Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05527457




Registration number
NCT05527457
Ethics application status
Date submitted
29/08/2022
Date registered
2/09/2022
Date last updated
15/02/2023

Titles & IDs
Public title
BAY2586116 Nasal Spray and OSA Severity
Scientific title
Effects of BAY2586116 on Obstructive Sleep Apnoea (OSA) Severity Informed by Upper Airway Physiology and the Role of Route of Breathing
Secondary ID [1] 0 0
5468
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea, Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY2586116
Treatment: Drugs - Placebo

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

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

Experimental: BAY2586116 (nasal breathing only night) - BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the nasal only breathing night.


Treatment: Drugs: BAY2586116
160 µg BAY2586116 nasal spray application

Treatment: Drugs: Placebo
Placebo (saline) nasal spray application
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart
Secondary outcome [1] 0 0
Change in OSA severity (BAY2586116 nasal only breathing night vs. placebo night)
Timepoint [1] 0 0
Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart
Secondary outcome [2] 0 0
Change in OSA severity (BAY2586116 oro-nasal breathing night vs. placebo night)
Timepoint [2] 0 0
Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. placebo night) conducted approximately 1 week apart
Secondary outcome [3] 0 0
Change in OSA severity (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night)
Timepoint [3] 0 0
Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night) conducted approximately 1 week apart
Secondary outcome [4] 0 0
Change in nadir overnight hypoxemia (BAY2586116 nights vs. placebo night)
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Change in sleep efficiency (BAY2586116 nights vs. placebo night)
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Change in arousal index (BAY2586116 nights vs. placebo night)
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Change in sleep architecture (BAY2586116 nights vs. placebo night)
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Change in respiratory control (BAY2586116 nights vs. placebo night)
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Change in the respiratory arousal threshold (BAY2586116 nights vs. placebo night)
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Change in airway collapsibility (BAY2586116 nights vs. placebo night)
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Placebo OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (BAY2586116 nights vs. placebo night)
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Change in hypoxic burden (BAY2586116 nights vs. placebo night)
Timepoint [12] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/12/2022
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders University - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park

Funding & Sponsors
Primary sponsor type
Other
Name
Flinders University
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bayer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05527457
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Danny J. Eckert, PhD
Address 0 0
Flinders University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries