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 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 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 Moderate Exercise Plus Sleep Education Improves Self-Reported Sleep Quality, Daytime Mood, and Vitality in Adults with Chronic Sleep Complaints: A Waiting List-Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-10 ◽  
Author(s):  
Carmen Gebhart ◽  
Daniel Erlacher ◽  
Michael Schredl
Keyword(s):  
Physical Exercise ◽  
Sleep Quality ◽  
Controlled Trial ◽  
Sleep Onset ◽  
Intervention Group ◽  
Waiting List ◽  
Control Group ◽  
Sleep Education ◽  
Sleep Complaints ◽  
Chronic Sleep

Research indicates that physical exercise can contribute to better sleep quality. This study investigates the six-week influence of a combined intervention on self-rated sleep quality, daytime mood, and quality of life. A nonclinical sample of 114 adults with chronic initiating and the maintaining of sleep complaints participated in the study. The intervention group of 70 adults underwent moderate physical exercise, conducted weekly, plus sleep education sessions. Improvements among participants assigned to the intervention group relative to the waiting-list control group (n=44) were noted for subjective sleep quality, daytime mood, depressive symptoms and vitality. Derived from PSQI subscores, the intervention group reported increased sleep duration, shortened sleep latency, fewer awakenings after sleep onset, and overall better sleep efficiency compared to controls. The attained scores were well sustained and enhanced over a time that lasted through to the follow-up 18 weeks later. These findings have implications in treatment programs concerning healthy lifestyle approaches for adults with chronic sleep complaints.

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 Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-10
Author(s):  
Udo Bongartz ◽  
Bee-Kwan Tan ◽  
Stephanie Seibt ◽  
Gordana Bothe ◽  
Ralf Uebelhack ◽  
...  
Keyword(s):  
Sleep Disturbances ◽  
Controlled Trial ◽  
Composite Score ◽  
Sleep Diary ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Sleep Complaints ◽  
Activity Tracker ◽  
Athens Insomnia Scale ◽  
Sleep Parameters

Objective. The purpose of this study was to explore the clinical benefit and tolerability of IQP-AO-101 in healthy subjects with sleep complaints. Methods. This double-blind, randomized, placebo-controlled trial involved fifty subjects with sleep complaints. Subjects with a Pittsburgh Sleep Quality Index (PSQI) score between 6 and 15 were randomized to receive either IQP-AO-101 or placebo for 6 weeks, following a run-in period of one week. Sleep parameters were assessed at baseline and after 1, 4, and 6 weeks using the modified Athens Insomnia Scale (mAIS). Subjects were also instructed to wear an activity tracker and keep a sleep diary during the study. Other questionnaires administered were the Frankfurt Attention Inventory (FAIR-2) and the Profile of Mood States (POMS-65). Blood samples for safety laboratory parameters were taken before and at the end of the study. Results. After 6 weeks, subjects who consumed IQP-AO-101 reported significant improvements in mAIS scores compared with placebo, including mAIS total score (11.76 ± 6.85 vs 4.00 ± 4.80; p < 0.001); night parameters composite score (5.20 ± 3.80 vs 2.04 ± 3.16; p = 0.001); and day parameters composite score (6.56 ± 4.10 vs 1.96 ± 2.65; p < 0.001). All individual parameters (Items 1 to 8) were also significantly improved from baseline after 6 weeks of IQP-AO-101 intake. Analysis of variance with baseline values as covariates showed statistically significant improvements across all individual parameters for IQP-AO-101 when compared to placebo. The measurements using the activity tracker, sleep diary, FAIR-2, and POMS did not reveal any significant differences between groups. No adverse effects related to the intake of IQP-AO-101 were reported. Tolerability was rated as very good by all the subjects and by the investigator for all cases. Conclusions. In this study, IQP-AO-101 was well tolerated and efficacious for promoting sleep and enhancing daytime performance in subjects with moderate sleep disturbances. Clinical Trial Registration. This trial is registered with ClinicalTrials.gov, no. NCT03114696.

