Phase 2 N=10 Flumazenil for the Treatment of Primary Hypersomnia
Hypersomnia · Primary Hypersomnia · Idiopathic Hypersomnia
Primary: Change in Psychomotor Vigilance Task (PVT) Median Reaction Time — -9.86; -4.46 msec — p=0.77
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Phase 2 N=23 Clarithromycin for the Treatment of Hypersomnia
Hypersomnia · Idiopathic Hypersomnia · Narcolepsy
Primary: Psychomotor Vigilance Task (PVT) Reaction Time — 279.1; 311.6; 333.8 Msec — p=0.47
Phase 2 N=44 Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia
Idiopathic Hypersomnia · Narcolepsy Without Cataplexy
Primary: Change in Epworth Sleepiness Scale (ESS) Score — 5.0; 4.4 score on a scale
Phase 2 N=95 A Study Of A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Excessive Daytime Sleepiness · Narcolepsy
Primary: Change From Baseline in Maintenance of Wakefulness Test (MWT) Score at Day 21 of Stable Dosing Phase — 6.30; 5.81; 1.29; 1.10 minutes — p=0.418
Phase 1 N=28 A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
Idiopathic Hypersomnia
Primary: Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) — 14.8; 40.0 percentage of participants
Phase 3 N=154 A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
Idiopathic Hypersomnia
Primary: Change in Epworth Sleepiness Scale (ESS) Score — 0.7; 7.4 score on a scale
N/A N=45 A High Density EEG Comparison of Sleep Patterns in Insomnia
Primary Insomnia
Primary: EEG Power During Sleep — 1.40; 1.17 μV^2/Hz — p=0.2791
N/A N=28 Hyper-Arousal in Chronic Primary Insomnia
Chronic Insomnia
Primary: Sympathetic Baroreflex Sensitivity (BRS) Unit — -2.1; -4.3 bursts per 100 heart beats per mm Hg
Phase 4 N=19 Examination of the Effectiveness of Suvorexant in Improving Daytime Sleep in Shift Workers
Sleep Disorder, Shift-Work
Primary: Change in Average Total Sleep Time — 1.83; -0.33 hours/sleep opportunity — p=<0.05
Phase 4 N=13 SWS And Daytime Functioning in Chronic FatiguE Syndrome (SAFFE)
Chronic Fatigue Syndrome
Primary: EEG Slow Wave Activity During Sleep — 0.00002653; 0.00002257 uV^2/Hz
N/A N=32 Metabolomics of Insomnia-Related Hyperarousal
Primary Insomnia
Primary: Number of Metabolites Elevated Relative to the Other Group. — 13; 9 Number of metabolites elevated
N/A N=20 Sleep Loss and Mechanisms of Impaired Glucose Metabolism
Primary Insomnia
Primary: Change in Glucose Tolerance (Kg) in Response to Insulin-modified Intravenous Glucose Tolerance Test — .33; -0.10 %/min, slope of natural log glucose
Phase 2 N=8 Sodium Oxybate in Schizophrenia With Insomnia
Schizophrenia · Insomnia Related to Schizophrenia (307.42)
Primary: Pittsburgh Sleep Quality Index — 6.1 global score — p==0.002
Phase 2 N=30 Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)
Parkinson Disease
Primary: Sleep and Fatigue — 15.6; 9.0; 10.9; 6.6 units on a scale
Phase 4 N=60 Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
Obstructive Sleep Apnea Syndrome
Primary: The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI). — 22.33; 18.18; 21.10; 22.71 Apnea + Hypopnea episodes per hour — p=0.009
N/A N=18 Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
Sleep Apnea · Sleep Disordered Breathing
Primary: Salivary Cortisol Level
N/A N=31 Metabolic Effects of Sleep Extension in People With Obesity
Insulin Resistance · Obesity
Primary: Insulin Sensitivity — -3.8; 0.9 µmol/kgFFM/min
N/A N=210 A Study to Collect Information of People With Narcolepsy in Spain
Narcolepsy
Primary: Percentage of Participants Categorized Based on Treatment by Narcolepsy Type Since Diagnosis up to Study Visit — 5.10; 7.55; 94.90; 92.45 percentage of participants…
N/A N=188 Sleep Without Insomnia or The Use of Chronic Hypnotics
Sleep Initiation and Maintenance Disorders
Primary: Rates of Hypnotic Discontinuation — 64; 52 Participants — p=.039
Phase 3 N=263 Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
Obstructive Sleep Apnea · Sleep Hypopnea
Primary: Maintenance of Wakefulness Test (MWT) — 2.3; -1.3 Minutes — p=0.0003
Phase 2 N=77 Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Parkinson Disease
Primary: Safety Adverse Events — 0; 0; 0; 0 participants
Phase 3 N=28 Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Nocturia · Daytime Sleepiness
Primary: Change From Baseline in Epworth Sleepiness Scale [ESS] — 9.03; 9.73 units on a scale
Phase 4 N=29 Lemborexant Shift Work Treatment Study
Shift-Work Related Sleep Disturbance
Primary: Daytime Total Sleep Time in Minutes Per Day Collected From the Consensus Sleep Diary — 362.7; 365.3 Minutes per day — p=0.884
Phase 3 N=395 Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)
Obstructive Sleep Apnea · Hypopnea
Primary: Maintenance of Wakefulness Test (MWT) — 2.2; 1.7; -1.7 Minutes — p=0.0001
N/A N=92 Sleep IntervEntion as Symptom Treatment for ADHD
ADHD · Sleep · Adolescents
Primary: Sleep Architecture Objective TST [Total Sleep Time] Pre-test to Post-test — 8.11; 7.94; 8.03; 8.07 hours — p=.17
N/A N=107 High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia
Insomnia
Primary: Change From Baseline in Insomnia Severity Index (ISI) — -6.98; -4.94 units on a scale
N/A N=30 Chronic Insomnia and CSF Markers of Dementia
Insomnia Chronic
Primary: CSF Markers Related to Dementia — 4332.1; 4824.0; 393.2; 419.4 picograms per milliliter
Phase 3 N=328 Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Narcolepsy · Sleep Apnea, Obstructive · Sleep Apnea Syndromes
Primary: Safety and Tolerability as Measured by Number of Participants With Adverse Events — 323 Participants
N/A N=89 Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
Insomnia · Primary Insomnia · Chronic Insomnia
Primary: Number of Incorrect Trials During the Computer-administered Attention-Switching Task Test.Attention-Switching Task Latency Error Rate — 5.11; 3.1 trials
N/A N=28 The Psychoneuroimmunology of Insomnia
Primary Insomnia
Primary: Positive Antibody Response — 7; 7 participants