Obstructive Sleep Apnea
Conditions
Keywords
auto-CPAP, forced oscillation technique, obstructive sleep apnea
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.
Interventions
DEVICEMinimal-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
Sponsors
Heinen und Löwenstein GmbH & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI /h TST) | 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
| Measure | Time frame | Description |
|---|---|---|
| Obstructive Apnea Index (oAI /h TST) | 2 days: diagnostic and treatment PSG-acquistion | number of obstructive apneas per hour of sleep time (TST) |
| Central Apnea-Hypopnea Index (cAHI /h TST) | 2 days: diagnostic and treatment PSG-acquistion | number of central apneas and hypopneas per hour of sleep time (TST) |
| Oxygen Desaturation Index (ODI /h TST) | 2 days: diagnostic and treatment PSG-acquistion | number of oxygen desaturations per hour of sleep time (TST) |
| Arousal Index (ArI /h TST) | 2 days: diagnostic and treatment PSG-acquistion | number of arousals per hour of sleep time (TST) |
| Respiratory Arousal Index (ArI_resp /h TST) | 2 days: diagnostic and treatment PSG-acquistion | number of respiratory arousals per hour of sleep time (TST) |
| Obstructive Apnea-Hypopnea Index (oAHI /h TST) | 2 days: diagnostic and treatment PSG-acquistion | number of obstructive apneas and hypopneas per hour of sleep time (TST) |
| Slow-wave sleep (N3 /% TST) | 2 days: diagnostic and treatment PSG-acquistion | Percentage of total sleep time with slow wave sleep |
| therapy pressure /hPa | 1 day: treatment night (auto-CPAP) | P95, P90 and median treatment pressure (hPa) in auto-CPAP night with prismaLINE |
| leakage / l/min | 1 day: treatment night (auto-CPAP) | 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) | 2 days: diagnostic and treatment PSG-acquistion | Percentage of time in Bed with an oxygen sturation \< 90 % |
| Snore (Snore /% TST) | 2 days: diagnostic and treatment PSG-acquistion | Percentage of total sleep time with snoring |
Countries
Germany
Contacts
Primary ContactRegina Schäfer
Backup ContactAlexander Grimm
Outcome results
None listed