Trial · NCT03471871
Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
NCT03471871, Phase 1, Completed, Eisai Inc.; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea. Trials, record NCT03471871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03471871
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Healthy Subjects and Adult and Elderly Subjects With Mild Obstructive Sleep Apnea
- NCT number
- NCT03471871
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 146 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Obstructive Sleep Apnea, Healthy Subjects
- Interventions
- Placebo, Lemborexant 10 mg, Lemborexant 25 mg, Placebo, Lemborexant 10 mg
- First posted
- 2018-03-21
- Last updated
- 2020-02-17
- Results first posted
- 2020-01-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment | Day 1 | 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). |
| Primary | OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment | Day 8 | The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe. |
| Secondary | HV Cohort: AHI on Day 1 of Treatment | Day 1 | The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe. |
| Secondary | OSA Cohort: AHI on Day 1 of Treatment | Day 1 | The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe. |
| Secondary | HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment | Day 1 | TST was defined as the total time asleep in minutes using PSG. 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. |
| Secondary | HV Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 of Treatment | Day 1 | 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 PSG. |
| Secondary | OSA Cohort: SpO2 During TST on Day 1 and Day 8 of Treatment | Day 1 and Day 8 | 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 PSG. |
| Secondary | OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment | Day 1 and Day 8 | TST was defined as the total time asleep in minutes using PSG. 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. |
| Secondary | OSA Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 and Day 8 of Treatment | Day 1 and Day 8 | 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 PSG. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment | Day 1 | Pharmacodynamic (PD) analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | percentage of oxygen saturation | MEAN |
| PRIMARY | OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment | Day 8 | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | events (apnea plus hyponea) per hour | MEAN |
| SECONDARY | HV Cohort: AHI on Day 1 of Treatment | Day 1 | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | events (apnea plus hyponea) per hour | MEAN |
| SECONDARY | OSA Cohort: AHI on Day 1 of Treatment | Day 1 | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. | events (apnea plus hyponea) per hour | MEAN |
| SECONDARY | HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment | Day 1 | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | percentage of TST | MEAN |
| SECONDARY | HV Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 of Treatment | Day 1 | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | percentage of participant | NUMBER |
| SECONDARY | OSA Cohort: SpO2 During TST on Day 1 and Day 8 of Treatment | Day 1 and Day 8 | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, 'number analyzed' signifies participants who were evaluable for analysis at the specified timepoints. | percentage of oxygen saturation | MEAN |
| SECONDARY | OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment | Day 1 and Day 8 | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, 'number analyzed' signifies participants who were evaluable for analysis at the specified timepoints. | percentage of TST | MEAN |
| SECONDARY | OSA Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 and Day 8 of Treatment | Day 1 and Day 8 | PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. | percentage of participant | NUMBER |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment | HV Cohort: Placebo | 95.34 | Standard Deviation 0.900 | percentage of oxygen saturation | |
| HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment | HV Cohort: Lemborexant 10 mg | 95.00 | Standard Deviation 1.283 | percentage of oxygen saturation | |
| HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment | HV Cohort: Lemborexant 25 mg | 95.07 | Standard Deviation 1.311 | percentage of oxygen saturation | |
| OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment | OSA Cohort: Placebo | 10.03 | Standard Deviation 6.799 | events (apnea plus hyponea) per hour | |
| OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment | OSA Cohort: Lemborexant 10 mg | 9.99 | Standard Deviation 5.878 | events (apnea plus hyponea) per hour | |
| HV Cohort: AHI on Day 1 of Treatment | HV Cohort: Placebo | 4.69 | Standard Deviation 8.183 | events (apnea plus hyponea) per hour | |
| HV Cohort: AHI on Day 1 of Treatment | HV Cohort: Lemborexant 10 mg | 5.29 | Standard Deviation 10.484 | events (apnea plus hyponea) per hour | |
| HV Cohort: AHI on Day 1 of Treatment | HV Cohort: Lemborexant 25 mg | 3.55 | Standard Deviation 6.585 | events (apnea plus hyponea) per hour | |
| OSA Cohort: AHI on Day 1 of Treatment | OSA Cohort: Placebo | 10.24 | Standard Deviation 7.094 | events (apnea plus hyponea) per hour | |
| OSA Cohort: AHI on Day 1 of Treatment | OSA Cohort: Lemborexant 10 mg | 10.29 | Standard Deviation 6.681 | events (apnea plus hyponea) per hour |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow95
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1(HV:1 Day, OSA:8 Days) | STARTED | HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg | 6 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | STARTED | HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo | 5 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | STARTED | HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg | 6 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | STARTED | OSA Cohort, Sequence D: Placebo, Lemborexant 10mg | 19 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | STARTED | OSA Cohort, Sequence E: Lemborexant 10mg, Placebo | 20 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | Treated | HV Cohort,Sequence A:Placebo,Lemborexant 10mg,Lemborexant 25mg | 6 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | Treated | HV Cohort,Sequence B:Lemborexant 10mg,Lemborexant 25mg,Placebo | 5 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | Treated | HV Cohort,Sequence C:Lemborexant 25mg,Placebo,Lemborexant 10mg | 6 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | Treated | OSA Cohort, Sequence D: Placebo, Lemborexant 10mg | 18 | |
| Treatment Period 1(HV:1 Day, OSA:8 Days) | Treated | OSA Cohort, Sequence E: Lemborexant 10mg, Placebo | 20 |
1 to 10 of 95Source ClinicalTrials.gov
See all 95 participant flowAdverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Photopsia | Eye disorders | HV Cohort: Placebo | 0 | 16 | |
| other | Photopsia | Eye disorders | HV Cohort: Lemborexant 10 mg | 0 | 16 | |
| other | Photopsia | Eye disorders | HV Cohort: Lemborexant 25 mg | 1 | 17 | |
| other | Photopsia | Eye disorders | OSA Cohort: Placebo | 0 | 38 | |
| other | Photopsia | Eye disorders | OSA Cohort: Lemborexant 10 mg | 0 | 38 | |
| other | Seasonal allergy | Immune system disorders | HV Cohort: Placebo | 0 | 16 | |
| other | Seasonal allergy | Immune system disorders | HV Cohort: Lemborexant 10 mg | 0 | 16 | |
| other | Seasonal allergy | Immune system disorders | HV Cohort: Lemborexant 25 mg | 1 | 17 | |
| other | Seasonal allergy | Immune system disorders | OSA Cohort: Placebo | 0 | 38 | |
| other | Seasonal allergy | Immune system disorders | OSA Cohort: Lemborexant 10 mg | 0 | 38 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HV Cohort: Placebo | 0 | 16 |
| Total, all-cause mortality | HV Cohort: Lemborexant 10 mg | 0 | 16 |
| Total, all-cause mortality | HV Cohort: Lemborexant 25 mg | 0 | 17 |
| Total, all-cause mortality | OSA Cohort: Placebo | 0 | 38 |
| Total, all-cause mortality | OSA Cohort: Lemborexant 10 mg | 0 | 38 |
| Total, other adverse events | HV Cohort: Placebo | 1 | 16 |
| Total, other adverse events | HV Cohort: Lemborexant 10 mg | 1 | 16 |
| Total, other adverse events | HV Cohort: Lemborexant 25 mg | 4 | 17 |
| Total, other adverse events | OSA Cohort: Placebo | 5 | 38 |
| Total, other adverse events | OSA Cohort: Lemborexant 10 mg | 6 | 38 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40848323 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03471871
GET https://conductscience.org/api/trials/v1/NCT03471871/results?page=2