scholarly journals Randomized Double-Blind Controlled Trial on the Effect of Proteins with Different Tryptophan/Large Neutral Amino Acid Ratios on Sleep in Adolescents: The PROTMORPHEUS Study

Nutrients ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1885 ◽  
Author(s):  
Oussama Saidi ◽  
Emmanuelle Rochette ◽  
Éric Doré ◽  
Freddy Maso ◽  
Julien Raoux ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Dietary Intake ◽  
Sleep Disturbances ◽  
Controlled Trial ◽  
Internal Clock ◽  
Sleep Efficiency ◽  
Large Neutral Amino Acid ◽  
Double Blind ◽  
Circadian Phase ◽  
Two Samples

Disturbed sleep is common in adolescents. Ingested nutrients help regulate the internal clock and influence sleep quality. The purpose of this clinical trial is to assess the effect of protein tryptophan (Trp)/large neutral amino acids (LNAAs) ratio on sleep and circadian rhythm. Ingested Trp is involved in the regulation of the sleep/wake cycle and improvement of sleep quality. Since Trp transport through the blood–brain barrier is competing with LNAAs, protein with higher Trp/LNAAs were expected to increase sleep efficiency. This randomized double-blind controlled trial will enroll two samples of male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24). They will take part randomly in three sessions each held over a week. They will undergo a washout period, when dietary intake will be calibrated (three days), followed by an intervention period (three days), when their diet will be supplemented with three proteins with different Trp/LNAAs ratios. Physical, cognitive, dietary intake, appetite, and sleepiness evaluations will be made on the last day of each session. The primary outcome is sleep efficiency measured through in-home electroencephalogram recordings. Secondary outcomes include sleep staging, circadian phase, and sleep-, food intake-, metabolism-, and inflammation-related biochemical markers. A fuller understanding of the effect of protein Trp/LNAAs ratio on sleep could help in developing nutritional strategies addressing sleep disturbances.

scholarly journals Clinical Efficacy of Traditional Chinese Medicine, Suan Zao Ren Tang, for Sleep Disturbance during Methadone Maintenance: A Randomized, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Yuan-Yu Chan ◽  
Yi-Hung Chen ◽  
Szu-Nian Yang ◽  
Wan-Yu Lo ◽  
Jaung-Geng Lin
Keyword(s):  
Sleep Quality ◽  
Sleep Disturbances ◽  
Methadone Maintenance ◽  
Controlled Trial ◽  
Intervention Group ◽  
Placebo Treatment ◽  
Sleep Efficiency ◽  
Opiate Dependence ◽  
Double Blind ◽  
Sleep Complaints

Methadone maintenance therapy is an effective treatment for opiate dependence, but more than three-quarters of persons receiving the treatment report sleep quality disturbances. In this double-blind, randomized, controlled trial, we recruited 90 individuals receiving methadone for at least one month who reported sleep disturbances and had Pittsburgh Sleep Quality Index (PSQI) scores > 5. The purpose of this study was to determine whether Suan Zao Ren Tang, one of the most commonly prescribed traditional Chinese medications for treatment of insomnia, improves subjective sleep among methadone-maintained persons with disturbed sleep quality. Ninety patients were randomly assigned to intervention group (n=45) and placebo group (n=45), and all participants were analyzed. Compared with placebo treatment, Suan Zao Ren Tang treatment for four weeks produced a statistically significant improvement in the mean total PSQI scores (P=0.007) and average sleep efficiency (P=0.017). All adverse events (e.g., lethargy, diarrhea, and dizziness) were mild in severity. Suan Zao Ren Tang is effective for improving sleep quality and sleep efficiency among methadone-maintained patients with sleep complaints.

scholarly journals Differential Effects of DHA- and EPA-Rich Oils on Sleep in Healthy Young Adults: A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 248
Author(s):  
Michael J. Patan ◽  
David O. Kennedy ◽  
Cathrine Husberg ◽  
Svein Olaf Hustvedt ◽  
Philip C. Calder ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Controlled Trial ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Omega 3 ◽  
Double Blind ◽  
Differential Effects ◽  
Positive Effects ◽  
Time In Bed ◽  
Oily Fish

