Back to resultsA Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Seltorexant 40 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
Eligibility Criteria
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
Sites / Locations
- NeuroTrials Research, Inc.
- Clinilabs
- CTI Clinical Trial and Consulting Services
- AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Seltorexant Followed by Placebo
Placebo Followed by Seltorexant
Arm Description
Participants will receive seltorexant (40 milligram [mg] capsules) once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive matching placebo orally once daily for 4 consecutive days.
Participants will receive placebo once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive seltorexant (40 mg capsules) orally once daily for 4 consecutive days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Mean Latency to Persistent Sleep (LPS) as Assessed by PSG
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.
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.
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).
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.
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).
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.
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).
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.
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.
Percentage of Participants with all Serious Adverse Events (SAEs) and Events of Special Interest
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All SAEs and events of special interest including cataplexy (sudden, transient episode of muscle weakness accompanied by conscious awareness), sleep paralysis (the experience of not being able to move, react, or speak when falling asleep/awakening), and complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (Rapid Eye Movement [REM]-associated end-inspiratory apnea/breath holding) will be reported.
Number of Participants with Clinically Significant Vital Signs Abnormalities
Number of participants with clinically significant abnormalities in the vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure will be reported.
Number of Participants with Clinically Significant Physical Examination Abnormalities
Number of participants with clinically significant abnormalities in the physical examination including examination of height, body weight, and waist circumference will be reported.
Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities
Number of participants with clinically significant abnormalities in the ECG will be reported.
Number of Participants with Clinically Significant Laboratory Abnormalities
Blood samples for serum chemistry, hematology, and urinalysis will be collected for clinical laboratory testing.
Number of participants with suicidal ideation measured using Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation indicates an increase in severity of suicidal ideation from baseline.
Bond-Lader Visual Analog Scales (B-L VAS) Score
The B-L VAS is a patient-rated scale designed to assess the current level of sedation and consists of sixteen 100-milliliter (mm) VAS anchored by antonyms (Alert-Drowsy, Lethargic-Energetic). Scores are combined to form 3 mood factors: alertness, calmness, and contentedness. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy).
Next-Day Residual Effect Measured by the Karolinska Sleepiness Scale (KSS) Score
The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a 9-point Likert scale with response options from: 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep).
Residual Effect on a Cognitive Test Battery Evaluated by Symbol Digit Modalities Test (SDMT)
The SDMT is a widely used, paper-and-pencil assessment of complex scanning and visual tracking, requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The test is viewed as a robust screening test for adult neuropsychological impairment and has been used to demonstrate worse cognitive functioning in patients with MDD. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to write the number corresponding to each symbol as fast as possible. The number of correct substitutions within 90 seconds is recorded by examiner-administered cognitive test battery.
Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B)
The TMT-B measures divided attention and executive function (tracking and sequencing). The participant is instructed to draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters (that is, 1-A-2-B). The participant is instructed to work as quickly as possible while still maintaining accuracy. The TMT-B has acceptable reliability; reliability coefficients have typically been reported as exceeding 0.65. The TMT-B is sensitive to cognitive decline associated with MDD.
Residual Effect on Cognitive Function Measured by Hopkins Verbal Learning Test-Revised (HVLT-R)
The HVLT-R, a measure of verbal learning and memory, is a 12-item word list recall test. Administration includes 3 learning trials, a delayed recall (20-minute) trial, and a 24-word recognition list (including 12 target and 12 foil words). The test administrator reads instructions and word lists aloud, and records words recalled/recognized by the participant. Three learning trials are combined to calculate a total recall score learning, delayed recall, and recognition trials.
Full Information
NCT ID
NCT03796026
First Posted
January 4, 2019
Last Updated
June 9, 2022
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03796026
Brief Title
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, 2-period, Crossover, Sleep Laboratory Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
June 7, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Seltorexant Followed by Placebo
Arm Type
Experimental
Arm Description
Participants will receive seltorexant (40 milligram [mg] capsules) once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive matching placebo orally once daily for 4 consecutive days.
Arm Title
Placebo Followed by Seltorexant
Arm Type
Experimental
Arm Description
Participants will receive placebo once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive seltorexant (40 mg capsules) orally once daily for 4 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Seltorexant 40 mg
Other Intervention Name(s)
JNJ-42847922
Intervention Description
Seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI) Score as Measured by Polysomnography (PSG)
Description
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 Outcome Measure Information:
Title
AHI Score as Measured by PSG
Description
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)
Title
Mean Oxygen Saturation (SpO2) During Total Sleep Time (TST)
Description
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
Title
Mean SpO2 During Rapid Eye Movement (REM), Non-Rapid Eye Movement (NREM), and Awake Stages
Description
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
Title
Percentage of Total Sleep Time with SpO2 less than 90 percent (%), 85%, and 80%
Description
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
Title
Mean Latency to Persistent Sleep (LPS) as Assessed by PSG
Description
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
Title
Wake After Sleep Onset (WASO) by PSG
Description
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
Title
Sleep Efficiency (SE) by PSG
Description
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
Title
Total Sleep Time (TST)
Description
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
Title
Rapid Eye Movement (REM) Sleep Latency
Description
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
Title
Total Duration of Rapid Eye Movement (REM) Sleep
Description
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
Title
NREM Sleep Latency
Description
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
Title
Total Duration of NREM Sleep
Description
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
Title
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
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.
Time Frame
Baseline up to end of study (approximately up to 9 weeks)
Title
Percentage of Participants with all Serious Adverse Events (SAEs) and Events of Special Interest
Description
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. All SAEs and events of special interest including cataplexy (sudden, transient episode of muscle weakness accompanied by conscious awareness), sleep paralysis (the experience of not being able to move, react, or speak when falling asleep/awakening), and complex, sleep-related behaviors/parasomnias such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (Rapid Eye Movement [REM]-associated end-inspiratory apnea/breath holding) will be reported.
Time Frame
Baseline up to end of study (approximately up to 9 weeks)
Title
Number of Participants with Clinically Significant Vital Signs Abnormalities
Description
Number of participants with clinically significant abnormalities in the vital signs including temperature, pulse/heart rate, respiratory rate, and blood pressure will be reported.
Time Frame
Baseline up to end of study (approximately up to 9 weeks)
Title
Number of Participants with Clinically Significant Physical Examination Abnormalities
Description
Number of participants with clinically significant abnormalities in the physical examination including examination of height, body weight, and waist circumference will be reported.
Time Frame
Baseline up to end of study (approximately up to 9 weeks)
Title
Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities
Description
Number of participants with clinically significant abnormalities in the ECG will be reported.
Time Frame
Baseline up to end of study (approximately up to 9 weeks)
Title
Number of Participants with Clinically Significant Laboratory Abnormalities
Description
Blood samples for serum chemistry, hematology, and urinalysis will be collected for clinical laboratory testing.
Time Frame
Baseline up to end of study (approximately up to 9 weeks)
Title
Number of participants with suicidal ideation measured using Columbia Suicide Severity Rating Scale (C-SSRS)
Description
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation indicates an increase in severity of suicidal ideation from baseline.
Time Frame
Baseline, Days 1, 2, 4, 5, and end of study (approximately 9 weeks)
Title
Bond-Lader Visual Analog Scales (B-L VAS) Score
Description
The B-L VAS is a patient-rated scale designed to assess the current level of sedation and consists of sixteen 100-milliliter (mm) VAS anchored by antonyms (Alert-Drowsy, Lethargic-Energetic). Scores are combined to form 3 mood factors: alertness, calmness, and contentedness. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy).
Time Frame
Baseline, Day 2, and Day 5
Title
Next-Day Residual Effect Measured by the Karolinska Sleepiness Scale (KSS) Score
Description
The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a 9-point Likert scale with response options from: 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep).
Time Frame
Baseline, Day 2, and Day 5
Title
Residual Effect on a Cognitive Test Battery Evaluated by Symbol Digit Modalities Test (SDMT)
Description
The SDMT is a widely used, paper-and-pencil assessment of complex scanning and visual tracking, requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The test is viewed as a robust screening test for adult neuropsychological impairment and has been used to demonstrate worse cognitive functioning in patients with MDD. The test includes a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant is presented with randomly ordered symbols and is required to write the number corresponding to each symbol as fast as possible. The number of correct substitutions within 90 seconds is recorded by examiner-administered cognitive test battery.
Time Frame
Baseline and Day 5
Title
Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B)
Description
The TMT-B measures divided attention and executive function (tracking and sequencing). The participant is instructed to draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters (that is, 1-A-2-B). The participant is instructed to work as quickly as possible while still maintaining accuracy. The TMT-B has acceptable reliability; reliability coefficients have typically been reported as exceeding 0.65. The TMT-B is sensitive to cognitive decline associated with MDD.
Time Frame
Baseline and Day 5
Title
Residual Effect on Cognitive Function Measured by Hopkins Verbal Learning Test-Revised (HVLT-R)
Description
The HVLT-R, a measure of verbal learning and memory, is a 12-item word list recall test. Administration includes 3 learning trials, a delayed recall (20-minute) trial, and a 24-word recognition list (including 12 target and 12 foil words). The test administrator reads instructions and word lists aloud, and records words recalled/recognized by the participant. Three learning trials are combined to calculate a total recall score learning, delayed recall, and recognition trials.
Time Frame
Baseline and Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
NeuroTrials Research, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Clinilabs
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
CTI Clinical Trial and Consulting Services
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea
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