Clinical trial NCT05527457: BAY2586116 Nasal Spray and OSA Severity
Official title: Effects of BAY2586116 on Obstructive Sleep Apnoea (OSA) Severity Informed by Upper Airway Physiology and the Role of Route of Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Flinders University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2022-09-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male or female participants aged 18 years or older at screening
* Must have completed Part A of the KOALA study (NCT04236440)
* Must be willing to sleep three nights in the sleep lab without OSA therapy (This includes continuous positive airway pressure therapy (CPAP) and/or a mandibular advancement device (MAD))
* Must be willing to refrain from drinking alcohol on the study days.
* Must be willing to limit consumption of tobacco to four cigarettes or one cigar a day and not smoke while at the sleep laboratory. This might be up to 12 hours.
* Must be willing to limit caffeinated beverage intake (coffee, tea, cola, and other soft drinks) to 400 mg / day or less of caffeine and not to be used within 4 hours of bedtime on study days.
* Contraceptive use required by men or women according to the methods of contraception for those participating in clinical studies

Exclusion Criteria:

* Any medications or herbal supplements that may interfere or be contraindicated with the study drug as determined by the investigator
* Severely impaired breathing within two days prior to randomization (e.g., acute nasal congestion during upper airway infection).
* known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations).
* Any other condition which at the discretion of the investigator would make the participant unsuitable for participation in the study and will not allow participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to less than 12 months)

Primary outcomes:
measure: 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
timeFrame: Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart
Secondary outcomes:
measure: Change in OSA severity (BAY2586116 nasal only breathing night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart
measure: Change in OSA severity (BAY2586116 oro-nasal breathing night vs. placebo night)
timeFrame: Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. placebo night) conducted approximately 1 week apart
measure: Change in OSA severity (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night)
timeFrame: Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night) conducted approximately 1 week apart
measure: Change in nadir overnight hypoxemia (BAY2586116 nights vs. placebo night)
timeFrame: 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
measure: Change in sleep efficiency (BAY2586116 nights vs. placebo night)
timeFrame: 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
measure: Change in arousal index (BAY2586116 nights vs. placebo night)
timeFrame: 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
measure: Change in sleep architecture (BAY2586116 nights vs. placebo night)
timeFrame: 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
measure: Change in respiratory control (BAY2586116 nights vs. placebo night)
timeFrame: 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
measure: Change in the respiratory arousal threshold (BAY2586116 nights vs. placebo night)
timeFrame: 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
measure: Change in airway collapsibility (BAY2586116 nights vs. placebo night)
timeFrame: 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
measure: Placebo OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (BAY2586116 nights vs. placebo night)
timeFrame: 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
measure: Change in hypoxic burden (BAY2586116 nights vs. placebo night)
timeFrame: 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
Other outcomes:
Locations:
city: Bedford Park
country: Australia
facility: Flinders University
state: South Australia
Study officials:
affiliation: Flinders University
name: Danny J. Eckert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.