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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (saline) nasal spray, taken before bedtime. Dosage is taken on one instance for one night only. |
|
| BAY2586116 (oro-nasal breathing night) | Experimental | BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the oro-nasal breathing night. |
|
| BAY2586116 (nasal breathing only night) | Experimental | BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the nasal only breathing night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY2586116 | Drug | 160 μg BAY2586116 nasal spray application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danny J. Eckert, PhD | Flinders University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flinders University | Bedford Park | South Australia | 5042 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34531274 | Background | Gaisl T, Turnbull CD, Weimann G, Unger S, Finger R, Xing C, Cistulli PA, West S, Chiang AKI, Eckert DJ, Stradling JR, Kohler M. BAY 2253651 for the treatment of obstructive sleep apnoea: a multicentre, double-blind, randomised controlled trial (SANDMAN). Eur Respir J. 2021 Nov 18;58(5):2101937. doi: 10.1183/13993003.01937-2021. Print 2021 Nov. |
| Label | URL |
|---|---|
| Clinical trial registry for main KOALA study protocol (Parts A-C) | View source |
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Individual data will be included in the study publication.
Upon publication
Available in the publication.
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Participants and outcomes assessor (sleep scorer) blinded to all 3 study arms. Investigator blinded to 2/3 arms.
| Placebo | Drug | Placebo (saline) nasal spray application |
|
| 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. | 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. | Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night) conducted approximately 1 week apart |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 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. | 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |