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

Sponsor
Idorsia Pharmaceuticals Ltd.
Study ID
NCT05458193
Phase
PHASE1
Status
Completed

Conditions

  • Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daridorexant — DRUG
    Film-coated tablet for oral use
  • Placebo — DRUG
    Film-coated tablet for oral use

Study Details

A study on the effects of daridorexant on nighttime respiratory function in patients with severe obstructive sleep apnea (OSA).

Key Dates

Start date
Aug 17, 2022
Status verified
Apr 2023
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Daridorexant
    50 mg once daily from Day 1 to Day 5
  • Placebo Comparator: Placebo
    Matching placebo once daily from Day 1 to Day 5

Primary Outcome Measure

Treatment difference (daridorexant - placebo) for apnea/hypopnea index [ Time Frame: Night 5 of period 1 and period 2 (Total duration: 2 days) ]

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