scholarly journals Quantitative analysis of the placebo response in pharmacotherapy of insomnia and its application in clinical trials

SLEEP ◽  
2019 ◽  
Vol 43 (5) ◽  
Author(s):  
Xijun Zheng ◽  
Yingchun He ◽  
Ling Xu ◽  
Yunfei Li ◽  
Fang Yin ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Drug Development ◽  
Sleep Onset ◽  
Placebo Response ◽  
Sleep Diary ◽  
Cochrane Library ◽  
Design Decision ◽  
Response Models ◽  
Sleep Parameters ◽  
Baseline Levels

Abstract Study Objectives This study aimed to develop a robust placebo response model for the pharmacotherapy for insomnia to guide drug development and clinical practice. Methods PubMed, EMBASE, and Cochrane Library databases were systematically searched for randomized placebo-controlled trials of medications for insomnia dating from the inception dates of the databases to April 18, 2018. Three placebo response models were established to describe the time–course of sleep parameters measured by objective (polysomnography or actigraphy) or subjective methods (sleep diary or questionnaires). The established models were applied to simulate placebo response distribution under different conditions using Monte Carlo simulations. Results Fifty-four studies involving 6,416 subjects were included. Placebo response increased over time and reached a plateau at approximately 8 weeks from start of therapy. Established models described the observed data reasonably well based on various diagnostic plots. Baseline sleep parameters affected the placebo response. There were significant positive correlations with placebo response and the severity of sleep latency, wake after sleep onset, and total sleep time at baseline. In addition, placebo response, assessed by subjective and objective methods, was consistent after correcting the baseline levels. Conclusions The established placebo response models can serve as a tool to predict placebo response at different baseline levels, which can provide valuable reference for clinical trial design, decision-making in drug development, and clinical practice.

Mindfulness and Behaviour Therapy for Insomnia: An Assessment of Treatment Effect in a Sleep Disorders Clinic Population with Insomnia

2020 ◽  
pp. 1-15
Author(s):  
Allie Peters ◽  
John Reece ◽  
Hailey Meaklim ◽  
Moira Junge ◽  
David Cunnington ◽  
...  
Keyword(s):  
Sleep Disorders ◽  
Treatment Effect ◽  
Sleep Onset ◽  
Sleep Efficiency ◽  
Health Concern ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Subjective Sleep ◽  
Sleep Parameters

Abstract Insomnia is a common major health concern, which causes significant distress and disruption in a person's life. The objective of this paper was to evaluate a 6-week version of Mindfulness-Based Therapy for Insomnia (MBTI) in a sample of people attending a sleep disorders clinic with insomnia, including those with comorbidities. Thirty participants who met the DSM-IV-TR diagnosis of insomnia participated in a 6-week group intervention. Outcome measures were a daily sleep diary and actigraphy during pre-treatment and follow-up, along with subjective sleep outcomes collected at baseline, end-of-treatment, and 3-month follow-up. Trend analyses showed that MBTI was associated with a large decrease in insomnia severity (p < .001), with indications of maintenance of treatment effect. There were significant improvements in objective sleep parameters, including sleep onset latency (p = .005), sleep efficiency (p = .033), and wake after sleep onset (p = .018). Significant improvements in subjective sleep parameters were also observed for sleep efficiency (p = .005) and wake after sleep onset (p < .001). Overall, this study indicated that MBTI can be successfully delivered in a sleep disorders clinic environment, with evidence of treatment effect for both objective and subjective measures of sleep.

Sleep Quality Associated With Different Work Schedules: A Longitudinal Study of Nursing Staff

2017 ◽  
Vol 19 (4) ◽  
pp. 375-381 ◽  
Author(s):  
Shu-Fen Niu ◽  
Nae-Fang Miao ◽  
Yuan-Mei Liao ◽  
Mei-Ju Chi ◽  
Min-Huey Chung ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Night Shift ◽  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Shift Group ◽  
Parallel Group ◽  
Sleep Parameters ◽  
Work Shifts

