344 Daridorexant Improves Total Sleep Time (TST) in Insomnia Patients Without Altering the Proportion of Sleep Stages

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A137-A138
Author(s):  
Gary Zammit ◽  
David Mayleben ◽  
Ingo Fietze ◽  
Scott Pain ◽  
Dalma Seboek Kinter ◽  
...  
Keyword(s):  
Sleep Stage ◽  
Oral Treatment ◽  
Sleep Time ◽  
Sleep Stages ◽  
Dependent Manner ◽  
Treatment Change ◽  
Pivotal Phase ◽  
Double Blind ◽  
Treatment Groups ◽  
Sleep Parameters

Abstract Introduction Daridorexant, a new dual orexin receptor antagonist, improved sleep parameters and daytime functioning in two pivotal Phase 3 trials in patients with insomnia (Trial-1, NCT03545191; Trial-2, NCT03575104); polysomnography data were collected at multiple timepoints from >1,800 patients. We report the effects of daridorexant on TST and sleep stages from both trials. Methods Eligible patients with insomnia (according to DSM-5) were randomized (1:1:1) in Trial-1 (N=930) to daridorexant 25mg, 50mg, or placebo and in Trial-2 (N=924) to daridorexant 10mg, 25mg, or placebo. Oral treatment was administered each night during a 3-month double-blind treatment period. Assessment of TST and sleep stages (non-rapid eye movement [NREM, N]1, N2, N3, REM), measured by polysomnography in sleep laboratory, was performed on two consecutive nights during single-blind placebo run-in (baseline) and Months 1 and 3 (M1 and M3) of double-blind treatment. Change from baseline in TST and sleep stages were exploratory endpoints in both trials. Data for M3 (mean ± standard deviation) are presented as change from baseline. Results Daridorexant dose-dependently increased TST(minutes) from baseline to M3, more than placebo, in Trial-1 (25mg, 55±56; 50mg, 61±53; placebo, 40±56) and Trial-2 (10mg, 37±57; 25mg, 50±53; placebo, 35±56). In both trials, sleep stage proportions were preserved from baseline to M3, with no relevant changes in any group. Baseline time spent in each sleep stage (% of TST) was consistent across groups in both trials (range across treatment groups in both trials: N1:11–13; N2:55–57; N3:11–14; REM:19–20). In Trial-1 (25mg/50mg/placebo), the change from baseline to M3 in % of TST spent in N1(-0.3±4.7/-0.2±5/0.1±5), N2(2±8/1±7/1±7), N3(-2±6/-2±6/-2±6), and REM(1±6/1±5/1±5) was low and numerically similar across treatments. In Trial-2, the change from baseline to M3 in % of TST spent in each sleep stage was consistent with Trial-1, with no effect of dose. Mean changes from baseline (% of TST) for each sleep stage appeared to be independent from increasing TST. Data for 25mg were consistent between trials. Conclusion Daridorexant at any dose, and each more than placebo, increased TST in a dose-dependent manner without affecting the proportion of all sleep stages in patients with insomnia. Support (if any) Funded by Idorsia Pharmaceuticals Ltd.

scholarly journals Glucocorticoid Replacement Is Permissive for Rapid Eye Movement Sleep and Sleep Consolidation in Patients with Adrenal Insufficiency1

2000 ◽  
Vol 85 (11) ◽  
pp. 4201-4206
Author(s):  
Diego GarcÍa-Borreguero ◽  
Thomas A. Wehr ◽  
Oscar Larrosa ◽  
Juan J. Granizo ◽  
Donna Hardwick ◽  
...  
Keyword(s):  
Rem Sleep ◽  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Stages ◽  
Sleep Regulation ◽  
Double Blind ◽  
Rem Latency ◽  
Sleep Parameters ◽  
Sleep Consolidation ◽  
Permissive Role

There is a well described temporal relation between hormonal secretion and sleep phase, with hormones of the hypothalamic-pituitary-adrenal (HPA) axis possibly playing a role in determining entry into and duration of different sleep stages. In this study sleep features were studied in primary Addison’s patients with undetectable levels of cortisol treated in a double blind, randomized, cross-over fashion with either hydrocortisone or placebo supplementation. We found that REM latency was significantly decreased in Addison’s patients when receiving hydrocortisone at bedtime, whereas REM sleep time was increased. There was a trend toward an increase in the percentage of time in REM sleep and the number of REM sleep episodes. Waking time after sleep onset was increased, whereas no differences were observed between the two conditions when total sleep time or specific non-REM sleep parameters were evaluated. Our results suggest that in Addison’s patients, cortisol plays a positive, permissive role in REM sleep regulation and may help to consolidate sleep. These effects may be mediated either directly by the central effects of glucocorticoids and/or indirectly through CRH and/or ACTH.

