A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea

Janssen Research & Development, LLC34 enrolled

Overview

The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sleep Apnea, Obstructive

Interventions

Seltorexant 40 mgDRUG

Seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.

PlaceboDRUG

Matching placebo to seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant must be a women of non-childbearing potential (WONCBP) or man. A WONCBP is defined as: a) Postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; b) Permanently sterile (permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy * Meet the International Classification of Sleep Disorder diagnostic criteria for obstructive sleep apnea (OSA) based on the investigator's assessment with or without sleep study. The OSA diagnosis can be confirmed by previous sleep studies, appropriate documentations (for example, medical records or letters from treating physicians) or documented conversation with the treating physician * Mild to moderate OSA, defined as AHI greater than or equal to (\>=)5 to less than (\<)30, based on screening polysomnography (PSG) * Body mass index (BMI) between 18 and 40 kilogram per meter square (kg/m\^2) (inclusive) (BMI = weight/height\^2) * Must be otherwise healthy based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. If the results of the clinical laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities from normal to be not clinically significant or to be appropriate and reasonable for the population under study Exclusion Criteria: * Has a history of, or current signs and symptoms of, severe renal insufficiency (creatinine clearance \<30 milliliter per minute \[mL/min\]); moderate to severe hepatic insufficiency (Child-Pugh Score \>=7), significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic, or endocrine disorders (including uncontrolled hypo- or hyperthyroidism or diabetes mellitus). Participants with diabetes mellitus who are under good control (hemoglobin A1c \[HbA1c\] \<= 8.5 percent \[%\] and fasting glucose \<=140 milligram per deciliter \[mg/dL\] at screening) may be eligible to participate if otherwise medically healthy, and if on a stable regimen of glucose-lowering medications for at least 2 months prior to screening * Screening PSG with oxygen (O2) saturation \<=80% for \>=5% of total sleep time (TST) * Screening PSG with \>=10 periodic limb movements per hour associated with an arousal * Currently using or used within 7 days of screening a continuous positive airway pressure (CPAP), a dental appliance, or home oxygen use for OSA, or required to use any of them for the duration of the study * Has other respiratory disorders such as chronic obstructive pulmonary disease (COPD) or asthma that need systemic and/or inhaled steroids, bronchiectasis, or emphysema, documented by history or physical examination

Locations (4)

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

Clinilabs

New York, New York, United States

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, United States

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Apnea-Hypopnea Index (AHI) Score as Measured by Polysomnography (PSG)

AHI score is used to indicate the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as: Normal: AHI less than (\<)5, Mild sleep apnea: 5 less than or equal to (\<=) AHI \<15, Moderate sleep apnea: 15\<= AHI \<30, and Severe sleep apnea: AHI greater than or equal to (\>=)30.

Time frame: Day 4

Secondary Outcomes

AHI Score as Measured by PSG

AHI score is used to indicate the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as: Normal: AHI \<5, Mild sleep apnea: 5\<= AHI \<15, Moderate sleep apnea: 15\<= AHI \<30, and Severe sleep apnea: AHI \>=30.

Time frame: Day 1 (Night)

Mean Oxygen Saturation (SpO2) During Total Sleep Time (TST)

The mean SpO2 during TST on Night 4 and Night 1 will be assessed by continuous finger pulse oximetry.

Time frame: Nights 1 and 4

Mean SpO2 During Rapid Eye Movement (REM), Non-Rapid Eye Movement (NREM), and Awake Stages

The mean SpO2 during REM, NREM and awake stages of sleep will be assessed by continuous finger pulse oximetry.

Time frame: Nights 1 and 4

Percentage of Total Sleep Time with SpO2 less than 90 percent (%), 85%, and 80%

The percentage of TST with SpO2 level less than 90%, 85%, and 80% during the night, assessed by continuous finger pulse oximetry will be reported.

Time frame: Nights 1 and 4

Mean Latency to Persistent Sleep (LPS) as Assessed by PSG

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

LPS is a sleep parameter and will be measured by PSG during PSG screening. Elapsed time from the beginning of the PSG recording to the onset of the first 10 minutes of continuous sleep will be measured over 4 nights and the average time to sleep will be calculated.

Time frame: Nights 1 and 4

Wake After Sleep Onset (WASO) by PSG

WASO is a sleep parameter and will be measured by PSG during PSG screening. WASO is measured during overnight sleep laboratory PSG assessment and is defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over the first 6 hours of PSG assessment. The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.

Time frame: Nights 1 and 4

Sleep Efficiency (SE) by PSG

SE is a sleep parameter and will be measured by PSG during PSG screening. The total sleep time divided by the total time in bed (that is, the number of minutes from the beginning of the PSG recording to the end of the recording).

Time frame: Days 1, 2, 3, and 4

Total Sleep Time (TST)

TST is a sleep parameter and will be measured by PSG during PSG screening. All of the hours of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep, as measured by PSG, are summed to determine the TST.

Time frame: Nights 1 and 4

Rapid Eye Movement (REM) Sleep Latency

REM sleep is a normal stage of sleep characterized by the rapid and random movement of the eyes. REM sleep latency is the time from sleep onset until first period of REM sleep. PSG recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep).

Time frame: Nights 1 and 4

Total Duration of Rapid Eye Movement (REM) Sleep

PSG recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of epochs scored as REM sleep divided by 2.

Time frame: Nights 1 and 4

NREM Sleep Latency

NREM sleep latency is the time from sleep onset until first period of NREM sleep. Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: NREM sleep).

Time frame: Nights 1 and 4

Total Duration of NREM Sleep

Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: NREM sleep). It will be calculated as number of epochs scored as NREM sleep divided by 2.

Time frame: Nights 1 and 4

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.