The primary purpose of this study is to investigate the effect of JNJ-42847922 (change versus placebo) on sleep efficiency (SE) measured by polysomnography (PSG) after single and multiple dose administration to participants with insomnia disorder without psychiatric comorbidity.
This is a multi-center, randomized (study medication assigned to participants by chance), placebo-controlled, double-blind (neither physician nor participant knows the identity of the assigned treatment), 2-way cross-over study of JNJ-42847922 participants with insomnia disorder without psychiatric comorbidity. The study consists of following phases: screening (28 days prior to Day 1), a double-blind treatment phase (consists of 5-day treatments, either JNJ-42847922 or placebo in subsequent 2-treatment periods, each separated with washout period of 5 to 9 days), and a follow-up examination (7 to 14 days after last dose administration). Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Participants in arm JNJ-42847922 then Placebo will receive 2\*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 1 and participants in arm Placebo then JNJ-42847922 will receive 2\*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 2.
Participants in arm JNJ-42847922 then Placebo will receive matching Placebo orally once daily from Day 1 to Day 5 in Period 2 and participants in arm Placebo then JNJ-42847922 will receive matching placebo orally once daily from Day 1 to Day 5 in Period 1.
Unnamed facility
Hollywood, Florida, United States
Unnamed facility
Berlin, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Schwerin, Germany
Unnamed facility
Leiden, Netherlands
Sleep Efficiency by Polysomnography
The total sleep time divided by the total time in bed (that is, the number of minutes from the beginning of the Polysomnography recording to the end of the recording).
Time frame: up to Night 5
Total Sleep Time by Polysomnography
All of the minutes of Stages 1, 2, 3/4 Non Rapid Eye-Movement (NREM) and Rapid-Eye-Movement (REM) sleep, as measured by Polysomnography, are summed to determine the Total Sleep Time.
Time frame: up to Night 5
Wake Time After Sleep Onset by Polysomnography
The number of minutes in the Awake stage after the onset of persistent sleep to the end of the recording.
Time frame: up to Night 5
Number of Awakenings After Persistent Sleep by Polysomnography
Number of Awakenings is defined as the number of times after the onset of persistent sleep that there is a wake entry of at least 2 epochs in duration. Each entry must be separated by Stage 2, 3/4 NREM sleep or REM sleep in order to be counted.
Time frame: up to Night 5
Total Time Spent in Deep Sleep by Polysomnography
Duration of slow wave sleep will be reported.
Time frame: up to Night 5
Mean Latency to Persistent Sleep by Polysomnography
Elapsed time from the beginning of the Polysomnography recording to the onset of the first 10 minutes of continuous sleep will be measured over 2 nights and the average time to sleep will be calculated.
Time frame: up to Night 5
Leeds Sleep Evaluation Questionnaire (LSEQ) Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The LSEQ is a participant-reported 10-item visual analogue scale score used to rate the quality of sleep and to assess changes in sleep quality over the course of treatment.
Time frame: up to Night 5
Subjective assessment of sleep by Questionnaire
Subjective assessment of sleep parameters will be assessed by following questions to indicate how much and how well participant slept during the past night: 1. How long did it take you to fall asleep for the first time (Mean Subjective sleep onset latency); 2. How long have you slept in total (Total sleep time); 3. How long were you awake after initial sleep onset until you finally got out of bed (Wake After Sleep Onset); 4. How often did you awake during the night (how many times); 5. How did you rate the quality of the night sleep (1= extremely bad 10 =excellent).
Time frame: up to Night 5
Next Morning Residual Effects by Bond and Lader Visual Analogue Scale
The Bond and Lader Visual Analogue Scale consists of sixteen 100 mm visual analog scales anchored by antonyms (example, Alert-Drowsy, Lethargic-Energetic, etc). Scores will be combined to form three mood factors: alertness, calmness, and contentedness.
Time frame: up to Night 5
Next Morning Residual Effects by cognitive test battery
Time frame: up to Night 5
Next Morning Residual Effects by Karolinska Sleepiness Scale
The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep (9).
Time frame: up to Night 5
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (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: up to Night 5