scholarly journals On the influence of the day of the week on objective and self-rated sleep quality of adults

2020 ◽  
Author(s):  
C. Sauter ◽  
H. Dorn ◽  
H. Danker-Hopfe
Keyword(s):  
Sleep Quality ◽  
Adult Population ◽  
Analysis Data ◽  
Sleep Time ◽  
Base Station ◽  
Double Blind ◽  
Sleep Parameters ◽  
A Cell ◽  
Day Of The Week

Abstract Background and objective The extent to which adult sleep varies depending on the day of the week has not yet been systematically investigated with electroencephalography (EEG) data. Whether such effects exist and whether they are related to age, gender, and employment status was retrospectively analyzed based on data from an experimental double-blind cross-over study in which effects of electromagnetic fields of a cell phone base station on the sleep of a general rural population had been examined. Methods The sleep of 397 adults (age 45.0 ± 14.2 years, range 18–81 years; 50.9% women) from ten different rural German villages was recorded for 12 nights with ambulatory devices. Self-reported sleep quality was recorded in morning and evening protocols. Friedman tests were used for statistical analysis of the comparison between the days, and the Kruskal–Wallis and Mann–Whitney U tests were used for pairwise comparisons of independent parameters between groups. Results For the present analysis, data from 335 participants were considered. Overall, the differences between nights were small and the quality of sleep was good. Three of the five objective and all six self-rated sleep parameters differed significantly between the days of the week. While the objective and the self-estimated total sleep time were longest on Sunday nights, the qualitatively poorest values occurred on Monday nights. People who worked fulltime had the longest sleep latencies on Sunday nights. Friday nights were rated the best. Conclusion The objective and self-rated sleep quality varied relatively little in a rural adult population over the course of the week, being worst on Monday nights and best on Friday nights.

The Efficacy and Safety of Tanacetum Parthenium (Feverfew) in Migraine Prophylaxis—a Double-Blind, Multicentre, Randomized Placebo-Controlled Dose-Response Study

Cephalalgia ◽  
2002 ◽  
Vol 22 (7) ◽  
pp. 523-532 ◽  
Author(s):  
V Pfaffenrath ◽  
HC Diener ◽  
M Fischer ◽  
M Friede ◽  
HH Henneicke-von Zepelin
Keyword(s):  
Dose Response ◽  
Baseline Period ◽  
Dependent Manner ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Treatment Groups ◽  
Tanacetum Parthenium ◽  
Number Of Patients ◽  
Significant Difference ◽  
Efficacy Parameter

Tanacetum parthenium (feverfew), is a well-known herb for the prophylactic treatment of migraine. The primary objective was to show a dose-response of a new stable extract (MIG-99) reproducibly manufactured with supercritical CO2 from feverfew ( T. parthenium). Furthermore, the study should provide data on the safety and tolerability of MIG-99. In a randomized, double-blind, multicentre, controlled trial with an adaptive design, the clinical efficacy and safety of three dosages of MIG-99 (2.08 mg; 6.25 mg; 18.75 mg t.i.d.) were compared with placebo. The patients ( n = 147) suffered from migraine with and without aura according to International Headache Society (IHS) criteria and were treated with one of the study medications for 12 weeks after a 4-week baseline period. The primary efficacy parameter was the number of migraine attacks during the last 28 days of the treatment period compared with baseline. Secondary endpoints were total and average duration and intensity of migraine attacks, mean duration of the single attack, number of days with accompanying migraine symptoms, number of days with inability to work due to migraine as well as type and amount of additionally taken medications for the treatment of migraine attacks. The design of the study included a pre-planned adaptive interim analysis for patients with at least four migraine attacks within the baseline period. With respect to the primary and secondary efficacy parameter, a statistically significant difference was not found between the overall and the confirmatory intention-to-treat (ITT) sample in the exploratorily analysed four treatment groups. The frequency of migraine attacks for the predefined confirmatory subgroup of patients ( n = 49) with at least four migraine attacks during the baseline period decreased in a dose-dependent manner ( P = 0.001). The highest absolute change of migraine attacks was observed under treatment with 6.25 mg t.i.d. (mean ± SD = x1.8 ± 1.5 per 28 days) compared with placebo (-0.3 ± 1.9; P = 0.02). Overall, 52 of 147 (35%) patients reported at least one adverse event (AE). The incidence of AEs in the active treatment groups was similar to that in the placebo group, and no dose-related effect was observed in any safety parameter. MIG-99 failed to show a significant migraine prophylactic effect in general. Accordingly, in the ITT analysis a dose-response relationship could not be observed. MIG-99 was shown to be effective only in a small predefined subgroup of patients with at least four attacks during the 28-day baseline period where the most favourable benefit-risk ratio was observed with a dosage of three capsules of 6.25 mg MIG-99 extract per day. Because of the low number of patients, these findings need to be verified in a larger sample. The incidence of AEs was similar for all treatment groups.

