BAY2586116 Nasal Spray and OSA Severity

NCT05527457 | Completed Phase 1

• 1 other identifier: 5468
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Change in OSA severity (BAY2586116 nasal only 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

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

  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)

  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)

  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)

  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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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.

Drug: BAY2586116

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.

Drug: BAY2586116

Interventions

BAY2586116 DRUG

160 μg BAY2586116 nasal spray application

BAY2586116 (nasal breathing only night); BAY2586116 (oro-nasal breathing night)

Placebo DRUG

Placebo (saline) nasal spray application

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Flinders University: lead
• Bayer: collaborator

Study Sites (1)

Flinders University

Bedford Park, South Australia, 5042, Australia

Location

Related Publications (1)

• 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.

  PMID: 34531274 BACKGROUND

Related Links

• Clinical trial registry for main KOALA study protocol (Parts A-C)

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Danny J. Eckert, PhD

  Flinders University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessor (sleep scorer) blinded to all 3 study arms. Investigator blinded to 2/3 arms.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Adelaide Institute for Sleep Health

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 2, 2022
• Study Start: August 31, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication
• Access Criteria: Available in the publication.

Locations

AU (1)