Purpose: To explore the differences in sleep parameters between nurses working a slow, forward rotating shift and those working a fixed day shift. Method: A longitudinal parallel-group comparison design was used in this prospective study. Participants (female) were randomly assigned to a rotating shift or a fixed day shift group. Participants in the rotating shift group worked day shift for the first 4 weeks, followed by evening shift for the second and night shift the third. Those in the day shift group worked day shift for all 12 weeks. Each kept a sleep diary and wore an actigraph (actigraph data were used to calculate total sleep time [TST], sleep onset latency [SOL], wake after sleep onset [WASO], and sleep efficiency [SE]) for 12 days, from Workday 1–4 in each of Weeks 4, 8, and 12. Results: TST in nurses working evening rotating shift was higher than that for those working the day or night rotating shift and fixed day shift. WASO was significantly longer on Day 2 for rotating shift participants working evening versus day shift. SOL and SE were significantly shorter and lower in rotating shift nurses working night versus both day and evening shifts. Conclusions: A comprehensive understanding of the sleep patterns and quality of nurses with different work shifts may lead to better management of work shifts that reduces the influence of shift work on sleep quality.

scholarly journals 0178 The Cycle of Daily Stress and Sleep: Sleep Measurement Matters

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A70-A71
Author(s):  
D C Slavish ◽  
J Asbee ◽  
K Veeramachaneni ◽  
B Messman ◽  
B Scott ◽  
...  
Keyword(s):  
Sleep Disturbances ◽  
Multilevel Models ◽  
Single Channel ◽  
Sleep Onset ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Daily Stress ◽  
Sleep Diaries ◽  
Sleep Parameters ◽  
Sleep Measurement

Abstract Introduction Disturbed sleep can be both a cause and a consequence of increased stress. Yet intensive longitudinal studies have demonstrated that sleep assessed via sleep diaries and actigraphy is inconsistently associated with daily stress. We expanded this research by examining daily associations between sleep and stress using a three-fold approach to assess sleep: sleep diaries, actigraphy, and ambulatory single-channel electroencephalography [EEG]. Methods Participants were 80 adults (M age = 32.65 years, 63% female) who completed 7 days of sleep and perceived stress assessments in a naturalistic setting (resulting in 560 possible measurement occasions). Multilevel models were used to examine bidirectional associations between daily stressor occurrence (0 = stressor did not occur, 1 = stressor occurred) and stressor severity (0 = not at all severe to 3 = very severe) and sleep parameters assessed via diary, actigraphy, and EEG (e.g. total sleep time [TST], sleep efficiency [SE], and sleep onset latency [SOL], wake after sleep onset [WASO]). Results Participants reported at least one stressor on 37% of days. Compared to days without a stressor experienced, days with a stressor were associated with a 14.4-minute reduction in actigraphy-determined TST the subsequent night (β = -0.24, p = 0.030). Nights with greater sleep-diary determined WASO were associated with greater next-day stressor severity (β = 0.01, p = .026). No EEG-determined sleep parameters were associated with next-day stressor occurrence or severity, or vice versa. Conclusion Daily stress and sleep disturbances occurred in a bidirectional fashion, though specific results varied by sleep measurement technique and sleep parameter. Together, our results highlight that type of sleep measurement matters for examining associations with daily stress. We urge future researchers to treat sleep diaries, actigraphy, and EEG as complementary — not redundant — sleep measurement approaches. Support Funding for this study included NIH/NIAID R01AI128359-01; DoD-VA 1I01CU000144-01; the Foundation for Rehabilitation Psychology; and General Sleep Corporation.

scholarly journals 0480 Efficacy and Safety of Lemborexant in Female Subjects of Perimenopausal Age with Insomnia Disorder

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A184-A184
Author(s):  
J Cheng ◽  
J Yardley ◽  
K Pinner ◽  
M Moline
Keyword(s):  
Sleep Onset ◽  
Safety Data ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Efficacy And Safety ◽  
Subjective Sleep ◽  
Perimenopausal Women ◽  
Sleep Parameters ◽  
Age Range ◽  
Female Subjects