SLEEP PATTERNS IN PRE-ADOLESCENT CHILDREN: AN EEG-EOG STUDY

PEDIATRICS ◽  
1968 ◽  
Vol 42 (2) ◽  
pp. 324-335 ◽  
Author(s):  
John J. Ross ◽  
Harman W. Agnew ◽  
Robert L. Williams ◽  
Wilse B. Webb
Keyword(s):  
Total Sleep Time ◽  
Sleep Stage ◽  
Sleep Time ◽  
Sleep Pattern ◽  
Adolescent Male ◽  
Sleep Stages ◽  
Night Sleep ◽  
Sleep Patterns ◽  
Unequal Distribution ◽  
Older Subjects

The typical all-night sleep pattern of the pre-adolescent male was determined by analyzing the simultaneous EEG-EOG tracings of 18 healthy schoolboys (range 8 to 11 years). The sleep patterns of these boys resembled that of older subjects by the occurrence of a more or less orderly sequence of sleep stages which spontaneously shifted from one stage to another. Stability of the pattern for a given boy was observed in the consistent amount of time spent in each sleep stage and in the number of sleep stage changes night after night. When compared with the adult sleep patterns, pre-adolescent total sleep time was 2½ hours longer with unequal distribution of the added time to each of the sleep stages. Sleep stages in children are longer in duration than in adults, and the sleep patterns are as stable as that of the adult.

Investigation of chronic venous insufficiency in patients with sleep disorders due to restless legs syndrome

2020 ◽  
Vol 35 (10) ◽  
pp. 771-776
Author(s):  
Atıf Yolgösteren ◽  
Leyla Köse Leba ◽  
Aylin Bican Demir
Keyword(s):  
Sleep Disorder ◽  
Restless Legs Syndrome ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Sleep Stage ◽  
Sleep Time ◽  
Sleep Stages ◽  
Restless Legs ◽  
Group 2 ◽  
Group 1

Background We aimed to investigate of chronic venous insufficiency on patients with sleep disorder due to restless legs syndrome. Method Five hundred forty-one cases on whom polysomnography was performed due to sleep disorder were evaluated retrospectively. Forty patients with restless legs syndrome were determined. They were examined by history, physical examination, and duplex ultrasonography in terms of chronic venous insufficiency. The sleep stage rates of both groups were compared (that the rate of total sleep time in polysomnography to sleep stages is expressed as minute and percentage has been defined as sleep stage rate). Result Chronic venous insufficiency was identified in 20 out of 40 patients (group 1; female, 90%). In group 2, there were patients with only restless legs syndrome but with no chronic venous insufficiency (female, 80%). The mean ages of both groups were 56.4 ± 11.8 and 54.3 ± 14.7 years. Stage 1 sleep rate in group 1 was 5% ± 2.7 and in group 2 was 8% ± 3.8 (p = 0.006). Periodic limb movement index (polysomnography finding evaluating involuntary leg movements during sleep) was 11.4 ± 17.5 in group 1, and it was 29.4 ± 37.9 in group 2 (p = 0.006). Conclusion We recommend that chronic venous insufficiency should be investigated in patients with primary restless legs syndrome diagnosis.

