A Study to Evaluate the Respiratory Safety of Lemborexant in Adult and Elderly Participants With … (NCT04647383) | Clinical Trial Compass
CompletedPhase 1
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
United States63 participantsStarted 2021-01-06
Plain-language summary
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.
Who can participate
Age range45 Years – 90 Years
SexALL
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Inclusion criteria
✓. Male or female, age \>=45 and \<=90 at the time of informed consent
✓. Voluntary agreement and ability to provide written informed consent
✓. Body mass index (BMI) \<40 Kilogram per meter square (kg/m\^2)
✓. Reports habitually sleeping for at least 5.5 hours per night
✓. Reports habitual bedtime between 21:00 and midnight
✓. Agrees to stay in bed for 7 hours per night for the duration of the study
✓. At Screening Visit 2: Has completed the sleep diary for at least 5 consecutive nights
✓. At Screening Visit 2: Confirmation of mean habitual bedtime (MHB) between 21:00 and midnight (sleep diary)
Exclusion criteria
✕. Females of childbearing potential
✕. A current diagnosis of restless legs syndrome, periodic limb movement disorder, circadian rhythm sleep disorder, or narcolepsy
What they're measuring
1
OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment Periods 1 and 2
Timeframe: Day 8 of Treatment Periods 1 and 2 (up to Day 30)
2
COPD Cohort: Peripheral Oxygen Saturation (SpO2) During TST on Day 8 of Treatment Periods 1 and 2
Timeframe: Day 8 of Treatment Periods 1 and 2 (up to Day 30)
✕. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy
✕. A history of symptoms of rapid eye movement (REM) Behavior Disorder, sleep-related violent behavior, sleep-driving, or sleep-eating, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study
✕. Periodic Limb Movement with Arousal Index (PLMAI) as measured on the screening
✕. A prolonged QT interval by Fredericia (QTcF) (QTcF \>450 milliseconds \[ms\]) as demonstrated by a repeated electrocardiogram (ECG) at Screening
✕. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale \[C-SSRS\])
✕. Any lifetime suicidal behavior (per the Suicidal Behavior section of the C-SSRS) within 10 years of Screening