Abstract Introduction Insomnia is common in women in the perimenopausal age range. We present 12-month efficacy and safety data for the subgroup of female subjects in the age range associated with perimenopause (age 40-58y) from SUNRISE-2 (NCT02952820; E2006-G000-303). Methods SUNRISE-2 was a 12-month, randomized, double-blind, placebo (PBO)-controlled (first 6mo [Period 1]), global phase 3 study. During Period 1, subjects received PBO or lemborexant (LEM: 5mg, [LEM5]; 10mg, [LEM10]). During Period 2 (second 6mo), LEM subjects continued their assigned dose. PBO subjects were rerandomized to LEM5 or LEM10 (not reported here). Changes from baseline in subjective sleep parameters: subjective sleep onset latency (sSOL), sleep efficiency (sSE), wake after sleep onset (sWASO) were assessed from sleep diary data. Results The perimenopausal subgroup comprised 280 subjects (Period 1: PBO, n=90; LEM5, n=82; LEM10, n=108). Baseline median sSOL (min) was 57.5, 51.1, and 54.0 for PBO, LEM5, and LEM10. Greater median decreases from baseline in sSOL (min) occurred at 6mo with LEM vs PBO (PBO, −17.9; LEM5, −20.7; LEM10, −30.4); improvements persisted at 12mo (LEM 5, −27.7; LEM10, −33.9). Baseline mean[SD] sSE was 59.9%[16.6%], 60.7%[20.0%], and 61.2%[17.5%] for PBO, LEM5, and LEM10. Greater mean[SD] increases from baseline in sSE (%) occurred at 6mo with LEM vs PBO (PBO, 12.5%[15.0%]; LEM5, 15.9%[17.0%]; LEM10, 17.2%[14.7%]); improvement persisted at 12mo (LEM5,17.6%[18.2%]; LEM10, 19.1%[14.8%]). Baseline mean[SD] sWASO (min) was 134.9[70.8], 142.4[86.5], and 136.5[84.4]. Greater mean[SD] decreases from baseline in sWASO (min) occurred at 6mo with LEM vs PBO (PBO, −37.0[59.6]; LEM5, −50.1[74.5]; LEM10 −54.5[65.4]); improvement persisted at 12mo (LEM5, −59.1[76.7]; LEM10, −66.2[64.9]). Most treatment emergent adverse events (TEAEs) were mild/moderate. Conclusion Consistent with previously reported data from the total population, subjective sleep parameters improved, and improvement was sustained over time in perimenopausal women. LEM was well tolerated, supporting LEM as a potential treatment option for perimenopausal women with insomnia. Support Eisai Inc.

scholarly journals Comparison of single-channel EEG, actigraphy, and sleep diary in cognitively normal and mildly impaired older adults

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Chris A Chou ◽  
Cristina D Toedebusch ◽  
Tiara Redrick ◽  
David Freund ◽  
Jennifer S McLeland ◽  
...  
Keyword(s):  
Older Adults ◽  
Sleep Disturbances ◽  
Single Channel ◽  
Sleep Onset ◽  
Amyloid Β ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Cognitively Normal ◽  
Sleep Diaries ◽  
Sleep Parameters

Abstract Study Objectives Multiple methods for monitoring sleep-wake activity have identified sleep disturbances as risk factors for Alzheimer disease (AD). In order to identify the level of agreement between different methods, we compared sleep parameters derived from single-channel EEG (scEEG), actigraphy, and sleep diaries in cognitively normal and mildly impaired older adults. Methods Two hundred ninety-three participants were monitored at home for up to six nights with scEEG, actigraphy, and sleep diaries. Total sleep time (TST), sleep efficiency (SE), sleep onset latency (SOL), and wake after sleep onset (WASO) were calculated using each of these methods. In 109 of the 293 participants, the ratio of cerebrospinal fluid concentrations of phosphorylated tau (p-tau) and amyloid-β-42 (Aβ42) was used as a biomarker for AD pathology. Results Agreement was highest for TST across instruments, especially in cognitively normal older adults. Overall, scEEG and actigraphy appeared to have greater agreement for multiple sleep parameters than for scEEG and diary or actigraphy and diary. Levels of agreement between scEEG and actigraphy overall decreased in mildly impaired participants and those with biomarker evidence of AD pathology, especially for measurements of TST. Conclusions Caution should be exercised when comparing scEEG and actigraphy in individuals with mild cognitive impairment or with AD pathology. Sleep diaries may capture different aspects of sleep compared to scEEG and actigraphy. Additional studies comparing different methods of measuring sleep-wake activity in older adults are necessary to allow for comparison between studies using different methods.

scholarly journals P121 Comparison of Actigraphy versus PSG and Perception of Sleep in Patients with Excessive Daytime Sleepiness

