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

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).

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Minimal-Intervention - Specification of device settings

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Regina Schäfer; Phone Number: 23 004972182830; Email: regina.schaefer@loewensteinmedical.de
• Study Contact Backup: Name: Alexander Grimm; Phone Number: 28 004972182830; Email: alexander.grimm@loewensteinmedical.de

Study Locations

• Germany
  • Solingen, Germany, 42699
    • Recruiting
    • Wissenschaftliches Institut Bethanien e.V.
    • Contact: Winfried J. Randerath, Professor; Phone Number: 6001 004921263; Email: randerath@klinik-bethanien.de
    • Contact: Marcel Treml, PhD; Phone Number: 61 00492126366; Email: marcel.treml@klinik-bethanien.de
    • Principal Investigator: Winfried J. Randerath, Professor
    • Sub-Investigator: Wiebke Dorn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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 Names: Specification of device settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index (AHI /h TST)	number of apneas and hypopneas per hour of sleep time (TST)	2 days: change from recorded AHI in diagnostic PSG-acquistion to recorded AHI in treatment PSG-acquistion

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Heinen und Löwenstein GmbH & Co. KG
• Investigators: Study Director: Winfried J. Randerath, Professor, Wissenschaftliches Institut Bethanien e.V

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2018
• Study Completion (ANTICIPATED): March 1, 2018

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (ACTUAL): March 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 27, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; auto-CPAP; forced oscillation technique
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 16-pLINE-AC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO