FLUID study: study protocol for an open-label, single-centre pilot study to investigate the efFect of Lemborexant on sleep management in Japanese sUbjects aged 50 years and older with Insomnia Disorder

IntroductionBidirectional associations have been reported between sleep disturbance and both cognitive impairment, including Alzheimer’s disease and amyloid beta-peptide (Aβ) accumulation. These relationships can be explained by the glymphatic system, which acts as a garbage drainage system in the brain. As interstitial fluid dynamics are suggested to increase during sleep, clearance of Aβ can be influenced by sleep disturbance or deprivation. We hypothesised that using lemborexant, an orexin receptor antagonist, to improve sleep quality would also improve the function of the glymphatic system. We plan to examine the effect of lemborexant on sleep quality and the glymphatic system among patients with insomnia disorder.Methods and analysisThis pilot study is designed as an open-label, single-arm, single-centre trial. Thirty patients aged 50 years and over with insomnia will be recruited. The participants will take lemborexant (5 mg) at bedtime for 12 weeks and undergo a home-based sleep study at baseline and weeks 4 and 12, as well as MRI examinations to evaluate the glymphatic system at baseline and week 12. The primary outcome will be changes in objective sleep parameters as evaluated using a sleep monitoring system. The secondary outcomes will be changes in subjective sleep parameters. The relationships between changes in sleep parameters and the glymphatic system will be evaluated using diffusion tensor image analysis along the perivascular space, which is called the ALPS-index. Sleep parameters and the ALPS-index will be analysed using a paired t-test or Pearson’s correlation coefficient.Ethics and disseminationThe study protocol was approved by Nagoya University Certified Review Board. The findings from this research will be published in peer-reviewed journals and be presented at local, national and international conferences.Trial registration numberjRCTs041210024.

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0845 The Difference in Sleep Characteristics of Chronic Insomnia Disorder According to Gender and Age

SLEEP ◽

10.1093/sleep/zsaa056.841 ◽

2020 ◽

Vol 43 (Supplement_1) ◽

pp. A322-A322

Author(s):

J Hong ◽

H Lee ◽

I Yoon

Keyword(s):

Sleep Quality ◽

The Elderly ◽

Sleep Time ◽

Chronic Insomnia ◽

Middle Aged ◽

Subjective Sleep ◽

Time In Bed ◽

Insomnia Disorder ◽

Gender And Age ◽

Sleep Parameters

Abstract Introduction Impacts of age and gender on sleep have been reported in normal population, but rarely in chronic insomnia disorder (CID). This study aimed to investigate difference in sleep characteristics of CID according to gender and age. Methods The participants with drug-naïve CID and aged between 40 and 79 years were recruited. We compared subjective and objective sleep parameters between the middle-aged (40-64 years, N=86) and the elderly (65-79 years, N=50), and between men (N=45) and women (N=91). The subjective sleep quality and habitual sleep time were measured by Pittsburgh Sleep Quality Index (PSQI). The participants were asked to wear an actigraph for 4 days to obtain objective sleep parameters. Results In the PSQI, the elderly reported earlier bedtime and wake-up time (p=0.018; p=0.026), reduced total sleep time (TST) and sleep efficiency (p=0.003; p=0.011), and low sleep quality (p=0.034) compared to the middle-aged. However, according to the actigraphy, differences were observed only in the bedtime (p=0.016) and the wake-up time (p=0.002) between the two age groups. Between genders, the actigraphy showed that the male patients woke up earlier than the female group (p=0.015); except for this finding, there was no significant gender effect. Meanwhile, regarding gender and age interactions, the elderly women with CID showed longer time in bed (TIB) with increase in both TST and wake after sleep onset (WASO) compared to the middle-aged women. The elderly men showed decreased TIB and TST, and slightly decreased WASO than the middle-aged men. Conclusion The elderly with CID show more subjective sleep complaints than the middle-aged CID despite little difference in objective sleep characteristics, which suggests that the elderly CID may seek medical help more than the middle aged. As women with CID get older, they increase time spent in bed to maintain sleep time, but with resultant increase in wake. Support None

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Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study

International Journal of Breast Cancer ◽

10.1155/2018/2479274 ◽

2018 ◽

Vol 2018 ◽

pp. 1-8

Author(s):

Gabriela Näf ◽

Urs E. Gasser ◽

Hans E. Holzgang ◽

Sandra Schafroth ◽

Christoph Oehler ◽

...

