Phase 4 N=24 Treatment of REM Sleep Behavior Disorder (RBD) With Sodium Oxybate
REM Sleep Behavior Disorder · Parkinson Disease
Primary: Number of RBD Episodes in One Month (Per Patient RBD Log) — 37.5; 35.0; 23.5; 25.5 episodes — p=0.03
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=34 Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)
Dementia With Lewy Bodies · REM Sleep Behavior Disorder · Parkinson's Disease Dementia
Primary: Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator. — -1.47; -0.26…
Phase 2 N=82 Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and Controls
Parkinson Disease · REM Sleep Behavior Disorder · Healthy
Primary: Change in Sensitivity of QSM MR Imaging From Baseline MR Imaging to 24 Month MR Imaging — 379.5896; 314.1832; 561.1894; 288.1832 ppb — p=0.66
N/A N=40 Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans
Non PTSD · PTSD
Primary: Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose — 3.78; 3.76; 3.52; 3.36 Z values — p=<0.001
Phase 3 N=30 Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone
Parkinson's Disease · Insomnia
Primary: TST — 5.7; 6.0 hours
N/A N=38 Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease
Parkinson's Disease · Sleep Disordered Breathing
Primary: Tests to Determine the Apnea-hypopnea Index (Number of Apneas and Hypopneas Per Hour of Sleep) — 5.2; 20 apnea hypopnea index
Phase 2 N=36 Apnea and Insomnia Relief Study
Sleep Apnea Syndromes · Insomnia Disorder · Stress Disorders, Post-Traumatic
Primary: World Health Organization Quality of Life (WHOQOL-BREF) — 11.26; 9.75; 12.78; 10.84 units on a scale
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
Phase 2 N=15 Role of Mirtazapine in Ameliorating Sleep Disordered Breathing
Spinal Cord Injuries · Sleep Disordered Breathing
Primary: CO2 Reserve (Delta-PETCO2-AT) — -3.8; -2.0 mmHg — p=0.015
Phase 3 N=85 Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
Restless Legs Syndrome
Primary: Wake After Sleep Onset (WASO) — 51.50; 78.42; 78.60 minutes — p=<0.0001
N/A N=92 Determinants of Age Related Breathing Instability During Non-Rapid-Eye-Movement (NREM) Sleep
Sleep Apnea · Age
Primary: Apneic Threshold (AT) and Carbon-dioxide (CO2) Reserve — 39.8; 36.7; -4.1; -2.6 mm Hg — p=<0.05
Phase 3 N=44 Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder
Sleep Disturbances
Primary: Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters — -24.9; -19.7; -26.4; 49.0 minutes (min)
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
Early Phase 1 N=34 Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Sleep-Related Eating Disorder
Primary: Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline) — -41.2; -20.0 change in % of nights eating per week
Phase 4 N=50 Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder
Seasonal Affective Disorder
Primary: Sleep Satisfaction at Baseline and Measured Monthly, as Measured by the Pittsburgh Sleep Quality Index (PSQI) — 11.56; 11.45; 9.52; 8.67 scores on a scale
Phase 4 N=34 Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia
Restless Legs Syndrome · Insomnia · Sleep Disorder
Primary: Actigraphically-Derived Total Sleep Time — 5.03; 11.44; 7.60; 17.96 Minutes
Phase 2 N=244 BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
Excessive Daytime Sleepiness · Parkinson Disease
Primary: Measurement of Sleepiness Using the Epworth Sleepiness Scale (ESS) at Baseline and Post Dose. — -4.34; -4.64; -3.46; -4.73 units on a scale — p=0.668
Phase 3 N=30 A Sleep Laboratory Study to Investigate the Safety and Efficacy of the Rotigotine Skin Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis
Restless Legs Syndrome · End-Stage Renal Disease
Primary: Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI) — 1.16; 0.51 ratio — p=0.0232
Phase 3 N=136 Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance
Restless Legs Syndrome · Restless Legs Syndrome (RLS)
Primary: Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward…
Phase 4 N=79 Improving Sleep in Nursing Homes
Sleep Deprivation
Primary: Number of Participants Meeting Good Sleep Latency Criteria — 7; 6 participants — p=0.655
Phase 4 N=81 Effects of Neupro on Cardiovascular Observations in Patients With Restless Legs Syndrome
Restless Legs Syndrome
Primary: Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of…
N/A N=15 Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Primary: Feasibility of Recruitment and Retention — 8; 6; 8; 6 participants
N/A N=54 Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)
Insomnia · Depression · Posttraumatic Stress Disorder
Primary: Columbia Suicide Severity Rating Scale (C-SSRS) — 5.4; 8.4 units on a scale — p=.153
N/A N=38 Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Delirium
Primary: Association Between Sleep and POD — 278.5; 313.5 Minutes
Phase 2 N=7 The Effect of Donepezil (Aricept(Registered Trademark)) on REM Sleep in Children With Autism
Autism · Cognition Disorder
Primary: Change in Percentage of Time That Subjects With Autism Spend in REM Sleep. — 9.2 percentage of REM sleep
Phase 2 N=63 Study of Lemborexant for Irregular Sleep-Wake Rhythm Disorder and Mild to Moderate Alzheimer's Disease Dementia
Irregular Sleep-Wake Rhythm Disorder
Primary: Core Phase: Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment — 76.34; 77.64; 78.45; 76.38…
Phase 4 N=8 Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Insomnia · Spinal Cord Injury · Tetraplegia
Primary: Amount of Wakefulness After Sleep Onset (WASO) — 72.3; 76.5 Minutes — p=0.70
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=12 Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs
Insomnia
Primary: Auditory Awakening Threshold — 74.17; 83.75; 79.17 decibels (db)
N/A N=154 Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes
Menopause
Primary: Diary Based Sleepiness — 5.01; 5.13; 4.87; 4.72 score on a scale