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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03070756
• Other study ID #: 16-pLINE-AC-1
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2016
• Last updated: December 27, 2017
• Start date: October 2016
• Est. completion date: March 2018

Study information

• Verified date: December 2017
• Source: Heinen und Löwenstein GmbH & Co. KG
• Contact: Regina Schäfer
• Phone: 004972182830
• Email: regina.schaefer[@]loewensteinmedical.de
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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

Locations

Country	Name	City	State
Germany	Wissenschaftliches Institut Bethanien e.V.	Solingen

Sponsors (1)

Lead Sponsor	Collaborator
Heinen und Löwenstein GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Obstructive Apnea Index (oAI /h TST)	number of obstructive apneas per hour of sleep time (TST)	2 days: diagnostic and treatment PSG-acquistion
Secondary	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
Secondary	Oxygen Desaturation Index (ODI /h TST)	number of oxygen desaturations per hour of sleep time (TST)	2 days: diagnostic and treatment PSG-acquistion
Secondary	Arousal Index (ArI /h TST)	number of arousals per hour of sleep time (TST)	2 days: diagnostic and treatment PSG-acquistion
Secondary	Respiratory Arousal Index (ArI_resp /h TST)	number of respiratory arousals per hour of sleep time (TST)	2 days: diagnostic and treatment PSG-acquistion
Secondary	Snore (Snore /% TST)	Percentage of total sleep time with snoring	2 days: diagnostic and treatment PSG-acquistion
Secondary	Slow-wave sleep (N3 /% TST)	Percentage of total sleep time with slow wave sleep	2 days: diagnostic and treatment PSG-acquistion
Secondary	therapy pressure /hPa	P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE	1 day: treatment night (auto-CPAP)
Secondary	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)
Secondary	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