Efficacy and safety of electroacupuncture treatment in the prevention of negative moods in healthy young men after 30 h of total sleep deprivation: study protocol for a single-center, single-blind, parallel-arm, randomized clinical trial.

BACKGROUND: Sleep deprivation (SD) among young adults is a major public health concern. In humans, it has adverse effects on mood and results in serious health problems. Faced with SD, persons may take precautionary measures to try and reduce their risk. The aim of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for the prevention of negative moods after SD. In addition, we will do a comparison of the effects of EA on mood after SD at different time points. METHODS: This randomized controlled trial (RCT) will be performed at the First Affiliated Hospital of Changchun University of Chinese Medicine in China. The Standards for Reporting Interventions in Clinical Trials of Acupuncture 2010 will be strictly adhered to. Forty-two healthy male volunteers will be distributed into acupoints electroacupuncture (AE) group, non-acupoints electroacupuncture (NAE) control group, or blank control group. This trial will comprise 1-week baseline (baseline sleep), 1-week preventative treatment, 30-h total sleep deprivation (TSD), and 24-h after waking follow-up period. Participants in the AE group and the NAE control group during the preventative treatment period will be administered with EA treatment once daily for 1 week. Participants in the blank control group will not be administered with any treatment. The primary outcome will be the Profile of Mood States (POMS) Scale. Secondary outcome measures will include changes in the Noldus FaceReader (a tool for automatic analysis of facial expressions) and Positive and Negative Affect Schedule (PANAS) Scale. Total sleep deprivation will be 30 h. During the 30-h TSD period, participants will be subjected to 11 sessions of assessment. Adverse events will be recorded. DISCUSSION: This study is designed to evaluate the efficacy and safety of EA for the prevention of negative moods after SD. The results of this trial will allow us to compare the effects of EA on mood after SD at different time points. Moreover, the findings from this trial will be published in peer-reviewed journals. TRIAL REGISTRATION: Chinese Clinical Trial Registry Chi2000039713 . Registered on 06 November 2020.

Light therapy with boxes or glasses to counteract effects of acute sleep deprivation.

Sleep deprivation, in the context of shift work, is an increasing major public health issue. We aimed to determine whether early light administration can counteract sleep deprivation effects, and to compare LED-glasses with a traditional light therapy box. This cross-over design study included 18 individuals exposed to light therapy for 30 minutes at 5 am after one night of complete sleep deprivation, to mimic the night shift condition. Individuals were randomly exposed to 10,000 Lux light box, 2,000 Lux LED blue-enriched glasses, and control (ambient dim-light at 8 lux). Alertness, cognition and mood were assessed throughout the night and following morning. Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation. A rebound was observed at 8 am resulting from the circadian drive overriding cumulative sleep homeostatic effects. Morning light significantly improved sleepiness and sustained attention from 5 to 7 am. These effects were comparable between devices and significantly different from control. Both devices were overall well and similarly tolerated. Early morning light therapy in the condition of sleep loss may have broad practical applications to improve sleepiness, sustained attention and subsequent risk of accidents.

Evaluation of the anti-fatigue effects of a traditional herbal drug, Gongjin-dan, under insufficient sleep conditions: study protocol for a randomised controlled trial.

BACKGROUND: Many herbal medicines are traditionally used as anti-fatigue agents in east Asian countries; however, there is a dearth of clinical evidence supporting the anti-fatigue effects of such medicines and their mechanisms. This study is a feasibility trial to assess the clinical efficacy of Gongjin-dan (GJD) and verify its mechanisms by exploring fatigue outcomes, including endocrine and immunological biomarkers in humans. METHODS/DESIGN: To investigate the anti-fatigue effects of GJD and the mechanism underlying these effects, a randomised, double-blind, placebo-controlled crossover clinical trial was designed. Participants (24 healthy male volunteers) will be hospitalised for 4 days (3 nights), during which acute fatigue and stress conditions will be induced by sleep deprivation, and GJD or a placebo will be administered (twice daily). The primary outcome will be changes in serum cortisol levels, measured in the morning, as an objective biomarker of sleep deprivation-induced fatigue and stress. The secondary outcomes will include: the Fatigue Severity Scale; the Brief Fatigue Inventory, and the Leeds Sleep Evaluation Questionnaire scores; levels of salivary cortisol, epinephrine, norepinephrine, oxidative stress-related biomarkers, homocysteine, and immunological factors; and heart rate variability. After a washout period of more than 4 weeks, a second treatment phase will commence in which participants who were previously administered the placebo will receive the drug and vice versa, following the same treatment regime as in the first phase. DISCUSSION: This study protocol provides a unique opportunity to enhance our understanding of fatigue and the effects of GJD on fatigue in terms of endocrine and immunological mechanisms by validating the study design and determining feasibility. Findings from this trial will help researchers to design a pilot or definitive clinical trial of traditional herbal medicine for chronic fatigue. TRIAL REGISTRATION: Korean National Clinical Trial Registry CRIS; KCT0001681 , registered on 29 October 2015.

Multicomponent cognitive-behavioural intervention to improve sleep in adolescents: a multiple baseline design.

BACKGROUND: Adolescents are prone to sleep problems that have unique developmental aspects and contribute to physical, emotional, and behavioural problems. AIMS: This study evaluated an individualized, multicomponent intervention that considered developmental factors, and promoted age-appropriate autonomy in three adolescent females with disrupted sleep. METHOD: Adolescents recorded sleep data on daily logs. A nonconcurrent multiple baseline design was used to evaluate a cognitive-behavioural intervention including sleep hygiene training, bedtime routine development, cognitive restructuring, relaxation training, stimulus control, sleep restriction, bedtime fading, and problem-solving, along with clinically indicated individualization. RESULTS: Outcomes demonstrated clinically meaningful improvements and decreased variability in sleep parameters following intervention. Each participant's sleep log data indicated improvement in, or maintenance of, adequate total sleep time (TST), decreased sleep onset latency (SOL), improved sleep efficiency (SE), improvement in time of sleep onset, and decreased or continued low frequency of night awakenings (NA). Anecdotally, adolescents and parents reported improvement in daytime functioning, coping, and sense of wellbeing. CONCLUSIONS: These cases highlight the potential for cognitive-behavioural interventions to facilitate healthy sleep in adolescents with challenging sleep problems.

Non-pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review.

OBJECTIVES: Despite the known adverse effects of sleep deprivation on recovery from illness, studies have shown that sleep deprivation remains an incompletely addressed problem among acutely ill inpatients. Behavioral interventions are recommended as first-line therapy prior to using pharmacologic therapy due to the side effects of sedative hypnotics. The objective of this systematic review was to identify non-pharmacologic interventions that have been used to improve sleep quality and quantity of non-intensive care unit (ICU) inpatients. DATA SOURCES: PubMed, Embase, Web of Science, CINAHL, and Cochrane Library through January 2013; manual searches of reference lists. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, INTERVENTIONS: Any study in which a non-pharmacologic intervention was conducted in a general inpatient setting, and nighttime sleep quantity or quality was assessed. STUDY APPRAISAL AND SYNTHESIS METHODS: Information on study design, populations, interventions, comparators, outcomes, time frame, and risk of bias were independently abstracted by two investigators. RESULTS: 13 intervention studies with 1,154 participants were included. Four studies were randomized controlled trials. Seven studies had a low to medium risk of bias, and there was significant heterogeneity in the interventions. Relaxation techniques improved sleep quality 0-38%, interventions to improve sleep hygiene or reduce sleep interruptions improved sleep quantity 5%, and daytime bright light exposure improved sleep quantity 7-18%. LIMITATIONS: The heterogeneity in the types and dose of interventions, outcome measures, length of follow-up, differences in patient populations, and dearth of randomized trials may dilute effects seen or make it more difficult to draw conclusions. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS: There is insufficient to low strength of evidence that any non-pharmacologic intervention improves sleep quality or quantity of general inpatients. Further studies are needed in this area to guide clinicians.

Melanin concentrating hormone in central hypersomnia.

BACKGROUND: Narcolepsy with cataplexy (NC) is a disabling disorder characterized by excessive daytime sleepiness and abnormal rapid eye movement (REM) sleep manifestations, due to a deficient hypocretin/orexin neurotransmission. Melanin concentrating hormone (MCH) neurons involved in the homeostatic regulation of REM sleep are intact. We hypothesized that an increased release of MCH in NC would be partly responsible for the abnormal REM sleep manifestations. METHODS: Twenty-two untreated patients affected with central hypersomnia were included: 14 NC, six idiopathic hypersomnia with long sleep time, and two post-traumatic hypersomnia. Fourteen neurological patients without any sleep disorders were included as controls. Using radioimmunoassays, we measured hypocretin-1 and MCH levels in cerebrospinal fluid (CSF). RESULTS: The MCH level was slightly but significantly lower in patients with hypersomnia (98 ± 32 pg/ml) compared to controls (118 ± 20 pg/ml). After exclusion of patients affected with post-traumatic hypersomnia the difference became non-significant. We also failed to find any association between MCH level and hypocretin level, the severity of daytime sleepiness, the number of SOREMPs, the frequency of cataplexy, and the presence of hypnagogic hallucinations or sleep paralysis. CONCLUSION: This study reports the first measurement of MCH in CSF using radioimmunoassay technology. It appears to be a non-informative tool to differentiate etiologies of central hypersomnia with or without REM sleep dysregulation.

Sleep and delirium in ICU patients: a review of mechanisms and manifestations.

Sleep deprivation and delirium are conditions commonly encountered in intensive care unit patients. Sleep in these patients is characterized by sleep fragmentation, an increase in light sleep, and a decrease of both slow wave sleep and rapid eye movement sleep. The most common types of delirium in this population are hypoactive and mixed-type. Knowledge about the mechanisms of sleep and delirium has evolved over time, but these phenomena are not yet well understood. What is known, however, is that different areas in the brainstem transmit information to the thalamus and cortex necessary for sleep-wake regulation. Delirium is related to an imbalance in the synthesis, release, and inactivation of some neurotransmitters, particularly acetylcholine and dopamine. The relationship between sleep deprivation and delirium has been studied for many years and has been viewed as reciprocal. The link between them may be ascribed to shared mechanisms. An imbalance in neurotransmitters as well as alteration of melatonin production may contribute to the pathogenesis of both phenomena. A better understanding of the mechanisms and factors that contribute to sleep deprivation and delirium can guide the development of new methods and models for prevention and treatment of these problems and consequently improve patient outcomes.

Examining the feasibility of implementing specific nursing interventions to promote sleep in hospitalized elderly patients.

Sleep deprivation and subsequent effects on health restoration have been documented in the literature. The purpose of this experimental pilot study was to examine the feasibility of implementing specific nursing interventions to promote sleep in hospitalized older adults. The experimental group received a sleep protocol intervention while the control group received usual nighttime care. While no differences were noted in sleep quality and duration between groups, the experimental group experienced better sleep quality (P = .001), ability to remain asleep (P = .018) and used fewer sleep medications than the control group (P = .044). In addition, those taking sleep medications experienced more awakenings and fewer sleep hours. Experimental group patients identified preferences such as personal hygiene, awareness of normal bedtime, receiving a back rub, straightening bed linens, and receiving a bedtime snack. This pilot provides initial support for the feasibility and utility of implementing a sleep protocol in an acute care setting.

Nightmare complaints in treatment-seeking patients in clinical sleep medicine settings: diagnostic and treatment implications.

STUDY OBJECTIVES: To develop clinical guideposts to identify patients with salient nightmare conditions. DESIGN: Prevalence data from a retrospective chart review on a consecutive series of sleep patients to assess how or whether those with nightmares (1) rank nightmare complaints compared to other sleep complaints, (2) link nightmares to disrupted sleep, (3) report worse sleep symptoms and health outcomes compared to other sleep patients, and (4) endorse criteria for a salient nightmare condition on the Disturbing Dream and Nightmare Severity Index. SETTING: Two community sleep facilities: private sleep medical center and a hospital-based sleep lab. PATIENTS: Seven hundred eighteen patients presenting at intake: sleep center (n = 620); sleep lab (n = 98). MEASUREMENTS AND RESULTS: Standard sleep parameters and various health outcomes were assessed with self-report measures. Of 718 sleep patients, 186 ranked a nightmare complaint among their sleep problems, of whom 117 linked their bad dreams to disrupted sleep, suggesting a potential salient nightmare condition. Compared to all other sleep patients, these 117 cases demonstrated consistent significant patterns of worse or more prevalent problems with self-reported sleep indexes, insomnia, sleep quality, sleep-fragmentation factors, sleep-related daytime impairment, psychiatric history, medical comorbidity, and parasomnias. The Disturbing Dream and Nightmare Severity Index identified those with salient nightmare complaints and correlated with worse sleep and health outcomes. CONCLUSIONS: At 2 sleep medical facilities, 16% of patients presented with an apparent salient nightmare condition, and these patients were identified with simple clinical guideposts, which could be incorporated at intake in various sleep medicine settings.