Cluster headache shows no association with rapid eye movement sleep

Cephalalgia ◽  
2012 ◽  
Vol 32 (4) ◽  
pp. 289-296 ◽  
Author(s):  
Sebastian Zaremba ◽  
Dagny Holle ◽  
Thomas E Wessendorf ◽  
Hans C Diener ◽  
Zaza Katsarava ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Eye Movement ◽  
Rem Sleep ◽  
Sleep Stage ◽  
Sleep Time ◽  
Brain Regions ◽  
Sleep Stages ◽  
Rapid Eye Movement ◽  
Sleep State ◽  
Wake Time

Background: The connection of cluster headache (CH) attacks with rapid eye movement (REM) sleep has been suggested by various studies, while other authors challenge this assumption. We performed serial polysomnography to determine the association of nocturnal CH attacks and sleep. Methods: Five patients diagnosed with CH (two with the episodic and three with the chronic subtype) were included and studied over four consecutive nights to evaluate connections between attacks onset and sleep stage. Results: Twenty typical CH attacks were reported. Thirteen of these attacks arose from sleep. Seven attacks were reported after waking in the morning or shortly before going to sleep. The beginnings of sleep-related attacks were distributed arbitrarily between different non-REM sleep stages. No association of CH attacks with REM or sleep disordered breathing was observed. Increased heart rate temporally associated with transition from one sleep state to another was observed before patients awoke with headache. Total sleep time, total wake time, arousal index and distribution of non-REM sleep stages were different between chronic and episodic CH. Conclusion: CH attacks are not associated with REM sleep. Brain regions involved in sleep stage transition might be involved in pathophysiology of CH. Differences in sleep characteristics between subgroups might indicate adaptation processes or underlying pathophysiology.

Is trazodone more effective than clomipramine in major depressed outpatients? A single-blind study with intravenous and oral administration

CNS Spectrums ◽  
2017 ◽  
Vol 24 (02) ◽  
pp. 258-264 ◽  
Author(s):  
Massimiliano Buoli ◽  
Chiara Rovera ◽  
Sara Maria Pozzoli ◽  
Alessio Fiorentini ◽  
Laura Cremaschi ◽  
...  
Keyword(s):  
Oral Administration ◽  
Clinical Judgment ◽  
Rating Scale ◽  
Oral Treatment ◽  
Statistical Significance ◽  
Double Blind ◽  
Treatment Groups ◽  
Potential Benefits ◽  
Hamilton Anxiety Rating Scale ◽  
Intravenous And Oral Administration

ObjectiveSome antidepressants, such as trazodone or clomipramine, can be administered intravenously in patients with major depressive disorder (MDD), with potential benefits compared to the standard oral treatment, but available data about their efficacy are limited. The present study was aimed to compare the effectiveness of trazodone and clomipramine (intravenous [i.v.] followed by oral administration).MethodsSome 42 patients with a diagnosis of MDD according to the DSM–5 were selected and treated with i.v. trazodone or clomipramine according to clinical judgment. The Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, and the Montgomery-Åsberg Depression Rating Scale were administered at baseline, after 2 weeks, and after 6 weeks, as well as after 1 week of intravenous antidepressant administration. Raters were blinded to type of treatment.ResultsNo significant differences were found between treatment groups in terms of effectiveness at endpoint. Borderline statistical significance was found in terms of number of responders in favor of trazodone. In addition, patients treated with trazodone reported fewer total side effects than those treated with clomipramine.ConclusionBoth i.v. trazodone and clomipramine are rapid and effective options for improving depressive symptoms, although trazodone appears to be tolerated better. Further studies with larger samples and double-blind conditions are warranted to confirm our results.

scholarly journals Sleep Stage Estimation from Bed Leg Ballistocardiogram Sensors

Sensors ◽  
2020 ◽  
Vol 20 (19) ◽  
pp. 5688
Author(s):  
Yasue Mitsukura ◽  
Brian Sumali ◽  
Masaki Nagura ◽  
Koichi Fukunaga ◽  
Masato Yasui
Keyword(s):  
Mathematical Model ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Template Matching ◽  
Graphical Representation ◽  
Sleep Stage ◽  
Ground Truth ◽  
Sleep Time ◽  
Prediction Algorithm ◽  
Sleep Stages