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.

scholarly journals Identifying and Treating Opioid Side Effects

2019 ◽  
Vol 130 (1) ◽  
pp. 142-148 ◽  
Author(s):  
Jonathan Moss
Keyword(s):  
Placebo Group ◽  
Transit Time ◽  
Methadone Maintenance ◽  
Controlled Trial ◽  
Intervention Group ◽  
Treated Group ◽  
Opioid Withdrawal ◽  
University Hospital ◽  
Double Blind ◽  
Opioid Administration

Abstract Methylnaltrexone Reverses Chronic Opioid-induced Constipation: A Randomized, Controlled Trial. By Yuan CS, Foss JF, O’Connor M, Osinski J, Karrison T, Moss J, Roizen MF. JAMA 2000; 130:142–8. Reprinted with permission. Context Constipation is the most common chronic adverse effect of opioid pain medications in patients who require long-term opioid administration, such as patients with advanced cancer, but conventional measures for ameliorating constipation often are insufficient. Objective To evaluate the efficacy of methylnaltrexone, the first peripheral opioid receptor antagonist, in treating chronic methadone-induced constipation. Design Double-blind, randomized, placebo-controlled trial conducted between May 1997 and December 1998. Setting Clinical research center of a university hospital. Participants Twenty-two subjects (9 men and 13 women; mean [SD] age, 43.2 [5.5] years) enrolled in a methadone maintenance program and having methadone-induced constipation. Main Outcome Measures Laxation response, oral-cecal transit time, and central opioid withdrawal symptoms were compared between the 2 groups. Results The 11 subjects in the placebo group showed no laxation response, and all 11 subjects in the intervention group had laxation response after intravenous methylnaltrexone administration (P&lt;.001). The oral-cecal transit times at baseline for subjects in the methylnaltrexone and placebo groups averaged 132.3 and 126.8 minutes, respectively. The average (SD) change in the methylnaltrexone-treated group was −77.7 (37.2) minutes, significantly greater than the average change in the placebo group (−1.4 [12.0] minutes; P&lt;.001). No opioid withdrawal was observed in any subject, and no significant adverse effects were reported by the subjects during the study. Conclusions Our data demonstrate that intravenous methylnaltrexone can induce laxation and reverse slowing of oral cecal-transit time in subjects taking high opioid dosages. Low-dosage methylnaltrexone may have clinical utility in managing opioid-induced constipation.

scholarly journals EFFECTS OF ALPHA-S1-CASEIN TRYPTIC HYDROLYSATE AND L-THEANINE ON SLEEP DISORDER AND PSYCHOLOGICAL COMPONENTS: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

2019 ◽  
Vol 19 (1) ◽  
pp. 47-55
Author(s):  
Chee Huei Phing ◽  
Ong Yong Chee
Keyword(s):  
Placebo Group ◽  
Sleep Quality ◽  
Sleep Disorder ◽  
Sleep Disturbances ◽  
Intervention Group ◽  
Milk Powder ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Tryptic Hydrolysate

Sleep disorder is common among the general population. A nutritional supplement containing alpha-s1-casein tryptic hydrolysate and L-theanine was evaluated for its effects in improving sleep quality. The study was conducted using a double-blind randomized trial.  Intervention group received once-daily capsules of 150 mg alpha s1 casein tryptic hydrolysate and 50 mg L-theanine, and the control group were given placebo (150 mg skimmed milk powder) for four weeks. The outcome measurements were assessed on weekly basis using PSQI, DASS-21, clinical and biochemical parameters. ANOVA test were used to assess within group differences and ANCOVA were used to check for differences between groups. Significantly lower (better) sleep latency score, sleep disturbances score and daytime dysfunction score were demonstrated on week-4 in intervention group compared to placebo group. Profound differences were observed between the two groups for anxiety and stress scores from week-3 onwards, in which lower anxiety and stress scores were observed in intervention group compared to placebo group. In addition, significantly lower depression score in intervention group compared to placebo group on week-4 was observed. Intervention supplement has demonstrated potent effects in relieving anxiety, stress, depression and sleep quality.

scholarly journals Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension

2021 ◽  
Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Crossover Study ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Sleep Complaints ◽  
Open Label Extension

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.

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