Keyword(s):

Pilot Study ◽

Skin Reaction ◽

Camellia Sinensis ◽

Acute Radiation ◽

Control Group ◽

Data Sets ◽

Single Centre ◽

Open Label ◽

Whole Breast Radiotherapy ◽

Radiation Induced

Background. To assess effectiveness of NPE, a proprietary Camellia sinensis nonfermentatum (CSNF) extract, in prevention and recovery of acute radiation-induced skin reaction (ARSR) and skin care during postoperative whole breast radiotherapy (RT). Methods. Twenty patients were enrolled in this single centre, prospective, open-label pilot study. The outcomes of 20 prospective data sets were compared with 100 retrospectively collected matched data sets derived from hospital records. The preventive CSNF gel (2.5%) was administered 1 to 2 hours before each session on the irradiated fields. The care CSNF lotion (0.4%) was administered as 7-day pretreatment after each RT session, twice daily between RT sessions, and 4 to 8 weeks thereafter. The control group was treated according to the hospital care guidelines. The primary endpoint was time to ARSR ≥ Grade 2 (CTCAE v4.03); secondary endpoints were frequencies of ARSR grades 1, 2, 3, and 4, recovery of ARSR, frequencies of interruption and RT stop, complications and required rescue interventions, and tolerability of CSNF. Results. Time to ARSR ≥ G2 (censoring) was significantly longer (p = 0.014) in the CSNF group. The hazard ratio was 2.33 (95% CI: 1.15–4.72), demonstrating a 50% decrease in the risk of developing ARSR ≥ G2. There was a trend to faster recovery from ARSR G2 in the CSNF group (100% versus 47%; p = 0.078). The proportion of patients requiring rescue treatment during RT and follow-up was markedly higher in the control compared to the CSNF group (1% to 51% versus 0% to 15%). CSNF gel and lotion were well tolerated both during and after RT. Conclusions. This pilot study provides the first evidence on the potential pharmacological effectiveness of CSNF extract in prevention of RT-induced ARSR and recovery of skin irritation in patients undergoing postoperative whole breast RT and may reflect a novel concept for prevention of RT-induced ARSR and care of irritated skin.

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The Stimulation Effect of Auricular Magnetic Press Pellets on Older Female Adults with Sleep Disturbance Undergoing Polysomnographic Evaluation

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2013/530438 ◽

2013 ◽

Vol 2013 ◽

pp. 1-8 ◽

Cited By ~ 4

Author(s):

Chyi Lo ◽

Wen-Chun Liao ◽

Jen-Jiuan Liaw ◽

Liang-Wen Hang ◽

Jaung-Geng Lin

Keyword(s):

Sleep Quality ◽

Sleep Disturbance ◽

Depression Scale ◽

Analysis Of Covariance ◽

Sleep Stages ◽

Control Group ◽

Parallel Group ◽

Sleep Parameters ◽

Auricular Therapy ◽

Experimental Group

Study Objectives. To examine the stimulation effect of auricular magnetic press pellet therapy on older female adults with sleep disturbance as determined by polysomnography (PSG).Design. Randomized, single-blind, experimental-controlled, parallel-group.Setting. Community.Participants. Twenty-seven older female adults with sleep disturbance according to the Pittsburgh Sleep Quality Index (PSQI) >5 for at least 3 months were recruited. Participants were screened by both the Hospital Anxiety and Depression Scale (HADS) and the Mini-Mental State Examination (MMSE), as well as polysomnography prior to randomization.Interventions. All eligible participants were randomly allocated into the experimental or control group. Both groups were taped with magnetic press pellet on auricular points for 3 weeks. The experimental group was treated by applying pressure on the magnetic press pellets 3 times per day while no stimulation was applied on the control group.Measurements and Results. Both groups were measured by PSG and PSQI at the beginning of the study and 3 weeks after the study. Both groups showed improvements on PSQI scores compared to the baseline. One-way analysis of covariance adjusted for baseline scores showed that significant improvements of PSG-derived sleep parameters, such as sleep efficiency, were found in the experimental group. However, no significant differences between groups were observed in the proportion of sleep stages with the exception of Stage 2.Conclusions. Auricular therapy using magnetic pellets and stimulation by pressing was more effective in improving the sleep quality compared to auricular therapy without any stimulation.

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An open-label, single-arm pilot study of EUS-guided brachytherapy with phosphorus-32 microparticles in combination with gemcitabine +/- nab-paclitaxel in unresectable locally advanced pancreatic cancer (OncoPaC-1): Technical details and study protocol

Endoscopic Ultrasound ◽

10.4103/eus.eus_44_19 ◽

2020 ◽

Vol 9 (1) ◽

pp. 24 ◽

Cited By ~ 2

Author(s):

ManoopS Bhutani ◽

JosephM Herman ◽

JasonB Klapman ◽

Richard Tuli ◽

Ghassan El-Haddad ◽

...

