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NCT03471871 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
A Phase 1 study of Obstructive Sleep Apnea and Healthy Subjects, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
- 11
- Study locations
NCT03471871: Completed Phase 1 study of Obstructive Sleep Apnea and Healthy Subjects, sponsored by Eisai.
NCT03471871 is a Phase 1 study of Obstructive Sleep Apnea and Healthy Subjects that has completed, run by Eisai. The registered enrollment target is 146 participants, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (34% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03471871, a Phase 1 study of Obstructive Sleep Apnea and Healthy Subjects, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
- 11
- Study locations
Study Summary
This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment and to determine whether it increases the apnea-hypopnea index after single and multiple doses of treatment in adult and elderly participants with mild obstructive sleep apnea (OSA).
Primary Outcome
SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using polysomnography (PSG).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lemborexant 10 mg
- DRUG Lemborexant 25 mg
Study Locations (11)
Arizona
- PACT - Glendale
- Pulmonary Associates, PA - Phoenix
Florida
- PAB Clinical Research - Brandon
- Research Centers of America - Hollywood
Maryland
- The Center for Sleep & Wake Disorders - Chevy Chase
- Advarra - Columbia
Ohio
- CTI Clinical Research Center - Cincinnati
- Community Research - Cincinnati
California
- Pacific Research Network. LLC - San Diego
Georgia
- Neurotrials Research, Inc - Atlanta
New York
- Clinilabs Drug Development - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2018-02-21 |
| Est. Completion | 2018-08-03 |
| Phase | Phase 1 |
What the finished NCT03471871 record still lists
NCT03471871 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (34% lower).
The record links to 2 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03471871 lists 11 locations in 7 states (Arizona, Florida, Maryland).
Frequently Asked Questions
What is clinical trial NCT03471871 about?
NCT03471871 is a clinical study titled "Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea". This study will be conducted to determine whether lemborexant as compared to placebo decreases the peripheral oxygen saturation during total sleep time in healthy adult and elderly participants after a single dose of treatment and to determine whether it increases the apnea-hypopnea index after sing...
What is the current status of trial NCT03471871?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2018-02-21. Estimated completion is 2018-08-03.
What conditions does trial NCT03471871 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Healthy Subjects.
What interventions are being tested in trial NCT03471871?
The interventions under investigation include: Placebo (DRUG), Lemborexant 10 mg (DRUG), Lemborexant 25 mg (DRUG).
Who is sponsoring clinical trial NCT03471871?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03471871 being conducted?
This trial has 11 study locations across Arizona, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obstructive Sleep Apnea
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03471871's enrollment target sits among peer trials
146 49th of 155 higher than 107 of 155 other Obstructive Sleep Apnea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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