Ballistocardiogram (BCG) is a graphical representation of the subtle oscillations in body movements caused by cardiovascular activity. Although BCGs cause less burden to the user, electrocardiograms (ECGs) are still commonly used in the clinical scene due to BCG sensors’ noise sensitivity. In this paper, a robust method for sleep time BCG measurement and a mathematical model for predicting sleep stages using BCG are described. The novel BCG measurement algorithm can be described in three steps: preprocessing, creation of heartbeat signal template, and template matching for heart rate variability detection. The effectiveness of this algorithm was validated with 99 datasets from 36 subjects, with photoplethysmography (PPG) to compute ground truth heart rate variability (HRV). On average, 86.9% of the inter-beat intervals were detected and the mean error was 8.5ms. This shows that our method successfully extracted beat-to-beat intervals from BCG during sleep, making its usability comparable to those of clinical ECGs. Consequently, compared to other conventional BCG systems, even more accurate sleep heart rate monitoring with a smaller burden to the patient is available. Moreover, the accuracy of the sleep stages mathematical model, validated with 100 datasets from 25 subjects, is 80%, which is higher than conventional five-stage sleep classification algorithms (max: 69%). Although, in this paper, we applied the mathematical model to heart rate interval features from BCG, theoretically, this sleep stage prediction algorithm can also be applied to ECG-extracted heart rate intervals.

scholarly journals 1197 Utility of Fitbit Charge 2 for Sleep Monitoring in Patients With Obstructive Sleep Apnea

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A458-A458
Author(s):  
D Kim ◽  
W Shin ◽  
J Byun
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Total Sleep Time ◽  
Sleep Stage ◽  
Sleep Time ◽  
Wearable Devices ◽  
Sleep Stages ◽  
Sleep Monitoring ◽  
Obstructive Sleep ◽  
Single Center Observational Study

Abstract Introduction The wearable device may be useful in monitoring sleep. Many studies reported reliable data in detecting sleep-wake states and sleep stage proportion in healthy adults, However, only a few validation studies were performed evaluating sleep using the wearable devices in patients with obstructive sleep apnea(OSA), which showed insufficient accuracy. We aimed to evaluate the reliability of multi-sensory wristband (Fitbit Charge 2) in patients with OSA. Methods This was a preliminary analysis of a prospective single-center observational study. Consecutive patients underwent standard Polysomnography (PSG) for evaluation of OSA with Fitbit Charge 2. Sleep data from PSG and Fitbit charge 2 were compared using paired t-tests and Bland-Altman plots. Results A total of eighty-six patients were analyzed. Four of them had poor data quality, 18 of them did not show sleep stages. Compared with the PSG, Fitbit Charge 2 showed higher total sleep time (419.1±194.0 vs 269.8±22.6, p<0.001) and sleep efficiency (95.8±2.5 vs 84.6±7.1, p<0.001). Those with sleep stage data showed higher sleep efficacy (87.7±5.5 vs 82.37.5, p=0.024) and a lower proportion of N1 sleep (33.7±19.9 vs 65.3±38.8, p=0.01). Conclusion Fitbit Charge 2 showed limited utility in monitoring sleep in patients with obstructive sleep apnea. Support none

ACUTE OTITIS MEDIA: TREATMENT RESULTS IN RELATION TO BACTERIAL ETIOLOGY

PEDIATRICS ◽  
1969 ◽  
Vol 43 (3) ◽  
pp. 351-358
Author(s):  
B. W. Nilson ◽  
Ronald L. Poland ◽  
Robert S. Thompson ◽  
David Morehead ◽  
Alice Baghdassarian ◽  
...  
Keyword(s):  
Otitis Media ◽  
Oral Treatment ◽  
Acute Otitis Media ◽  
Double Blind ◽  
Treatment Groups ◽  
Treatment Regimens ◽  
Penicillin V ◽  
Blood Assay ◽  
Number Of Patients ◽  
Blind Manner

Three hundred and six children less than 3 years of age with acute otitis media were randomly distributed among three oral treatment regimens: penicillin V, penicillin V plus sulfonamide, and ampicillin. Treatment groups were comparable when analyzed for the number of patients with fever at onset and the proportion shown to be taking the antibiotic by blood assay. Response was determined in a double blind manner and correlated with the organism isolated from the middle ear aspirate. Results both for pneumococcal otitis and for all otitis regardless of culture were not significantly different with the three regimens. However, the groups with H. influenzae otitis treated with either penicillin plus sulfonamide or ampicillin had a better therapeutic response than those treated with penicillin V alone. Patients receiving ampicillin generally achieved a bacteriostatic serum level for strains of H. influenzae isolated by tympanocentesis while patients receiving penicillin V generally did not achieve such a level.

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