Effect of stage 1 sleep on auditory cortex during pure tone stimulation: evaluation by functional magnetic resonance imaging with simultaneous EEG monitoring.

BACKGROUND AND PURPOSE: Responses of the auditory cortex to sound during sleep have been explored with somewhat discrepant results. The purpose of this study was to investigate the effect of stage 1 sleep on signal intensity changes in the auditory cortex in response to pure tone stimulus measured by functional MR imaging. METHODS: Six sleep-deprived subjects were exposed to a series of echo-planar images for 30-40 minutes. No medication was used to help the subjects go to sleep. A long repetition time of 12 seconds and a 1.9-second clustered multisection acquisition were used to minimize the effect of imager acoustic noise from the preceding acquisition and to make it possible to obtain electroencephalographs between image acquisitions. A pure tone stimulus (beep, 1,000-Hz sine waves, 30-millisecond duration, five beeps per second) was alternated with the baseline every 36 seconds. RESULTS: All subjects fell asleep. The effect of habituation evaluated by comparing the percentage of signal intensity change between the first and second half was not significant. The percentage of signal intensity changes in the right and left transverse temporal gyri were 0.49% and 0.43% during wakefulness and 0.05% and 0.07% during stage 1 sleep. The differences between wakefulness and stage 1 sleep were significant. CONCLUSION: Transition to stage 1 sleep coincides with a decrease in functional MR imaging-determined signal intensity changes in the auditory cortex in response to pure tone stimulus. The limited response of the brain at this stage may protect the brain from sound and facilitate deepening of the sleep stage.

Phosphorous31 magnetic resonance spectroscopy after total sleep deprivation in healthy adult men.

STUDY OBJECTIVES: To investigate chemical changes in the brains of healthy adults after sleep deprivation and recovery sleep, using phosphorous magnetic resonance spectroscopy. DESIGN: Three consecutive nights (baseline, sleep deprivation, recovery) were spent in the laboratory. Objective sleep measures were assessed on the baseline and recovery nights using polysomnography. Phosphorous magnetic resonance spectroscopy scans took place beginning at 7 am to 8 am on the morning after each of the 3 nights. SETTING: Sleep laboratory in a private psychiatric teaching hospital. PARTICIPANTS: Eleven healthy young men. INTERVENTIONS: Following a baseline night of sleep, subjects underwent a night of total sleep deprivation, which involved supervision to ensure the absence of sleep but was not polysomnographically monitored. MEASUREMENTS AND RESULTS: No significant changes in any measure of brain chemistry were observed the morning after a night of total sleep deprivation. However, after the recovery night, significant increases in total and beta-nucleoside triphosphate and decreases in phospholipid catabolism, measured by an increase in the concentration of glycerylphosphorylcholine, were observed. Chemical changes paralleled some changes in objective sleep measures. CONCLUSIONS: Significant chemical changes in the brain were observed following recovery sleep after 1 night of total sleep deprivation. The specific process underlying these changes is unclear due to the large brain region sampled in this exploratory study, but changes may reflect sleep inertia or some aspect of the homeostatic sleep mechanism that underlies the depletion and restoration of sleep. Phosphorous magnetic resonance spectroscopy is a technique that may be of value in further exploration of such sleep-wake functions.

Hypothalamic hamartoma in adults.

Epilepsy in adult patients with hypothalamic hamartoma has not been well studied. It is uncommon but merits recognition. In this paper, 14 adult patients with hypothalamic hamartoma and epilepsy, of whom three developed epilepsy only in adult life, are presented. The later onset of epilepsy appears to be associated with a milder epilepsy syndrome, less severe learning difficulties and behaviour problems, and better occupational and social status. Gelastic seizures are less prominent in this age group. Of particular interest, one patient had prominent sleep disturbances characterized by a reduction in total slow wave and REM sleep without daytime sleepiness. The milder epilepsy and preserved cognitive and social functioning have implications for management. A number of patients were controlled by anticonvulsant medication, and were functioning satisfactorily. For such patients minimally invasive surgical procedures, or medical therapy should be considered.