This investigator-initiated study aims to determine the effects of BAY2586116 (a novel TASK channel blocker nasal spray) on sleep apnoea severity and the potential influence of route of breathing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
10
160 μg BAY2586116 nasal spray application
Placebo (saline) nasal spray application
Flinders University
Bedford Park, South Australia, Australia
Individual comparison between physiology changes in Pcrit during KOALA part A (NCT04236440) between BAY2586116 vs. placebo and change in AHI with BAY2586116 vs. placebo (nasal breathing) during current study
Individual changes in the critical closing pressure of the upper airway during sleep (Pcrit- measured in cmH2O) in KOALA part A (NCT04236440) will be compared to changes in the apnoea/hypopnoea index (AHI- measured as # of apnoeas and hypopneas per hour of sleep) between BAY2586116 (nasal breathing night) vs. placebo night
Time frame: Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart
Change in OSA severity (BAY2586116 nasal only breathing night vs. placebo night)
OSA severity as measured by the AHI (apnoea hypopnea index measured as # events/h sleep) during overnight in-laboratory polysomnography.
Time frame: Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart
Change in OSA severity (BAY2586116 oro-nasal breathing night vs. placebo night)
OSA severity as measured by the AHI (apnoea hypopnea index measured as # events/h sleep) during overnight in-laboratory polysomnography.
Time frame: Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. placebo night) conducted approximately 1 week apart
Change in OSA severity (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night)
OSA severity as measured by the AHI (apnoea hypopnea index measured as # events/h sleep) during overnight in-laboratory polysomnography.
Time frame: Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night) conducted approximately 1 week apart
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Change in nadir overnight hypoxemia (BAY2586116 nights vs. placebo night)
Nadir overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart
Change in sleep efficiency (BAY2586116 nights vs. placebo night)
Percent time spent asleep divided by the recording time from lights out to lights on during overnight in-laboratory polysomnography.
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart
Change in arousal index (BAY2586116 nights vs. placebo night)
Number of cortical arousals per hour of sleep during overnight in-laboratory polysomnography.
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart
Change in sleep architecture (BAY2586116 nights vs. placebo night)
Proportion of sleep stages (% total sleep time) during overnight in-laboratory polysomnography.
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart
Change in respiratory control (BAY2586116 nights vs. placebo night)
Loop gain and the ventilatory response to arousal (% eupnea) during overnight in-laboratory polysomnography.
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart
Change in the respiratory arousal threshold (BAY2586116 nights vs. placebo night)
Threshold to arousal (% eupnea) during overnight in-laboratory polysomnography.
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart
Change in airway collapsibility (BAY2586116 nights vs. placebo night)
Vpassive (% eupnea) during overnight in-laboratory polysomnography.
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart
Placebo OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (BAY2586116 nights vs. placebo night)
Exploratory analysis to determine if OSA endotypes (outcomes 8-11) are associated with changes in OSA severity (BAY2586116 nights vs. placebo night)
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart
Change in hypoxic burden (BAY2586116 nights vs. placebo night)
Hypoxic burden during sleep (%min/h) measured via pulse oximetry during overnight in-laboratory polysomnography.
Time frame: Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart