scholarly journals Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Amanda Rao ◽  
Phillippa Ebelt ◽  
Alistair Mallard ◽  
David Briskey
Keyword(s):  
Sleep Quality ◽  
Sleep Disturbance ◽  
Acid Amide ◽  
Sleep Onset ◽  
Trial Registration ◽  
Sleep Onset Latency ◽  
Double Blind ◽  
Endogenous Fatty Acid ◽  
Wrist Actigraphy ◽  
Wide Range

Abstract Background Sleep is essential for wellbeing, yet sleep disturbance is a common problem linked to a wide range of health conditions. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide proposed to promote better sleep via potential interaction with the endocannabinoid system. Methods This double-blind, randomised study on 103 adults compared the efficacy and tolerability of 8 weeks of daily supplemented PEA formulation (350 mg Levagen + ®) to a placebo. Sleep quality and quantity were measured using wrist actigraphy, a sleep diary and questionnaires. Results At week 8, PEA supplementation reduced sleep onset latency, time to feel completely awake and improved cognition on waking. After 8 weeks, both groups improved their sleep quality and quantity scores similarly. There was no difference between groups at baseline or week 8 for sleep quantity or quality as measured from actigraphy or sleep diaries. Conclusion These findings support PEA as a potential sleeping aid capable of reducing sleep onset time and improving cognition on waking. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12618001339246. Registered 9th August 2018.

scholarly journals Palmitoylethanolamide for Sleep Disturbance. A Double-blind, Randomised, Placebo-controlled Interventional Study

2021 ◽  
Author(s):  
Amanda Rao ◽  
Phillippa Ebelt ◽  
Alistair Mallard ◽  
David Briskey
Keyword(s):  
Sleep Quality ◽  
Sleep Disturbance ◽  
Acid Amide ◽  
Sleep Onset ◽  
Trial Registration ◽  
Sleep Onset Latency ◽  
Double Blind ◽  
Endogenous Fatty Acid ◽  
Wrist Actigraphy ◽  
Wide Range

Abstract Background: Sleep is essential for wellbeing, yet sleep disturbance is a common problem linked to a wide range of health conditions. Palmitoylethanolamide (PEA) is an endogenous fatty acid amide proposed to promote better sleep via potential interaction with the endocannabinoid system.Methods: This double-blind, randomized study on 103 adults compared the efficacy and tolerability of 8 weeks of daily supplemented PEA formulation (350 mg Levagen+TM) to a placebo. Sleep quality and quantity were measured using wrist actigraphy, a sleep diary and questionnaires. Results: At week 8, PEA supplementation reduced sleep onset latency, time to feel completely awake and improved cognition on waking. After 8 weeks, both groups improved their sleep quality and quantity scores similarly. There was no difference between groups at baseline or week 8 for sleep quantity or quality as measured from actigraphy or sleep diaries. Conclusion: These findings support PEA as a potential sleeping aid capable of reducing sleep onset time and improving cognition on waking. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12618001339246. Registered 9th August 2018, http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375493&isReview=true

scholarly journals 0468 A Multiple Dose, Placebo-Controlled, Randomized Double-Blind, Multicenter Study to Investigate Triprolidine in the Treatment of Temporary Sleep Disturbance

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A179-A180
Author(s):  
L Reyner ◽  
J E Miller ◽  
T Shea
Keyword(s):  
Sleep Disturbance ◽  
Daytime Sleepiness ◽  
Multiple Dose ◽  
Dose Range ◽  
Randomized Study ◽  
Sleep Onset ◽  
Primary Diagnosis ◽  
Optimum Dose ◽  
Sleep Onset Latency ◽  
Double Blind

Abstract Introduction American Association of Sleep Medicine guidelines states that the primary goals of the treatment of insomnia are to improve sleep quality and related daytime function. While H1 antihistamines have sedative effects, they are associated with residual daytime sleepiness and an effective dose range for hypnotic effect has hitherto not been established. Triprolidine a first generation antihistamine used to treat allergic rhinitis and the common cold has a mean half-life of 3.2 hours. We evaluated the effect of two doses of triprolodine compared with placebo on sleep onset latency and daytime sleepiness to determine the optimum dose in subjects with temporary sleep disturbance. Methods Multicenter, placebo-controlled, parallel group, double blind, multiple dose, randomized study of 178 patients aged 18 years or above with a primary diagnosis of temporary sleep disturbance. Patients were randomized to one of three groups. Group 1: 2 x placebo tablets; Group 2: 1 x placebo tablet + 1 x 2.5mg triprolidine tablet; Group 3: 2 x 2.5mg triprolodine tablets, taken 20 minutes before intended sleep on three consecutive evenings. Efficacy was measured objectively using the Sleep Disturbance Index using a wrist actimeter and subjectively using the Loughborough Sleep Log and Karolinska Sleepiness Scale. Results Both doses were statistically significantly superior to placebo in terms of quality and duration of sleep and sleep interruptions. No hangover effects or daytime sleepiness were observed with either dose compared to placebo. Patients on the 2.5 mg dose awoke more refreshed than the 5 mg dose. No serious adverse effects observed in any group and anticholinergic events i.e. dry mouth were very low. Conclusion Tripolidine is effective and safe in the treatment of temporary sleep disturbance. The optimum dose is 2.5mg. Support The study was sponsored by Boots Healthcare International.

