BAY2586116 Nasal Spray and OSA Severity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2022-12-20

Brief Summary

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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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Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (saline) nasal spray application

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.

Group Type EXPERIMENTAL

BAY2586116

Intervention Type DRUG

160 μg BAY2586116 nasal spray application

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.

Group Type EXPERIMENTAL

BAY2586116

Intervention Type DRUG

160 μg BAY2586116 nasal spray application

Interventions

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BAY2586116

160 μg BAY2586116 nasal spray application

Intervention Type DRUG

Placebo

Placebo (saline) nasal spray application

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes