Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-03 @ 4:20 AM
Study NCT ID:
NCT05458193
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
Sponsor:
Idorsia Pharmaceuticals Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Investigate the Effects of Daridorexant on Nighttime Respiratory Function and Sleep in Patients With Severe Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2023-04
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:
None
Brief Summary:
A study on the effects of daridorexant on nighttime respiratory function in patients with severe obstructive sleep apnea (OSA).
Detailed Description:
Each subject will participate in 2 study periods. Participants will receive 50 mg daridorexant in one period and placebo in the other period. Both periods will last from Day 1 (first administration) in the evening to Day 6 in the morning (defined as End-of-Period). The 2 periods will be separated by an in-between period of 1 to 2 weeks. An End-of-Study examination will take place 1 to 2 weeks after last administration of study treatment.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-000098-23 | EUDRACT_NUMBER | None | View |