scholarly journals Assessing sleep quality in older adults: A comparison of three measurement approaches

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 882-882
Author(s):  
Amy Berkley ◽  
Patricia Carter
Keyword(s):  
Older Adults ◽  
Sleep Quality ◽  
Assessment Tool ◽  
Sleep Problems ◽  
Adult Population ◽  
Sleep Onset ◽  
Self Report ◽  
Sleep Onset Latency ◽  
Wrist Actigraphy ◽  
Sleep Assessment

Abstract Discrepancies between subjective and objective sleep measures have been reported for some time; however, it is critical to consider the implications of inaccurate or incomplete sleep assessment for frail older adults who are struggling to maintain independence. To compare sleep assessment methods, we collected objective sleep measurements (via wrist actigraphy), subjective measures via self-report sleep surveys (Pittsburgh Sleep Quality Index; Insomnia Severity Index, Sleep Hygiene Index), and qualitative data through semi-structured audio-recorded interviews, from 8 older adults who self-reported sleep problems while living in a retirement community in southwestern US. Participants’ objective sleep (Total Sleep Time, Sleep Onset Latency, Wake After Sleep Onset, and Sleep Efficiency) and qualitative narratives were congruent, but self-report measures failed to capture several unique sleep problems identified in the sample. Disordered sleep in older adults has been linked to increased incidence of falls, depression and anxiety, cognitive impairment, institutionalization, and mortality, but traditional sleep assessment instruments, designed for the general adult population, fail to capture many of the experiences and causes that are unique to older adults. functioning. A sleep assessment tool designed to measure older people’s sleep experiences could provide more accurate and sensitive data.

Sleep disturbance in mild cognitive impairment: differential effects of current and remitted depression

2011 ◽  
Vol 23 (4) ◽  
pp. 167-172 ◽  
Author(s):  
Sharon L. Naismith ◽  
Naomi L. Rogers ◽  
Simon J. G. Lewis ◽  
Keri Diamond ◽  
Zoë Terpening ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Major Depression ◽  
Sleep Quality ◽  
Sleep Disturbance ◽  
Rating Scale ◽  
Sleep Onset ◽  
Sleep Onset Latency ◽  
Differential Effects ◽  
Remitted Depression

Naismith SL, Rogers NL, Lewis SJG, Diamond K, Terpening Z, Norrie L, Hickie IB. Sleep disturbance in mild cognitive impairment: differential effects of current and remitted depression.Objective:Although patients with mild cognitive impairment (MCI) commonly report sleep disturbance, the extent to which depressive symptoms contribute to this relationship is unclear. This study sought to delineate the contribution of current and remitted major depression (MD) to sleep disturbance in MCI.Methods:Seventy-seven patients meeting criteria for MCI (mean age = 66.6 ± 8.8 years) were grouped according to those withnohistory of depression (MCI,n= 33), those meeting criteria forcurrentMD [mild cognitive impairment and meeting criteria for current major depression (DEP-C),n= 14] and those withremittedMD [mild cognitive impairment and remitted major depression (DEP-R),n= 30]. Additionally, 17 healthy controls (CON) participated. Sleep was patient-rated using the Pittsburgh Sleep Quality Index and included assessment of sleep quality, duration, efficiency, disturbances, medications, sleep onset latency and daytime dysfunction. Depression severity was clinician-rated using the Hamilton Depression Rating Scale.Results:Overall sleep disturbance was significantly greater in the DEP-C and DEP-R groups in comparison to the CON and MCI groups (p< 0.001). Only 12% of CON reported sleep disturbance, compared to 30% of MCI, 63% of DEP-R and 86% of DEP-C. Sub-scale analysis showed that the sleep disturbance in depressive groups was most evident across the domains of sleep quality, sleep efficiency, sleep latency and daytime dysfunction.Conclusion:Sleep disturbance in MCI is strongly associated with a current or past diagnosis of MD. The finding that sleep complaints are still prominent in those with remitted depression, suggests that ‘trait' markers exist that may reflect underlying neurobiological changes within the sleep–wake system.

scholarly journals A Double-Blind, Randomized, Placebo-Controlled Crossover Clinical Study of the Effects of Alpha-s1 Casein Hydrolysate on Sleep Disturbance

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1466
Author(s):  
Hyeon Jin Kim ◽  
Jiyeon Kim ◽  
Seungyeon Lee ◽  
Bosil Kim ◽  
Eunjin Kwon ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Sleep Disturbance ◽  
Sleep Onset ◽  
Casein Hydrolysate ◽  
Group Differences ◽  
Poor Sleep ◽  
Moderate Degree ◽  
Double Blind ◽  
Significant Group ◽  
Similar Tendency

This study evaluated the effects of alpha-s1 casein hydrolysate (ACH; Lactium®) on the subjective and objective sleep profiles of a community-based sample of Koreans with poor sleep quality. We performed a double-blind, randomized crossover trial with 48 participants (49.0 ± 1.7 years old, 65% female) who exhibited a mild to moderate degree of sleep disturbance. Either ACH or placebo was administered for the initial four weeks, and the counterpart was administered in precisely the same manner after a four-week washout period. Sleep disturbance scales, daytime functioning, and psychiatric aspects showed a similar tendency to improve during both ACH and placebo phases without significant group differences. Overall perceived sleep profiles in sleep diaries were significantly improved during the ACH phase, represented by increased total sleep time and sleep efficiency (SE), as well as decreased sleep latency and wake after sleep onset (WASO). Interestingly, actigraphy demonstrated significantly increased SE after continuous use of ACH for four weeks, clearly more improved when compared to two weeks of use. The polysomnography measures showed a similar tendency without statistically significant group differences. Our findings suggest that refined ACH was well tolerated and could improve sleep quality, with possible cumulative beneficial effects with long-term administration.

scholarly journals Assessing sleep-wake survival dynamics in relation to sleep quality in a placebo-controlled pharmacological intervention study with people with insomnia and healthy controls

2020 ◽  
Vol 238 (1) ◽  
pp. 83-94
Author(s):  
Lieke W. A. Hermans ◽  
Marta Regis ◽  
Pedro Fonseca ◽  
Sebastiaan Overeem ◽  
Tim R. M. Leufkens ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Sleep Onset ◽  
Sleep Fragmentation ◽  
Pharmacological Intervention ◽  
Segment Length ◽  
Prediction Errors ◽  
Sleep Onset Latency ◽  
Healthy Controls ◽  
Subjective Sleep Quality ◽  
Double Blind

Abstract Rationale The mechanisms underlying impaired sleep quality in insomnia are not fully known, but an important role for sleep fragmentation has been proposed. Objectives The aim of this study is to explore potential mechanisms of sleep fragmentation influencing alterations of perceived sleep quality. Methods We analyzed polysomnography (PSG) recordings from a double-blind crossover study with zopiclone 7.5 mg and placebo, in elderly participants with insomnia complaints and age-matched healthy controls. We compared survival dynamics of sleep and wake across group and treatment. Subsequently, we used a previously proposed model to estimate the amount of sleep onset latency (SOL) misperception from PSG-defined sleep fragmentation. Self-reported and model-estimated amount of SOL misperception were compared across group and treatment, as well as model prediction errors. Results In the zopiclone night, the average segment length of NREM sleep was increased (group F = 1.16, p = 0.32; treatment F = 8.89, p< 0.01; group x treatment F = 0.44, p = 0.65), while the segment length of wake was decreased (group F = 1.48, p = 0.23; treatment F = 11.49, p< 0.01; group x treatment F = 0.36, p = 0.70). The self-reported and model-estimated amount of SOL misperception were lower during the zopiclone night (self-reported group F = 6.08, p< 0.01, treatment F = 10.8, p< 0.01, group x treatment F = 2.49, p = 0.09; model-estimated F = 1.70, p = 0.19, treatment F = 16.1, p< 0.001, group x treatment F = 0.60, p = 0.55). The prediction error was not altered (group F = 1.62, p = 0.20; treatment F = 0.20, p = 0.65; group x treatment F = 1.01, p = 0.37). Conclusions Impaired subjective sleep quality is associated with decreased NREM stability, together with increased stability of wake. Furthermore, we conclude that zopiclone-induced changes in SOL misperception can be largely attributed to predictable changes of sleep architecture.

Sleep and Salivary Testosterone and Cortisol During a Short Preseason Camp: A Study in Professional Rugby Union

2019 ◽  
Vol 14 (6) ◽  
pp. 796-804 ◽  
Author(s):  
Benjamin G. Serpell ◽  
Barry G. Horgan ◽  
Carmen M.E. Colomer ◽  
Byron Field ◽  
Shona L. Halson ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Muscle Soreness ◽  
Sleep Onset ◽  
Sleep Efficiency ◽  
Sleep Onset Latency ◽  
Hormone Concentration ◽  
Salivary Testosterone ◽  
Training Camp ◽  
Wrist Actigraphy ◽  
Rugby Players

Purpose: To examine changes in, and relationships between, sleep quality and quantity, salivary testosterone, salivary cortisol, testosterone-to-cortisol ratio (T:C), and self-reported muscle soreness during a residential-based training camp in elite rugby players. Methods: Nineteen male rugby players age 26.4 (3.9) years, height 186.0 (9.4) cm, and weight 104.1 (13.4) kg (mean [SD]) participated in this study. Wrist actigraphy devices were worn for 8 nights around a 4-d training camp (2 nights prior, during, and 2 nights after). Sleep-onset latency, sleep duration, sleep efficiency, and waking time were measured. Participants provided saliva samples during camp on waking and again 45 min later, which were then assayed for testosterone and cortisol levels. They also rated their general muscle soreness daily. Results: Little variation was observed for sleep quality and quantity or testosterone. However, significant differences were observed between and within days for cortisol, T:C, and muscle soreness (P < .001). Few relationships were observed for sleep and hormones; the strongest, an inverse relationship for sleep efficiency and T:C (r = −.372, P < .01). Conclusions: There may be no clear and useful relationship between sleep and hormone concentration in a short-term training camp context, and measures of sleep and testosterone and cortisol should be interpreted with caution because of individual variation. Alterations in hormone concentration, particularly cortisol, may be affected by other factors including anticipation of the day ahead. This study adds to our knowledge that changes in hormone concentration are individual and context specific.

scholarly journals 0264 Childhood Adversity And Adult Sleep: The Role Of Deprivation And Threat

SLEEP ◽  
2019 ◽  
Vol 42 (Supplement_1) ◽  
pp. A108-A108
Author(s):  
Matthew R Cribbet ◽  
Paula G Williams ◽  
Ruben Tinajero ◽  
Holly K Rau
Keyword(s):  
Alcohol Use ◽  
Sleep Quality ◽  
Sleep Onset ◽  
Childhood Adversity ◽  
Equation Modeling ◽  
Sleep Onset Latency ◽  
Adult Health ◽  
Wrist Actigraphy ◽  
Physical Neglect ◽  
Restorative Sleep

Abstract Introduction There are robust associations between childhood adversity (CA) and poor physical health in adulthood. Sleep is a possible mechanism linking CA to adult health. The prevailing approach for testing associations between CA and adult sleep offers little insight into which aspects of CA are related to specific sleep outcomes. To better understand associations between CA and adult sleep outcomes, we tested a conceptual model that distinguishes between threat (e.g. physical, emotional and sexual abuse), and deprivation (e.g. emotional and physical neglect). Methods Participants (N= 79; Mage = 27.48(SD=6.53); 68% Female) were screened for insomnia disorder, mental health conditions and physical illnesses. Participants completed demographic and depressive symptom measures, along with the Childhood Trauma Questionnaire, a self-report retrospective measure that captures dimensions of threat and deprivation. Sleep duration, latency, efficiency, wake after sleep onset (WASO), and secondary sleep onset latency (SSOL) were averaged across 3 consecutive days of wrist actigraphy and sleep diaries. Daily ratings of sleep-quality, non-restorative sleep, alcohol use and current stress were averaged across 3 days. Structural equation modeling (SEM) was used to account for missing data. All SEM models included correlated measures of deprivation and threat along with age, sex, BMI, alcohol use, daily stress, and depressive symptoms. Results In SEM models, threat was significantly positively associated with non-restorative sleep (b = .046, p &lt;.001) and sleep quality (b=.025, p=.008), but unrelated to all other diary-based and actigraphy-based sleep measures (ps &gt; .05). Deprivation was significantly negatively associated with diary-based WASO (b = -.076, p = .003) and SSOL, but unrelated to all other diary-based and actigraphy-based sleep measures (ps &gt; .05). Conclusion These results begin to clarify associations between related, but distinct forms of CA and specific adult sleep outcomes. Identifying specific pathways linking CA and adult health is critical for developing interventions and mitigating future health risk. Support (If Any) This study was funded by a Funding Incentive Seed Grant from the University of Utah, the Mind and Life Institute, and Division 38 of the American Psychological Association.

