A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With Moderate to Severe Obstructive Sleep Apnea, and in Adult and Elderly Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease
Public ClinicalTrials.gov record NCT04647383. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Period, Crossover Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Subjects With Moderate to Severe Obstructive Sleep Apnea and Adult and Elderly Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of the study is to determine whether lemborexant increases the apnea hypopnea index (AHI) on Day 8 of treatment in adult and elderly participants (adults greater than or equal to \[\>=\] 45 to less than \[\<\] 65 years; elderly \>=65 to 90 years) with moderate to severe obstructive sleep apnea (OSA) compared with placebo, and using pulse oximetry determine whether lemborexant decreases the peripheral oxygen saturation (SpO2) during total sleep time (TST) on Day 8 of treatment in adult and elderly participants (adults \>=45 to \<65 years; elderly \>=65 to 90 years) with moderate to severe chronic obstructive pulmonary disease (COPD) compared with placebo.
Study identification
- NCT ID
- NCT04647383
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 63 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 45 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 6, 2021 (Actual)
- Primary completion
- Feb 10, 2022 (Actual)
- Completion
- Feb 10, 2022 (Actual)
- Last update posted
- Oct 10, 2023
2021 – 2022
United States locations
- U.S. sites
- 11
- U.S. states
- 5
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates | Glendale | Arizona | 85306 | — |
| Pacific Research Network | San Diego | California | 92103 | — |
| Teradan Clinical Trials | Brandon | Florida | 33511 | — |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| Clinical Trials of Florida, LLC | Miami | Florida | 33186 | — |
| Clinical Site Partners Orlando, LLC | Winter Park | Florida | 32789 | — |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30328 | — |
| GNP Research | Valdosta | Georgia | 31605 | — |
| CTI Clinical Trial & Consulting Services | Cincinnati | Ohio | 45212 | — |
| Intrepid Research, LLC | Cincinnati | Ohio | 45245 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04647383, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 10, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04647383 live on ClinicalTrials.gov.