2021 ◽  
Vol 2 (Supplement_1) ◽  
pp. A60-A61
Author(s):  
T Roebuck ◽  
E McDermott ◽  
R Cuesta ◽  
R Nguy ◽  
M Spiteri ◽  
...  
Keyword(s):  
Sleep Latency ◽  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Onset Latency ◽  
Activity Data ◽  
Significant Difference ◽  
Sleep Parameters ◽  
Perception Of Sleep

Abstract Actigraphy is used as a validated measure of rest and sleep, however, there are reported differences in WASO in healthy individuals (Chinoy, 2021). Methods This study compares the sleep parameters from PSG with simultaneous overnight actigraphy on patients the night prior to MSLT. We also compare the actigraphy data collected on the week prior to the PSG with the patient’s sleep diary. 22 subjects, age 38.7 ± 3.1 years, BMI 23.5 ± 1.4 kg/m2, 40.1% male, 4 participants were treated with CPAP. Results WASO was found to be under estimated by actigraphy versus PSG (y=-0.957x+18.014, R2=0.51), there is an increase in underestimation beyond 18minutes. Our data also show on overestimation of sleep onset latency by actigraphy versus PSG when sleep latency is longer than 12 minutes (y=0.27x-12.04, R2=0.08). Total sleep time was perceived to be longer on the PSG night than the PSG data shows (y=0.68x-4.65, R2=0.21). Data demonstrated participants to overestimate their sleep period in their sleep diary compared to the actigraphy data (y=-0.87x+6.58, R2=0.21). T-tests showed a significant difference between WASO (minutes) detected by PSG and the actigraphy data (67.4 ± 8.9 vs 33.3 ± 3.9 p=0.0007). There were no other significant differences in the datasets. Conclusion Actigraphy uses activity data and light detection to estimate rest and sleep periods in wearers. Our data reflects expected differences reported in the literature of actigraphy data versus PSG due to the limitation of actigraphy being able to differentiate between sleep and motionless wakefulness.

scholarly journals Evening intake of alcohol, caffeine, and nicotine: night-to-night associations with sleep duration and continuity among African Americans in the Jackson Heart Sleep Study

SLEEP ◽  
2019 ◽  
Vol 42 (11) ◽  
Author(s):  
Christine E Spadola ◽  
Na Guo ◽  
Dayna A Johnson ◽  
Tamar Sofer ◽  
Suzanne M Bertisch ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Sleep Duration ◽  
Sleep Onset ◽  
Sleep Efficiency ◽  
Sleep Diary ◽  
Sleep Study ◽  
Mixed Effect ◽  
Wrist Actigraphy ◽  
Sleep Parameters ◽  
Predominantly Female

Abstract Study Objectives We examined the night-to-night associations of evening use of alcohol, caffeine, and nicotine with actigraphically estimated sleep duration, sleep efficiency, and wake after sleep onset (WASO) among a large cohort of African American adults. Methods Participants in the Jackson Heart Sleep Study underwent wrist actigraphy for an average of 6.7 nights and completed concurrent daily sleep diary assessments to record any consumption of alcohol, caffeine, and nicotine within 4 hours of bedtime. Linear mixed-effect models were fit and adjusted for age, sex, educational attainment, body mass index, depression, anxiety, stress, and having work/school the next day. Results Eligible participants (n = 785) were an average of 63.7 years (SD: 10.6), and were predominantly female (67.9%). There were 5164 days of concurrent actigraphy and sleep diary data. Evening alcohol use was associated with that night’s lower sleep efficiency (−0.98% [95% CI: −1.67% to −0.29%], p = 0.005), but not with WASO or sleep duration. Evening nicotine use was associated with that night’s lower sleep efficiency [1.74% (95% CI: −2.79 to −0.68), p = 0.001] and 6.09 minutes higher WASO ([95% CI: 0.82 to 11.35], p = 0.02), but was not associated with sleep duration. Evening caffeine use was not associated with any of the sleep parameters. Conclusion Nicotine and alcohol use within 4 hours of bedtime were associated with increased sleep fragmentation in the associated night, even after controlling for multiple potential confounders. These findings support the importance of sleep health recommendations that promote the restriction of evening alcohol and nicotine use to improve sleep continuity.

scholarly journals Enablers and barriers to treatment adherence in heterozygous familial hypercholesterolaemia: a qualitative evidence synthesis