scholarly journals FAAH and CNR1 Polymorphisms in the Endocannabinoid System and Alcohol-Related Sleep Quality

2021 ◽  
Vol 12 ◽  
Author(s):  
Soundarya Soundararajan ◽  
Narjis Kazmi ◽  
Alyssa T. Brooks ◽  
Michael Krumlauf ◽  
Melanie L. Schwandt ◽  
...  
Keyword(s):  
Alcohol Consumption ◽  
Sleep Quality ◽  
Sleep Disturbance ◽  
Sleep Disturbances ◽  
Acid Amide ◽  
Sleep Onset ◽  
Endocannabinoid System ◽  
Sleep Efficiency ◽  
Subjective Sleep Quality

Sleep disturbances are common among individuals with alcohol use disorder (AUD) and may not resolve completely with short-term abstinence from alcohol, potentially contributing to relapse to drinking. The endocannabinoid system (ECS) is associated with both sleep and alcohol consumption, and genetic variation in the ECS may underlie sleep-related phenotypes among individuals with AUD. In this study, we explored the influence of genetic variants in the ECS (Cannabinoid receptor 1/CNR1: rs806368, rs1049353, rs6454674, rs2180619, and Fatty Acid Amide Hydrolase/FAAH rs324420) on sleep quality in individuals with AUD (N = 497) and controls without AUD (N = 389). We assessed subjective sleep quality (from the Pittsburgh Sleep Quality Index/PSQI) for both groups at baseline and objective sleep efficiency and duration (using actigraphy) in a subset of individuals with AUD at baseline and after 4 weeks of inpatient treatment. We observed a dose-dependent relationship between alcohol consumption and sleep quality in both AUD and control groups. Sleep disturbance, a subscale measure in PSQI, differed significantly among CNR1 rs6454674 genotypes in both AUD (p = 0.015) and controls (p = 0.016). Only among controls, neuroticism personality scores mediated the relationship between genotype and sleep disturbance. Objective sleep measures (sleep efficiency, wake bouts and wake after sleep onset), differed significantly by CNR1 rs806368 genotype, both at baseline (p = 0.023, 0.029, 0.015, respectively) and at follow-up (p = 0.004, p = 0.006, p = 0.007, respectively), and by FAAH genotype for actigraphy recorded sleep duration at follow-up (p = 0.018). These relationships suggest a significant role of the ECS in alcohol-related sleep phenotypes.

The effect of 4-h versus 6-h time restricted feeding on sleep quality, duration, insomnia severity and obstructive sleep apnea in adults with obesity

2021 ◽  
pp. 026010602110023
Author(s):  
Sofia Cienfuegos ◽  
Kelsey Gabel ◽  
Faiza Kalam ◽  
Mark Ezpeleta ◽  
Vicky Pavlou ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Sleep Quality ◽  
Sleep Onset ◽  
Control Group ◽  
Sleep Onset Latency ◽  
Restricted Feeding ◽  
Wake Time ◽  
Obstructive Sleep ◽  
Insomnia Severity

Background: Time restricted feeding (TRF) involves deliberately restricting the times during which energy is ingested. Preliminary findings suggest that 8–10-h TRF improves sleep. However, the effects of shorter TRF windows (4–6 h) on sleep, remain unknown. Aims: This study compared the effects of 4-h versus 6-h TRF on sleep quality, duration, insomnia severity and the risk of obstructive sleep apnea. Methods: Adults with obesity ( n = 49) were randomized into one of three groups: 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions) for 8 weeks. Results: After 8 weeks, body weight decreased ( p < 0.001) similarly by 4-h TRF (–3.9 ± 0.4 kg) and 6-h TRF (–3.4 ± 0.4 kg), versus controls. Sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI), did not change by 4-h TRF (baseline: 5.9 ± 0.7; week 8: 4.8 ± 0.6) or 6-h TRF (baseline: 6.4 ± 0.8; week 8: 5.3 ± 0.9), versus controls. Wake time, bedtime, sleep duration and sleep onset latency also remained unchanged. Insomnia severity did not change by 4-h TRF (baseline: 4.4 ± 1.0; week 8: 4.7 ± 0.9) or 6-h TRF (baseline: 8.3 ± 1.2; week 8: 5.5 ± 1.1), versus controls. Percent of participants reporting obstructive sleep apnea symptoms did not change by 4-h TRF (baseline: 44%; week 8: 25%) or 6-h TRF (baseline: 47%; week 8: 20%), versus controls. Conclusion: These findings suggest that 4- and 6-h TRF have no effect on sleep quality, duration, insomnia severity, or the risk of obstructive sleep apnea.

Sign in / Sign up

Export Citation Format

Share Document