Back to results

BAY2586116 Nasal Spray and OSA Severity

Primary Purpose

Sleep Apnea, Obstructive

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

BAY2586116

Placebo

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Flinders University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

BAY2586116 (oro-nasal breathing night)

BAY2586116 (nasal breathing only night)

Arm Description

Placebo (saline) nasal spray, taken before bedtime. Dosage is taken on one instance for one night only.

BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the oro-nasal breathing night.

BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the nasal only breathing night.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.

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.

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.

Change in arousal index (BAY2586116 nights vs. placebo night)

Number of cortical arousals per hour of sleep during overnight in-laboratory polysomnography.

Change in sleep architecture (BAY2586116 nights vs. placebo night)

Proportion of sleep stages (% total sleep time) during overnight in-laboratory polysomnography.

Change in respiratory control (BAY2586116 nights vs. placebo night)

Loop gain and the ventilatory response to arousal (% eupnea) during overnight in-laboratory polysomnography.

Change in the respiratory arousal threshold (BAY2586116 nights vs. placebo night)

Threshold to arousal (% eupnea) during overnight in-laboratory polysomnography.

Change in airway collapsibility (BAY2586116 nights vs. placebo night)

Vpassive (% eupnea) during overnight in-laboratory polysomnography.

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)

Change in hypoxic burden (BAY2586116 nights vs. placebo night)

Hypoxic burden during sleep (%min/h) measured via pulse oximetry during overnight in-laboratory polysomnography.

Full Information

NCT ID

NCT05527457

First Posted

August 29, 2022

Last Updated

February 13, 2023

Sponsor

Flinders University

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT05527457

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

August 31, 2022 (Actual)

Primary Completion Date

December 20, 2022 (Actual)

Study Completion Date

December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Flinders University

Collaborators

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Participants and outcomes assessor (sleep scorer) blinded to all 3 study arms. Investigator blinded to 2/3 arms.

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (saline) nasal spray, taken before bedtime. Dosage is taken on one instance for one night only.

Arm Title

BAY2586116 (oro-nasal breathing night)

Arm Type

Experimental

Arm Description

BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the oro-nasal breathing night.

Arm Title

BAY2586116 (nasal breathing only night)

Arm Type

Experimental

Arm Description

BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the nasal only breathing night.

Intervention Type

Drug

Intervention Name(s)

BAY2586116

Intervention Description

160 μg BAY2586116 nasal spray application

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (saline) nasal spray application

Primary Outcome Measure Information:

Title

Description

Time Frame

Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart

Secondary Outcome Measure Information:

Title

Change in OSA severity (BAY2586116 nasal only breathing night vs. placebo night)

Description

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

Title

Change in OSA severity (BAY2586116 oro-nasal breathing night vs. placebo night)

Description

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

Title

Change in OSA severity (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night)

Description

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

Title

Change in nadir overnight hypoxemia (BAY2586116 nights vs. placebo night)

Description

Nadir overnight oxygen saturation during sleep (%) measured via pulse oximetry during overnight in-laboratory polysomnography.

Time Frame