A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT03796026
Phase
PHASE1
Status
Completed

Conditions

  • Sleep Apnea, Obstructive

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Seltorexant 40 mg — DRUG
    Seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.
  • Placebo — DRUG
    Matching placebo to seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.

Study Details

The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.

Key Dates

Start date
Jan 4, 2019
Status verified
Apr 2025
Primary completion
Jun 7, 2019
Completion
Jun 14, 2019

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Seltorexant Followed by Placebo
    Participants will receive seltorexant (40 milligram \[mg\] capsules) once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive matching placebo orally once daily for 4 consecutive days.
  • Experimental: Placebo Followed by Seltorexant
    Participants will receive placebo once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive seltorexant (40 mg capsules) orally once daily for 4 consecutive days.

Primary Outcome Measure

Apnea-Hypopnea Index (AHI) Score as Measured by Polysomnography (PSG) [ Time Frame: Day 4 ]

Locations (4)

FacilityCityStateZIPSite coordinators
NeuroTrials Research, Inc.AtlantaGeorgia30342-
ClinilabsNew YorkNew York10019-
CTI Clinical Trial and Consulting ServicesCincinnatiOhio45212-
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR companyKnoxvilleTennessee37923-

Find similar trials in Atlanta, GA

By research site
NeuroTrials Research, Inc.· Atlanta, GAClinilabs· New York, NYCTI Clinical Trial and Consulting Services· Cincinnati, OHAMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company· Knoxville, TN

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