Emerging evidence suggests that adequate intake of omega-3 polyunsaturated fatty acids (n-3 PUFAs), which include docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), might be associated with better sleep quality. N-3 PUFAs, which must be acquired from dietary sources, are typically consumed at suboptimal levels in Western diets. Therefore, the current placebo-controlled, double-blind, randomized trial, investigated the effects of an oil rich in either DHA or EPA on sleep quality in healthy adults who habitually consumed low amounts of oily fish. Eighty-four participants aged 25–49 years completed the 26-week intervention trial. Compared to placebo, improvements in actigraphy sleep efficiency (p = 0.030) and latency (p = 0.026) were observed following the DHA-rich oil. However, these participants also reported feeling less energetic compared to the placebo (p = 0.041), and less rested (p = 0.017), and there was a trend towards feeling less ready to perform (p = 0.075) than those given EPA-rich oil. A trend towards improved sleep efficiency was identified in the EPA-rich group compared to placebo (p = 0.087), along with a significant decrease in both total time in bed (p = 0.032) and total sleep time (p = 0.019) compared to the DHA-rich oil. No significant effects of either treatment were identified for urinary excretion of the major melatonin metabolite 6-sulfatoxymelatonin. This study was the first to demonstrate some positive effects of dietary supplementation with n-3 PUFAs in healthy adult normal sleepers, and provides novel evidence showing the differential effects of n-3 PUFA supplements rich in either DHA or EPA. Further investigation into the mechanisms underpinning these observations including the effects of n-3 PUFAs on sleep architecture are required.

scholarly journals A Randomized, Double-Blind, Placebo-Controlled Trial of a Polyphenol Botanical Blend on Sleep and Daytime Functioning

2021 ◽  
Vol 18 (6) ◽  
pp. 3044
Author(s):  
Andrew S. Tubbs ◽  
Kathryn E. R. Kennedy ◽  
Pamela Alfonso-Miller ◽  
Chloe C. A. Wills ◽  
Michael A. Grandner
Keyword(s):  
Side Effects ◽  
Sleep Quality ◽  
Sleep Disturbances ◽  
Controlled Trial ◽  
Epigallocatechin Gallate ◽  
Neurocognitive Functioning ◽  
Sleep Diary ◽  
Double Blind ◽  
Daytime Functioning ◽  
Insomnia Severity

Despite the high prevalence of subclinical sleep disturbances, existing treatments are either potent prescription medications or over-the-counter supplements with minimal scientific support and numerous side effects. However, preliminary evidence shows that polyphenols such as rosmarinic acid and epigallocatechin gallate can support healthy sleep without significant side effects. Therefore, the present study examined whether a polyphenol botanical blend (PBB) could improve sleep and/or daytime functioning in individuals with subclinical sleep disturbances. A total of 89 individuals completed a double-blind, randomized trial of daily treatment with PBB (n = 43) or placebo (n = 46) 30 min before bed for 30 days. Participants were monitored for changes in sleep (by sleep diary and an activity tracker), mood, and neurocognitive functioning. After 30 days, PBB improved diary sleep quality (p = 0.008) and reduced insomnia severity (p = 0.044) when compared to placebo. No other changes in sleep outcomes were observed. Additionally, PBB did not impair neurocognitive functioning, and some improvement was noted in vigilant attention, working memory, and risk assessment. Among individuals with subclinical sleep disturbances, PBB improved sleep quality, insomnia severity, and neurocognitive functioning over placebo. These findings indicate that polyphenol compounds may be useful for improving certain aspects of sleep without compromising neurocognitive functioning.

scholarly journals Effects of melatonin on sleep disturbances in multiple sclerosis: A randomized, controlled pilot study

2021 ◽  
Vol 7 (4) ◽  
pp. 205521732110487
Author(s):  
Wan-Yu Hsu ◽  
Annika Anderson ◽  
William Rowles ◽  
Katherine E. Peters ◽  
Vicki Li ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Sleep Quality ◽  
Sleep Disturbances ◽  
Total Sleep Time ◽  
Low Cost ◽  
Sleep Time ◽  
Sleep Efficiency ◽  
Double Blind ◽  
Randomized Controlled ◽  
Patient Reported

Background Sleep disturbances are commonly reported by people with multiple sclerosis (PwMS). However, optimal management of sleep disturbances is uncertain, and objective studies of sleep quality in PwMS are scarce. Objectives To determine the effect of exogenous melatonin on sleep quality and sleep disturbances in PwMS. Methods Thirty adult PwMS reporting sleep difficulties were recruited in a randomized, controlled, double-blind cross-over study. They took either melatonin or placebo for 2 weeks, and the opposite for the following 2 weeks. During weeks 2 and 4, an actigraph was used to capture mean total sleep time and sleep efficiency. Patient-reported outcomes (PROs) were collected at weeks 0, 2 and 4. Results Melatonin use significantly improved mean total sleep time ( p = 0.03), with a trend towards higher sleep efficiency ( p = 0.06). No PROs were significantly different; there was a trend for melatonin use to decrease mean Insomnia Severity Index score ( p = 0.07), improve Pittsburgh Sleep Quality Index sleep quality component ( p = 0.07), and improve NeuroQoL-Fatigue ( p = 0.06). No other PROs showed differences between melatonin and placebo; nor did step count measured by actigraphy (all p > 0.45). Conclusion These results provide preliminary evidence that melatonin, a low-cost, over-the-counter supplement, could improve objective measures of sleep quality in PwMS.

Relief of pain and trismus in patients treated with naproxen or acetylsalicylic acid after tonsillectomy

1988 ◽  
Vol 102 (1) ◽  
pp. 39-42 ◽  
Author(s):  
S. Kristensen ◽  
K. Tveteraas ◽  
P. Hein ◽  
H. B. Poulsen ◽  
K. E. Outzen
Keyword(s):  
Clinical Trial ◽  
Acetylsalicylic Acid ◽  
Pain Intensity ◽  
Sleep Disturbances ◽  
Significant Positive Correlation ◽  
Controlled Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Significant Difference ◽  
Therapeutic Gain

AbstractThe pain-relieving efficacy of naproxen and acetylsalicylic acid (ASA) in tonsillectomized patients was compared in a double blind parallel clinical trial comprising 83 patients, among whom 42 were treated with naproxen and 41 with ASA. The patients were treated post-operatively for two days with either naproxen suppositories 500 mg. twice, or ASA effervescent tablets 1000 mg. three times, daily.The therapeutic gain was evaluated by recording the intensity of pain, reduced ability to open the mouth (trismus), consumption of supplementary analgesic (parcetamol), and pain-related sleep disturbances.The statistical analysis of the results revealed no differences in pain intensity, consumption of additional analgesics or pain-related sleep disturbances in the two treatment groups. A considerable degree of trismus was demonstrated in most of the tonsillectomized patients. This reduced ability to open the mouth was gradually overcome in the naproxen group while it remained unchanged in the ASA group, however, no statistical significant difference could be demonstrated. Additionally, no significant positive correlation between pain intensity and trismus was proven. The pain-relieving effect, however, was unsatisfactory in both the naproxen and the ASA group, and clinical controlled trial studies of alternative analgetics in tonsillectomized patients are still to be encouraged.

601 Comparison of Sleep Parameters in Children with Achondroplasia and Trisomy 21

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A236-A237
Author(s):  
Jodi Gustave ◽  
Kaelyn Gaza ◽  
Jennifer Marriner ◽  
Seema Rani ◽  
Abigail Strang ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Rem Sleep ◽  
Trisomy 21 ◽  
Sleep Disturbances ◽  
Sleep Latency ◽  
Sleep Efficiency ◽  
Sleep Architecture ◽  
Poor Sleep ◽  
Arousal Index ◽  
Sleep Parameters

Abstract Introduction Children with achondroplasia and Trisomy 21 (T21) have increased incidence of sleep disturbances including sleep disordered breathing. Abnormal sleep architecture has been documented in children with T21. It is important to continue to analyze sleep parameters in both groups since poor sleep quality is associated with neurocognitive impairment. Methods Following IRB approval, we performed a retrospective chart review of patients at Nemours/A.I. duPont Hospital for Children in Wilmington, DE with achondroplasia and T21 who underwent an initial polysomnogram (PSG) between 2015 and 2020. We compared sleep architecture parameters between the groups including sleep efficiency, total sleep time (TST), sleep latency, arousal index and concentration of N3 and REM sleep. Results In patients with achondroplasia (n=49, mean age 5.8 months and 63.3% male), 12% reported restless sleep. PSG data revealed TST of 392 minutes, mean sleep efficiency of 82%, mean sleep latency of 9.4 min, mean arousal index of 40, 22% REM sleep and 32% N3 sleep. In the patients with T21 (n=32, mean age 17.8 months and 50% male), 59% reported restless sleep. PSG data revealed TST of 393 minutes, mean sleep efficiency of 82%, mean sleep latency of 14 minutes, arousal index of 35, 15% REM sleep and 40% N3 sleep. The differences in REM and N3 sleep between the two groups were statistically significant (p-values of 0.001 and 0.04, respectively), but the differences in arousal index, TST and sleep efficiency were not. Conclusion Our study showed that children with T21 subjectively noted more restless sleep compared to patients with achondroplasia although TST and sleep efficiency were similar. Patients with achondroplasia had a higher arousal index that was not statistically significant. Children with achondroplasia had a shorter sleep latency and more robust REM concentration, likely due to their younger age. There was a higher concentration of N3 sleep in patients with T21. This is likely due to the decrease in REM concentration. In conclusion, it is important to establish expected sleep parameters in patients with achondroplasia and T21 to maximize sleep quality and mitigate negative neurocognitive effects of poor sleep. Support (if any):