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e030290 ◽  
Author(s):  
Fiona J Kinnear ◽  
Elaine Wainwright ◽  
Rachel Perry ◽  
Fiona E Lithander ◽  
Graham Bayly ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Treatment Adherence ◽  
Familial Hypercholesterolaemia ◽  
Family Members ◽  
Personal Control ◽  
Qualitative Studies ◽  
Cochrane Library ◽  
Barriers To Treatment ◽  
Thematic Synthesis ◽  
Heterozygous Familial Hypercholesterolaemia

ObjectivesIndividuals with heterozygous familial hypercholesterolaemia (FH) are at high risk of developing cardiovascular disease (CVD). This risk can be substantially reduced with lifelong pharmacological and lifestyle treatment; however, research suggests adherence is poor. We synthesised the qualitative research to identify enablers and barriers to treatment adherence.DesignThis study conducted a thematic synthesis of qualitative studies.Data sourcesMEDLINE, Embase, PsycINFO via OVID, Cochrane library and CINAHL databases and grey literature sources were searched through September 2018.Eligibility criteriaWe included studies conducted in individuals with FH, and their family members, which reported primary qualitative data regarding their experiences of and beliefs about their condition and its treatment.Data extraction and synthesisQuality assessment was undertaken using the Critical Appraisal Skills Programme for qualitative studies. A thematic synthesis was conducted to uncover descriptive and generate analytical themes. These findings were then used to identify enablers and barriers to treatment adherence for application in clinical practice.Results24 papers reporting the findings of 15 population samples (264 individuals with FH and 13 of their family members) across 8 countries were included. Data captured within 20 descriptive themes were considered in relation to treatment adherence and 6 analytical themes were generated: risk assessment; perceived personal control of health; disease identity; family influence; informed decision-making; and incorporating treatment into daily life. These findings were used to identify seven enablers (eg, ‘commencement of treatment from a young age’) and six barriers (eg, ‘incorrect and/or inadequate knowledge of treatment advice’) to treatment adherence. There were insufficient data to explore if the findings differed between adults and children.ConclusionsThe findings reveal several enablers and barriers to treatment adherence in individuals with FH. These could be used in clinical practice to facilitate optimal adherence to lifelong treatment thereby minimising the risk of CVD in this vulnerable population.PROSPERO registration numberCRD42018085946.

scholarly journals The Cycle of Daily Stress and Sleep: Sleep Measurement Matters

2020 ◽  
Author(s):  
Danica C Slavish ◽  
Justin Asbee ◽  
Kirti Veeramachaneni ◽  
Brett A Messman ◽  
Bella Scott ◽  
...  
Keyword(s):  
Sleep Disturbances ◽  
Multilevel Models ◽  
Single Channel ◽  
Sleep Onset ◽  
Sleep Time ◽  
Sleep Diary ◽  
Sleep Onset Latency ◽  
Daily Stress ◽  
Sleep Diaries ◽  
Sleep Measurement

Abstract Background Disturbed sleep can be a cause and a consequence of elevated stress. Yet intensive longitudinal studies have revealed that sleep assessed via diaries and actigraphy is inconsistently associated with daily stress. Purpose We expanded this research by examining daily associations between sleep and stress using a threefold approach to assess sleep: sleep diaries, actigraphy, and ambulatory single-channel electroencephalography (EEG). Methods Participants were 80 adults (mean age = 32.65 years, 63% female) who completed 7 days of stressor and sleep assessments. Multilevel models were used to examine bidirectional associations between occurrence and severity of daily stress with diary-, actigraphy-, and EEG-determined sleep parameters (e.g., total sleep time [TST], sleep efficiency, and sleep onset latency, and wake after sleep onset [WASO]). Results Participants reported at least one stressor 37% of days. Days with a stressor were associated with a 14.4-min reduction in actigraphy-determined TST (β = −0.24, p = 0.030), but not with other actigraphy, diary, or EEG sleep measures. Nights with greater sleep diary-determined WASO were associated with greater next-day stressor severity (β = 0.01, p = 0.026); no other diary, actigraphy, or EEG sleep measures were associated with next-day stressor occurrence or severity. Conclusions Daily stress and sleep disturbances occurred in a bidirectional fashion, though specific results varied by sleep measurement technique and sleep parameter. Together, our results highlight that the type of sleep measurement matters for examining associations with daily stress. We urge future researchers to treat sleep diaries, actigraphy, and EEG as complementary—not redundant—sleep measurement approaches.

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