep time (TST)
Time Frame
2 days: diagnostic and treatment PSG-acquistion
Title
Respiratory Arousal Index (ArI_resp /h TST)
Description
number of respiratory arousals per hour of sleep time (TST)
Time Frame
2 days: diagnostic and treatment PSG-acquistion
Title
Snore (Snore /% TST)
Description
Percentage of total sleep time with snoring
Time Frame
2 days: diagnostic and treatment PSG-acquistion
Title
Slow-wave sleep (N3 /% TST)
Description
Percentage of total sleep time with slow wave sleep
Time Frame
2 days: diagnostic and treatment PSG-acquistion
Title
therapy pressure /hPa
Description
P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE
Time Frame
1 day: treatment night (auto-CPAP)
Title
leakage / l/min
Description
P95, percentage of therapy time with leakage > 50 l/min and median leakage during auto-CPAP treatment night.
Time Frame
1 day: treatment night (auto-CPAP)
Title
Time in Bed with oxygen saturation < 90% (SpO2 < 90 % / %TIB)
Description
Percentage of time in Bed with an oxygen sturation < 90 %
Time Frame
2 days: diagnostic and treatment PSG-acquistion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regina Schäfer
Phone
004972182830
Ext
23
Email
regina.schaefer@loewensteinmedical.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Grimm
Phone
004972182830
Ext
28
Email
alexander.grimm@loewensteinmedical.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried J. Randerath, Professor
Organizational Affiliation
Wissenschaftliches Institut Bethanien e.V
Official's Role
Study Director
Facility Information:
Facility Name
Wissenschaftliches Institut Bethanien e.V.
City
Solingen
ZIP/Postal Code
42699
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Winfried J. Randerath, Professor
Phone
004921263
Ext
6001
Email
randerath@klinik-bethanien.de
First Name & Middle Initial & Last Name & Degree
Marcel Treml, PhD
Phone
00492126366
Ext
61
Email
marcel.treml@klinik-bethanien.de
First Name & Middle Initial & Last Name & Degree
Winfried J. Randerath, Professor
First Name & Middle Initial & Last Name & Degree
Wiebke Dorn, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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