NCT05458193

A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DRUG	Daridorexant	Film-coated tablet for oral use
DRUG	Placebo	Film-coated tablet for oral use

Timeline

• Start date: 2022-08-17
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2022-07-14
• Last updated: 2023-04-04

Locations

1 site across 1 country: Germany