Trial · NCT04647383
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
NCT04647383, Phase 1, Completed, Eisai Inc.; results first posted 2023-10-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04647383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04647383
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT04647383
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 63 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive, Respiration Disorders
- Interventions
- Placebo, Lemborexant 10 mg, Placebo, Lemborexant 10 mg
- First posted
- 2020-11-30
- Last updated
- 2023-10-10
- Results first posted
- 2023-10-10
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2 | Day 8 of Treatment Periods 1 and 2 (up to Day 30) | AHI was the number of apneas and hypopneas divided by the total sleep time (TST) (in minutes) and multiplied by 60 (minute per hour \[min/hour\]) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI greater than or equal to (\>=) 5 to less than (\<) 15 is classed as mild, AHI \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using polysomnography (PSG). |
| Primary | COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2 | Day 8 of Treatment Periods 1 and 2 (up to Day 30) | 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: AHI on Day 1 of Treatment Periods 1 and 2 | Day 1 of Treatment Periods 1 and 2 (up to Day 23) | AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI \>=5 to \<15 is classed as mild, \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using PSG. |
| Secondary | OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | 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 SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | 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: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | ODI was defined as (oxygen desaturations \>=3%\*60)/TST (that is, the average number of oxygen desaturations \>=3% per hour of sleep), as defined by the American Academy of Sleep Medicine. TST was defined as the total time asleep in minutes using PSG. |
| Secondary | OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | Desaturation was defined as decrease in the mean SpO2 of \>=3% (over the last 120 seconds) that lasts for at least 10 seconds. 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 | COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2 | Day 1 of Treatment Periods 1 and 2 (up to Day 23) | 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 | COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | AHI was the number of apneas and hypopneas divided by the TST (in minutes) and multiplied by 60 (min/hour) (that is, the average number of apneas and hypopneas per hour of sleep), as defined by the American Academy of Sleep Medicine. An AHI \>=5 to \<15 is classed as mild, \>=15 to \<30 as moderate, and AHI \>=30 as severe. TST was defined as the total time asleep in minutes using PSG. |
| Secondary | COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2 | Day 8 of Treatment Periods 1 and 2 (up to Day 30) | The pharmacodynamic (PD) analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | events (apnea plus hyponea) per hour | MEAN |
| PRIMARY | COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2 | Day 8 of Treatment Periods 1 and 2 (up to Day 30) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | percentage of oxygen saturation | MEAN |
| SECONDARY | OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2 | Day 1 of Treatment Periods 1 and 2 (up to Day 23) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | events (apnea plus hyponea) per hour | MEAN |
| SECONDARY | OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, number analyzed signifies those participants who were evaluable at given timepoint for this outcome measure. | percentage of oxygen saturation | MEAN |
| SECONDARY | OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, number analyzed signifies those participants who were evaluable at given timepoint for this outcome measure. | percentage of TST | MEAN |
| SECONDARY | OSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, number analyzed signifies those participants who were evaluable at given timepoint for this outcome measure. | events per hour | MEAN |
| SECONDARY | OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. Here, number analyzed signifies those participants who were evaluable at given timepoint for this outcome measure. | events (number of desaturations) | MEAN |
| SECONDARY | COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2 | Day 1 of Treatment Periods 1 and 2 (up to Day 23) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | percentage of oxygen saturation | MEAN |
| SECONDARY | COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | events (apnea plus hyponea) per hour | MEAN |