Keyword(s):

Pancreatic Cancer ◽

Pilot Study ◽

Study Protocol ◽

Locally Advanced ◽

Advanced Pancreatic Cancer ◽

Locally Advanced Pancreatic Cancer ◽

Open Label ◽

Technical Details

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Peripheral venous catheter colonisation after skin disinfection with 0.5% aqueous sodium hypochlorite, preceded or not by one application of 70% ethanol (DACLEAN): A single centre, randomised, open-label, pilot study

Journal of Hospital Infection ◽

10.1016/j.jhin.2021.11.012 ◽

2021 ◽

Author(s):

Bertrand DRUGEON ◽

Maxime PICHON ◽

Nicolas MARJANOVIC ◽

Severine MOUSSE ◽

Sabrina SEGUIN ◽

...

Keyword(s):

Pilot Study ◽

Sodium Hypochlorite ◽

Venous Catheter ◽

Single Centre ◽

Open Label ◽

Aqueous Sodium ◽

Peripheral Venous Catheter ◽

Skin Disinfection ◽

Catheter Colonisation

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Rotigotine Objectively Improves Sleep in Parkinson’s Disease: An Open-Label Pilot Study with Actigraphic Recording

Parkinson s Disease ◽

10.1155/2016/3724148 ◽

2016 ◽

Vol 2016 ◽

pp. 1-5 ◽

Cited By ~ 6

Author(s):

Giovanna Calandra-Buonaura ◽

Pietro Guaraldi ◽

Andrea Doria ◽

Stefano Zanigni ◽

Stefania Nassetti ◽

...

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Pilot Study ◽

Motor Activity ◽

Sleep Quality ◽

Sleep Disturbances ◽

Open Label ◽

Sleep Complaints ◽

Objective Evidence ◽

Rotigotine Treatment

Sleep disturbances represent important predictors of poor quality of life (QoL) in Parkinson’s disease (PD). This open-label pilot study aimed to objectively assess, by means of actigraphic recording, effect of rotigotine on sleep in PD patients with self-reported sleep complaints. 15 PD patients underwent one-week actigraphic recording before (T0) and during (T1) rotigotine treatment, which was titrated to the dose subjectively improving motor symptoms (4–8 mg/24 h). Sleep disturbances, daytime sleepiness, cognitive performance, QoL, and depression were also evaluated with questionnaires. Actigraphic recordings showed a significant reduction in nocturnal motor activity and mean duration of wake episodes after sleep onset during rotigotine treatment compared to baseline. In 10 patients presenting objective evidence of poor sleep quality at T0 (sleep efficiency ≤ 85%), rotigotine also significantly improved other sleep parameters and further reduced nocturnal motor activity and mean duration of wake episodes. A significant decrease in number and duration of daytime sleep episodes was also observed at T1. Finally we confirmed that rotigotine significantly improves perceived sleep quality and QoL. Our study showed for the first time that rotigotine is associated with an objective improvement of nocturnal and diurnal sleep disturbances in PD patients with self-reported sleep complaints. This study is registered with AIFA-observational study registry number 12021.

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Efficacy and Safety of the Traditional Herbal Medicine, Gamiguibi-tang, in Patients With Cancer-Related Sleep Disturbance: A Prospective, Randomized, Wait-List-Controlled, Pilot Study

Integrative Cancer Therapies ◽

10.1177/1534735417734914 ◽

2017 ◽

Vol 17 (2) ◽

pp. 524-530 ◽

Cited By ~ 6

Author(s):

Jee Young Lee ◽

Hye Kyung Oh ◽

Han Sung Ryu ◽

Sung Soo Yoon ◽

Wankyu Eo ◽

...

Keyword(s):

Herbal Medicine ◽

Sleep Quality ◽

Sleep Disturbance ◽

Poor Sleep ◽

Wait List ◽

Efficacy And Safety ◽

Traditional Herbal Medicine ◽

Open Label ◽

Wait List Group ◽

Patients With Cancer

Background: Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. Methods: We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Results: Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (−5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (−0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. Conclusion: GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

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Sleep quality and ventilatory efficiency in elderly heart failure patients: a pilot study on the short-term effect of 4-week low-intensity aerobic exercise

Kardiologiia ◽

10.18087/cardio.2020.6.n938 ◽

2020 ◽

Vol 60 (6) ◽

pp. 102-106

Author(s):

Walid Kamal Abdelbasset ◽

Ahmad Osailan

Keyword(s):