scholarly journals Effect of Melatonin on Cognitive Function and Sleep in relation to Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Melissa Voigt Hansen ◽  
Michael Tvilling Madsen ◽  
Lærke Toftegård Andersen ◽  
Ida Hageman ◽  
Lars Simon Rasmussen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Placebo Group ◽  
Cognitive Function ◽  
Cognitive Dysfunction ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Sleep Efficiency ◽  
Mean Difference ◽  
Double Blind ◽  
Double Blind Placebo

Background.Sleep disturbances and cognitive dysfunction are common in patients with breast cancer. Disturbed sleep leads to poor cognitive performance and exogenous melatonin may improve sleep and attenuate cognitive dysfunction. We hypothesized that melatonin would improve sleep and cognitive function after surgery.Methods.This study reports secondary endpoints from a randomized, double-blind, placebo-controlled trial. Women, 30–75 years, were randomized to 6mg oral melatonin/placebo for 3 months. We assessed postoperative cognitive dysfunction (POCD) with a neuropsychological test battery, sleep with a diary, and sleep quality with VAS.Results. 54 patients were randomized to melatonin (n=28) or placebo (n=26); 11 withdrew (10 placebo, 1 melatonin,P=0.002). The incidence of POCD was 0% (0/20) [95% CI 0.0%; 16.8%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 2 weeks postoperatively (P=1.00) and 6.3% (1/16) [95% CI 0.0%; 30.2%] in the placebo group and 0% (0/26) [95% CI 0.0%; 13.2%] in the melatonin group 12 weeks postoperatively (P=0.38). Sleep efficiency was significantly greater in the melatonin group; mean difference was 4.28% [95% CI 0.57; 7.82] (P=0.02). The total sleep period was significantly longer in the melatonin group; mean difference was 37.0 min [95% CI 3.6; 69.7] (P=0.03).Conclusion.Melatonin increased sleep efficiency and total sleep time but did not affect cognitive function. The dropout rate was significantly lower in the melatonin group. This trial is registered with Clinicaltrials.govNCT01355523.

scholarly journals Are you Sleeping? Pilot Comparison of Self-Reported and Objective Measures of Sleep Quality and Duration in an Inpatient Alcoholism Treatment Program

2012 ◽  
Vol 6 ◽  
pp. SART.S10385 ◽  
Author(s):  
Alyssa T. Brooks ◽  
Michael C. Krumlauf ◽  
Barbara P. Whiting ◽  
Rosa J. Clark ◽  
Gwenyth R. Wallen
Keyword(s):  
Sleep Quality ◽  
Sleep Duration ◽  
Sleep Disturbances ◽  
Sleep Efficiency ◽  
Objective Measures ◽  
Cutoff Score ◽  
Increase Risk ◽  
Inpatient Population ◽  
Ongoing Assessment ◽  
Alcohol Dependent

Sleep disturbances are common among alcohol-dependent individuals and can increase risk of relapse. The current study compares subjective and objective measures of sleep quality and duration and describes the prevalence of baseline sleep disturbances in an inpatient population of alcoholics undergoing their first week of detoxification. At baseline, the PSQI revealed that 79% of participants were above the cutoff score (≥5) for clinically meaningful sleep disturbances (mean = 12.57, SD = 4.38). Actigraphy results revealed that average sleep efficiency was 75.89%. Sleep efficiency scores were significantly correlated with self-reported sleep efficiency ( P = 0.04, r = 0.47). Sleep duration measured by the actigraphy watches was not significantly correlated with self-reported sleep duration ( P = 0.65, r = 0.10). Ongoing assessment of sleep disturbances may be a valuable tool for informing the development of customized sleep interventions in a similar inpatient alcohol treatment sample.

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