| SECONDARY | COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2 | Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30) | The PD analysis set for each cohort was the group of participants who had sufficient PD data to derive at least 1 primary PD parameter. | percentage of TST | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2 | OSA Cohort: Placebo | 45.09 | Standard Deviation 22.851 | events (apnea plus hyponea) per hour | |
| OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2 | OSA Cohort: Lemborexant 10 mg | 44.90 | Standard Deviation 22.246 | events (apnea plus hyponea) per hour | |
| COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2 | COPD Cohort: Placebo | 90.80 | Standard Deviation 2.565 | percentage of oxygen saturation | |
| COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2 | COPD Cohort: Lemborexant 10 mg | 91.27 | Standard Deviation 2.227 | percentage of oxygen saturation | |
| OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2 | OSA Cohort: Placebo | 44.65 | Standard Deviation 25.770 | events (apnea plus hyponea) per hour | |
| OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2 | OSA Cohort: Lemborexant 10 mg | 41.64 | Standard Deviation 21.215 | events (apnea plus hyponea) per hour | |
| OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2 | OSA Cohort: Placebo | Day 1 | 93.12 | Standard Deviation 2.073 | percentage of oxygen saturation |
| OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2 | OSA Cohort: Lemborexant 10 mg | Day 1 | 93.00 | Standard Deviation 2.462 | percentage of oxygen saturation |
| OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2 | OSA Cohort: Placebo | Day 8 | 93.44 | Standard Deviation 1.983 | percentage of oxygen saturation |
| OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2 | OSA Cohort: Lemborexant 10 mg | Day 8 | 93.06 | Standard Deviation 1.983 | percentage of oxygen saturation |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 (8 Days) | STARTED | OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg | 16 | |
| Treatment Period 1 (8 Days) | STARTED | OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo | 17 | |
| Treatment Period 1 (8 Days) | STARTED | COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg | 14 | |
| Treatment Period 1 (8 Days) | STARTED | COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo | 16 | |
| Treatment Period 1 (8 Days) | COMPLETED | OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg | 16 | |
| Treatment Period 1 (8 Days) | COMPLETED | OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo | 17 | |
| Treatment Period 1 (8 Days) | COMPLETED | COPD Cohort, Sequence C: Placebo + Lemborexant 10 mg | 14 | |
| Treatment Period 1 (8 Days) | COMPLETED | COPD Cohort, Sequence D: Lemborexant 10 mg + Placebo | 16 | |
| Treatment Period 1 (8 Days) | NOT COMPLETED | OSA Cohort, Sequence A: Placebo + Lemborexant 10 mg | 0 | |
| Treatment Period 1 (8 Days) | NOT COMPLETED | OSA Cohort, Sequence B: Lemborexant 10 mg + Placebo | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events20
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 | Somnolence | Nervous system disorders | OSA Cohort: Placebo | 0 | 33 | 0 |
| other | Somnolence | Nervous system disorders | OSA Cohort: Lemborexant 10 mg | 2 | 33 | 2 |
| other | Somnolence | Nervous system disorders | COPD Cohort: Placebo | 0 | 30 | 0 |
| other | Somnolence | Nervous system disorders | COPD Cohort: Lemborexant 10 mg | 0 | 30 | 0 |
| other | Headache | Nervous system disorders | OSA Cohort: Placebo | 0 | 33 | 0 |
| other | Headache | Nervous system disorders | OSA Cohort: Lemborexant 10 mg | 0 | 33 | 0 |
| other | Headache | Nervous system disorders | COPD Cohort: Placebo | 2 | 30 | 2 |
| other | Headache | Nervous system disorders | COPD Cohort: Lemborexant 10 mg | 1 | 30 | 1 |
| serious | SARS-CoV-2 test positive | Investigations | OSA Cohort: Placebo | 1 | 33 | 1 |
| serious | SARS-CoV-2 test positive | Investigations | OSA Cohort: Lemborexant 10 mg | 0 | 33 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OSA Cohort: Placebo | 0 | 33 |
| Total, all-cause mortality | OSA Cohort: Lemborexant 10 mg | 0 | 33 |
| Total, all-cause mortality | COPD Cohort: Placebo | 0 | 30 |
| Total, all-cause mortality | COPD Cohort: Lemborexant 10 mg | 0 | 30 |
| Total, other adverse events | OSA Cohort: Placebo | 0 | 33 |
| Total, other adverse events | OSA Cohort: Lemborexant 10 mg | 2 | 33 |
| Total, other adverse events | COPD Cohort: Placebo | 2 | 30 |
| Total, other adverse events | COPD Cohort: Lemborexant 10 mg | 1 | 30 |
| Total, serious adverse events | OSA Cohort: Placebo | 1 | 33 |
| Total, serious adverse events | OSA Cohort: Lemborexant 10 mg | 0 | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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.
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