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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
OSA: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
OSA: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
COPD: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
COPD: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
Pulmonary Associates
Glendale, Arizona, United States
Pacific Research Network
San Diego, California, United States
Teradan Clinical Trials
Brandon, Florida, United States
St. Francis Medical Institute
Clearwater, Florida, United States
Research Centers of America
Hollywood, Florida, United States
Clinical Trials of Florida, LLC
Miami, Florida, United States
Clinical Site Partners Orlando, LLC
Winter Park, Florida, United States
NeuroTrials Research Inc.
Atlanta, Georgia, United States
GNP Research
Valdosta, Georgia, United States
CTI Clinical Trial & Consulting Services
Cincinnati, Ohio, United States
...and 1 more locations
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2
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).
Time frame: Day 8 of Treatment Periods 1 and 2 (up to Day 30)
COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2
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.
Time frame: Day 8 of Treatment Periods 1 and 2 (up to Day 30)
OSA Cohort: AHI on Day 1 of Treatment Periods 1 and 2
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.
Time frame: Day 1 of Treatment Periods 1 and 2 (up to Day 23)
OSA Cohort: Peripheral SpO2 During TST on Days 1 and 8 of Treatment Periods 1 and 2
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.
Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
OSA Cohort: Percentage (%) of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
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.
Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
OSA Cohort: Mean Oxygen Desaturation Index (ODI) on Days 1 and 8 of Treatment Periods 1 and 2
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.
Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
OSA Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
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.
Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
COPD Cohort: Peripheral SpO2 During TST on Day 1 of Treatment Periods 1 and 2
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.
Time frame: Day 1 of Treatment Periods 1 and 2 (up to Day 23)
COPD Cohort: AHI on Days 1 and 8 of Treatment Periods 1 and 2
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.
Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
COPD Cohort: Percentage of TST During Which SpO2 Was <90%, <85% and <80% on Days 1 and 8 of Treatment Periods 1 and 2
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.
Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
COPD Cohort: Mean ODI on Days 1 and 8 of Treatment Periods 1 and 2
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.
Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
COPD Cohort: Absolute Number of Desaturations (>=3% Reduction From Baseline SpO2) on Days 1 and 8 of Treatment Periods 1 and 2
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.
Time frame: Days 1 and 8 of Treatment Periods 1 and 2 (up to Day 30)
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