Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713826
Status:
COMPLETED
Last Update Posted:
2022-10-26
First Post:
2021-01-15
Brief Title:
A Trial to Learn More About How Well BAY2586116 Works and How Safe it is in Participants With Moderate to Severe Obstructive Sleep Apnea
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Proof-of-concept Multi-center Randomized Double-blind Placebo-controlled Two-way Crossover Study to Investigate the Effect Strength of BAY 2586116 on the Apnea-hypopnea-index After Repetitive Nasal Doses Compared to Placebo in 80 Valid Participants With Moderate to Severe Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPRAY-SMART
Brief Summary:
Researchers are looking for a better way to treat people with obstructive sleep apnea OSA In people with OSA the upper airways can narrow or close repetitively while sleeping These breathing interruptions lead to reduction of oxygen in the blood or short arousals from sleep Before a treatment can be approved for people to take researchers do clinical trials to better understand its safety and how well it works
In this trial the researchers want to learn more about how well BAY2586116 works in a small number of participants with OSA The trial will include about 160 men and women who have OSA and are at least 18 years old Women can only be included in this trial if they are not able to have children naturally
In this trial the participants will take BAY2586116 and a placebo A placebo looks like a treatment but does not have any medicine in it All of the participants will take BAY2586116 through a nasal spray They will also take the placebo as a nasal spray
This will be a crossover trial This means all the participants will take both trial treatments one after the other but in a different order The participants will take each treatment once a day for 7 days
The researchers will use a measurement called the apnea-hypopnea-index AHI to measure the severity of the participants OSA The researchers will then compare the participants AHI scores when they take BAY2586116 and when they take the placebo
During study the participants will visit their trial site 5 times At these visits the doctors will take blood samples do physical examinations and check the participants heart health using an electrocardiogram ECG They will also ask the participants questions about how they are feeling and if they have any medical problems At 3 of the visits the participants will stay at the trial site overnight At these visits the doctors will calculate the number of times the participants stop breathing per hour of sleep After treatment the participants will have a final visit 7 days later so the doctors can check their health
In this trial the researchers want to learn more about how well BAY2586116 works in a small number of participants with OSA The trial will include about 160 men and women who have OSA and are at least 18 years old Women can only be included in this trial if they are not able to have children naturally
In this trial the participants will take BAY2586116 and a placebo A placebo looks like a treatment but does not have any medicine in it All of the participants will take BAY2586116 through a nasal spray They will also take the placebo as a nasal spray
This will be a crossover trial This means all the participants will take both trial treatments one after the other but in a different order The participants will take each treatment once a day for 7 days
The researchers will use a measurement called the apnea-hypopnea-index AHI to measure the severity of the participants OSA The researchers will then compare the participants AHI scores when they take BAY2586116 and when they take the placebo
During study the participants will visit their trial site 5 times At these visits the doctors will take blood samples do physical examinations and check the participants heart health using an electrocardiogram ECG They will also ask the participants questions about how they are feeling and if they have any medical problems At 3 of the visits the participants will stay at the trial site overnight At these visits the doctors will calculate the number of times the participants stop breathing per hour of sleep After treatment the participants will have a final visit 7 days later so the doctors can check their health
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000520-19 | EUDRACT_NUMBER | None | None |