Pilot Study ◽

Sleep Quality ◽

Aerobic Exercise ◽

Sleep Disturbance ◽

Exercise Program ◽

Quality Of Sleep ◽

Short Term ◽

Ventilatory Efficiency ◽

Low Intensity

Background Sleep disturbance and ventilator inefficiency are considered two of the most critical complications for general human wellbeing, particularly in elderly heart failure (HF) patients. Studies examining the effect of low-intensity aerobic exercise in the treatment of sleep disturbance and ventilatory inefficiency in this population of patients are limited.Objective The purpose of the current pilot study was to check the effect of low-intensity aerobic exercise on the quality of sleep and ventilatory efficiency in elderly HF patients.Materials and methods Design: pilot study. Setting: outpatient physical therapy clinic within Cairo University regional hospital. Participants: eight elderly HF patients (6 men, 2 women) with a mean age of 69.4±4.2 years. Intervention: participants were recruited for a low-intensity exercise program (40 to 50% of maximum heart rate for 30-40 minutes), five sessions weekly for four weeks. Exercise intensity was monitored during the sessions using heart rate. Outcome Measure: sleep quality was assessed pre- and post- four weeks of exercise program usingthe Pittsburgh sleep quality index (PSQI) and ventilatory efficiency was assessed using cardiopulmonary exercise test.Results HF patients (II–III NYHA), mean age 69.4±4.2 years, body mass index 23.7±2.7 kg/m2, ejection fraction 32.7±4.5 %, VO2peak 16.27±4.2 ml/kg/min, VE/VCO2 30.81±12.7. The mean of global PSQI score ranged between 8.2 to 11.4 with a mean of 9.7±3.4 which indicates that the participants experienced sleep disturbance. The post-exercise assessment showed that patients have reported a significant improvement of all PSQI domains compared with baseline assessment (p<0.05). VO2peak significantly increased from 16.27±4.2 pre-intervention to 20.03±2.6 ml/kg/min post-intervention (p=0.049) whereas VE/VCO2 slightly decreased with a non-significant difference at the end of the study program (p=0.594) indicating animprovement of ventilator efficiencyand overall cardiorespiratory fitness.Conclusion Short-term application of low-intensity aerobic exercise (4 weeks) may improve the quality of sleep and ventilator efficiency in elderly HF patients. The study findings encourage elderly HF patients with sleep disturbance to adhere to the exercise training program. Also, cardiac rehabilitation programs with low intensity of aerobic exercise should be proposed to these patients by their health care provider.

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Electroacupuncture for treatment-resistant insomnia: study protocol for a randomised, controlled, assessor-blinded, pilot clinical trial

BMJ Open ◽

10.1136/bmjopen-2019-034239 ◽

2020 ◽

Vol 10 (2) ◽

pp. e034239

Author(s):

Jung-Hwa Lim ◽

Kyung-Ok Kim ◽

Sang-Ho Kim ◽

Chang-Wan Kang ◽

Bo-Kyung Kim

Keyword(s):

Pilot Study ◽

Sleep Quality ◽

Usual Care ◽

Study Protocol ◽

Usual Care Group ◽

Sleep Diary ◽

Secondary Outcome ◽

Care Group ◽

Treatment Resistant ◽

Hypnotic Medication

IntroductionA considerable number of insomnia patients experience sleep disturbance even with long-term use of hypnotic medication. Previous studies have indicated that electroacupuncture (EA) could be an efficacious treatment for managing insomnia. However, few trials have been conducted to evaluate the effectiveness and safety of EA for treatment-resistant insomnia. This pilot study aims to explore the feasibility and preliminary effectiveness and safety of EA as an adjunct treatment for treatment-resistant insomnia.Methods and analysisThis is a multicentre, randomised, usual care controlled and assessor-blinded pilot study protocol. Fifty patients presenting with sleep problems who have been taking hypnotic medication for more than 3 months will be randomly allocated to either an EA group or a usual care group at a 1:1 ratio. The EA group will undergo 12 EA treatment sessions twice a week for 6 weeks whereas the usual care group will not receive EA treatment. All the participants will receive a brochure containing educational information on sleep hygiene. The primary outcome will be the measured mean change of the total score of the Insomnia Severity Index from the baseline to week 7. The secondary outcome regarding sleep quality will be measured using the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Moreover, we will assess the quality of life, the direct and indirect cost of treating insomnia for economic evaluation. After 4 weeks, the subjects will visit the research sites for a follow-up assessment.Ethics and disseminationEthical approval of this study protocol was established by the institutional review boards of the each involved study site. All potential subjects will be provided written informed consent. The results of this study will be accessible in peer-reviewed publications and be presented at academic conference.Trial registration numberKCT0003235.

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