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
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=110 A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause
Sleep Disturbances Associated With Menopause
Primary: Change From Baseline in Wakefulness After Sleep Onset (WASO) at Week 4 as Measured by Polysomnography (PSG) — -23.50; -1.01 Minutes
Phase 4 N=29 Impact of Hot Flashes on Sleep and Mood Disturbance
Menopause · Depression · Hot Flashes
Primary: Percent Change in Wake After Sleep Onset (WASO) — 62 percent change — p=0.007
Phase 4 N=41 Menopausal Sleep Fragmentation and Body Fat Gain
Menopause
Primary: Normalized Serum Leptin Levels — 96.7; 94.0; 90.0; 101.0 percentage of mean baseline leptin — p=0.22
Phase 4 N=34 Estrogen Variability and Irritability During the Menopause Transition
Menopause · Irritable Mood
Primary: Mean IDAS Ill Temper Scale Score Over Time — 6.19; 6.02 score on a scale — p=0.09
Phase 4 N=60 Efficacy of Suvorexant in the Treatment of Hot Flash-associated Insomnia
Insomnia
Primary: Within-person Change in ISI Score — -8.1; -5.6 score on a scale
N/A N=32 Gabapentin for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women
Menopause · Hot Flashes · Vasomotor Disturbance
Primary: Tolerability of Gabapentin — 22; 4 Participants
N/A N=38 Reducing the Experience of Menopausal Symptoms Through Temperature
Hot Flashes · Menopause
Primary: Hot Flash Diary — 9 number of hot flashes per week
Phase 3 N=189 Progesterone for Perimenopausal Night Sweats
Hot Flushes · Night Sweats
Primary: Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks — 5.5; 7.1 Units of Vasomotor Symptom Score
N/A N=28 The Psychoneuroimmunology of Insomnia
Primary Insomnia
Primary: Positive Antibody Response — 7; 7 participants
Phase 4 N=31 Treating Insomnia and Improving Metabolic Health in Midlife Women With Insomnia
Insomnia · Metabolic Health · Menopause
Primary: Change From Baseline in Insomnia Severity Index (ISI) Score at 4 Weeks — 14.6; 14.5; -5.8; -2.7 units on a scale — p=0.04
Phase 1 N=19 Melatonin Osteoporosis Prevention Study
Osteoporosis · Osteopenia
Primary: The Effect of Melatonin (3 mg) or Placebo on the Mean Change in Serum Osteocalcin (OC) Levels in Women After 6 Months, as Compared to Baseline — -0.6; 1.83 ng/mL
N/A N=149 Insomnia Treatment for Women Veterans
Insomnia
Primary: Number of Participants Completing 5 Behavioral Treatment Sessions — 63; 70 Participants — p==.120
Phase 4 N=19 The Effects of Milnacipran on Sleep Disturbance in Fibromyalgia
Sleep Disorders · Fibromyalgia · Sleep
Primary: Number of Awakenings After Sleep Onset (NAASO) — 39.5; 34.9 Awakenings — p=0.424
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=100 Mechanisms of Sleep Disruption Hyperalgesia
Sleep Deprivation · Pain
Primary: Spinal Sensitization as Assessed by Area of Secondary Hyperalgesia (2HA) After Two Nights of Uninterrupted Sleep and Two Nights of 8 Forced Awakenings — 1276.25…
N/A N=61 Sex Steroids, Sleep, and Metabolic Dysfunction in Women
Polycystic Ovary Syndrome (PCOS) · Obstructive Sleep Apnea · Obesity
Primary: Very-Low Density Lipoprotein-Triglyceride (VLDL-TG) Secretion Rate — 3.13; 2.03; 4.66; 3.36 umol/min/L plasma — p=0.85
N/A N=6 Effects of Estrogen Deficiency on Energy Expenditure
Obesity
Primary: Brown Adipose Tissue Activity — 3.9; 4.0 Standard uptake value (SUV) — p=0.84
Phase 4 N=20 Understanding Experimentally Induced Hot Flushes
Hot Flashes
Primary: Percent Change in Objective Sleep Efficiency — -2.6; 4.2 percent change
N/A N=30 Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses
Nocturia · Hypertension · Sleep Disturbance
Primary: Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention — -0.4; 7.3; 3.9 percentage of daytime mean SBP — p=0.65
N/A N=59 Pharmacotherapy and Mechanisms of Sleep Disturbance in Alcohol Dependence
Alcohol Dependence · Insomnia
Primary: Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent) — 51.3; 53.8; 50.2; 59.6 percentage of total sleep time
N/A N=92 Improving Sleep Using Mentored Behavioral and Environmental Restructuring
Insomnia
Primary: Sleep Efficiency (SE) — 76.1 percentage of time in bed
N/A N=22 Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study
Posttraumatic Stress Disorder · Insomnia
Primary: Insomnia Severity — 21.58; 12.45 ISI Score
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
N/A N=56 Impact of Behavioral Treatment of Insomnia on Nighttime Urine Production
Sleep Fragmentation · Poor Quality Sleep · Nocturia
Primary: Change in Nocturnal Polyuria Index — 41.7; 41.7; 34.5; 37.8 percentage of urine volume — p=0.3
N/A N=187 Hypnosis For Hot Flashes Among Postmenopausal Women in a Randomized Clinical Trial
Hot Flashes
Primary: Hot Flash Frequency — 27.19; 68.26; 19.44; 62.32 hot flashes per week
N/A N=111 Magnesium Nutrition and Sleep Behavior in Older Adults
Nutritional Deficiency · Insomnia
Primary: Global Pittsburgh Sleep Quality Index — 6.30; 6.96 score on a scale
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=27 Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Post-Traumatic Stress Disorders
Primary: Short PTSD Rating Interview (SPRINT) — 16.13; 19.88 units on a scale
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